Open Congress : News Articles for S.510 Research of Alcohol Detection Systems for Stopping Alcohol-related Fatalities Everywhere Act of 2011

Medical Device Daily Wins Prestigious SIPA Award for Outstanding Business Journalism

2012-07-27T04:51:23Z

ATLANTA, July 13, 2012 /PRNewswire-USNewswire/ -- AHC Media's Medical Device Daily, announced today that its report titled "Medical Device Daily's 510(k) Regulatory Pathway: How Coming Changes From the FDA May Profoundly Transform the Med-Tech Sector," won

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K-Y Moisturizer Recalled by FDA: What You Should Know

2012-07-24T11:28:39Z

It offers women a safe, effective solution to vaginal dryness and has received the FDA's 510(k) clearance, a requirement many companies have not met. Replens is estrogen free and long-lasting and has been clinically tested and shown to be as ...

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Women Worry That They Are Fat Three Times A Day

2012-07-20T12:37:49Z

Designed by personal trainer Marco Mandic, the workout is a series of exercises that can be done without any equipment or special sports gear in any of Travelodge's 510 hotels. Customers can either download a free five minute work out video tape ...

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Women Worry That They Are Fat Three Times A Day

2012-07-20T11:11:55Z

Credit Suisse (Eur) Form 8.5 (EPT/NON-RI) - Glencore International plc

2012-07-18T18:23:47Z

Purchases and sales Class of relevant security Purchase/sale Number of securities Price per unit Ordinary shares S 2757 319.35 Ordinary shares S 247 319.30 Ordinary shares S 510 319.20 Ordinary shares S 7084 319.10 Ordinary shares S 1141 319 ...

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With Cain in mind, Phillies expected to offer Hamels about $130M for 6 years

2012-07-18T13:58:56Z

The Phillies are sending signals that they are planning to make an initial offer to star lefthanded pitcher Cole Hamels for about $130 million over six years within the next few days, sources familiar with the team's thinking told CBSSports.com. The ...

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Medical Device Daily Wins Prestigious SIPA Award for Outstanding Business Journalism

2012-07-16T11:45:18Z

AHC Media's Medical Device Daily, announced today that its report titled "Medical Device Daily's 510(k) Regulatory Pathway: How Coming Changes From the FDA May Profoundly Transform the Med-Tech Sector," won a coveted award from the Specialized Information

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Medical Device Daily Wins Prestigious SIPA Award for Outstanding Business Journalism

2012-07-13T15:23:36Z

Medical Device Daily Wins Prestigious SIPA Award for Outstanding Business Journalism

2012-07-13T13:00:26Z

Olea Medical Wins FDA 510(k) Clearance for Olea Sphere Medical Imaging Software

2012-07-12T19:56:48Z

The result of our investment in teaming with Emergo Group was that we got our 510(k) clearance without delays.” “The FDA’s 510(k) premarket notification process can be complex and labor-intensive for US-based as well as foreign manufacturers alike ..

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ABMC Announces Signing of Consent Decree Related to Its OralStat(R) Product

2012-07-10T08:31:59Z

the Company's 510(k) submission results in FDA's determination that the product is not substantially equivalent. For more information on American Bio Medica Corporation or its products, please visit www.abmc.com . About American Bio Medica ...

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Thomas Robinson, Tyshawn Taylor Selected In NBA Draft

2012-06-28T23:33:50Z

Robinson set a Kansas single-season record and led the nation with 27 double-doubles and his 463 rebounds were second only to former KU legend Wilt Chamberlain's 510 boards in 1956-57. His 11.9 rebound average was second in NCAA Division I in 2011-12.

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Prominent Metal-on-Metal Hip Implant Attorney Dismayed by Statements from DePuy …

2012-06-28T19:59:05Z

According to Parker Waichman LLP, the majority of metal-on-metal hip replacement devices used in total hip replacements were cleared for sale through the FDA's 510(k) protocols, which allows manufacturers to forgo human testing if they can show a device is

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FDA Advisory Panel Wrestling with Metal-on-Metal Hip Replacement Safety

2012-06-28T11:30:51Z

all-metal hips used in total hip replacement are eligible for the FDA’s 510(k) clearance process, which does not require human testing if it can be shown a device is substantially similar to a predicate product. However, some metal-on-metal ...

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Excelsior Medical Corporation retracts false statements, settles case with Ivera Medical

2012-06-27T05:19:48Z

Curos, manufactured in Carlsbad, CA, is the first disinfecting cap to be marketed in the U.S. and has received FDA's 510(k) market clearance. For more information about Curos and Ivera Medical, visit the website at www.curos.com.

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FDA Advisors Set to Examine Metal-on-Metal Hip Implant Safety Concerns

2012-06-26T13:27:45Z

As we’ve reported previously, most metal-on-metal hip implants sold in the U.S. were approved via the FDA’s 510(k) process, which doesn’t require human testing. According to a report from the Associated Press, lab tests indicated that ...

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Credit Suisse (Eur) Form 8.5 (EPT/NON-RI) - Glencore International Plc

2012-06-26T09:10:03Z

Credit Suisse (Eur) - Form 8.5 (EPT/NON-RI) - Glencore International Plc RNS Number : 1616G Credit Suisse Securities (Eur) Ltd 26 June 2012 FORM 8.5 (EPT/NON-RI) PUBLIC OPENING POSITION DISCLOSURE/DEALING DISCLOSURE BY AN EXEMPT ...

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For ballroom dance master, it's 510 performances at Tampa competition

2012-06-23T19:29:14Z

TAMPA — It was 6:45 a.m. Saturday when Sergey Barsukov walked into the ballroom at the Marriott Waterside hotel. His dance card was full. He'd been here until 9 p.m. Friday, 14 hours after his first number on day four of the Millennium ...

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Defective Medical Device Lawyer Says FDA User Fee Bill Fails to Fix Approval Problems

2012-06-23T14:07:06Z

Derek H. Potts of The Potts Law Firm, LLP, says the measure passed by the House this week should have closed a loophole in the FDA’s 510(k) approval process that has allowed potentially unsafe medical devices to reach the U.S. market. Kansas City ...

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Defective Medical Device Lawyer Says FDA User Fee Bill Fails to Fix Approval Problems

2012-06-23T08:02:02Z

Bacon -- finally, an incentive to eat ice cream

2012-06-22T15:34:11Z

“For someone watching their weight or concerned about heart disease, it takes away a big chunk of their recommended daily needs,” Love said of the sundae’s 510 calories and 670 milligrams of sodium — about a fourth of what the average ...

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Elekta's Agility Radiation Therapy Beam-shaping Innovation for Cancer Treatments Receives U.S. 510(k) Clearance

2012-06-22T11:30:48Z

ATLANTA, Jun 22, 2012 (PR Newswire Europe via COMTEX) -- - Utilizing new and faster technology, Agility multi-leaf collimator (MLC) expected to further improve therapy for oncology patients, accelerate treatment times ATLANTA, June 22, 2012 ...

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Elekta's Agility Radiation Therapy Beam-shaping Innovation for Cancer Treatments Receives U.S. 510(k) Clearance

2012-06-22T08:53:19Z

ATLANTA, June 22, 2012 /PRNewswire/ -- Using a combination of 160 high-resolution tungsten leaves and dramatically faster leaf movement, Elekta's revolutionary new Agility™* MLC promises a new level of precision and delivery speed in radiation therapy

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Work on PPL's $510M Susquehanna-Roseland power line work to begin in mid-July

2012-06-21T06:02:43Z

Preconstruction work on the $510 million Susquehanna-Roseland power line is expected to begin in Lackawanna and Luzerne counties in mid-July. Builders of the 101-mile line, PPL Electric Utilities, said the early work along the route will first ...

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Work on PPL's $510M Susquehanna-Roseland power line work to begin in mid-July

2012-06-20T15:22:15Z

Pre-construction work on the $510 million Susquehanna-Roseland power line is expected to begin in Lackawanna and Luzerne counties in mid-July. Builders of the 101-mile line, PPL Electric Utilities, said the early work along the route will first ...

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Work on PPL's $510M Susquehanna-Roseland power line to begin in mid-July

2012-06-20T15:15:05Z

Pre-construction work on the $510 million Susquehanna-Roseland power line is expected to begin in the Lackawanna and Luzerne counties in mid-July. Builders of the 101-mile line, PPL Electric Utilities, said the early work along the route will ...

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Work on PPL's $510M Susquehanna-Roseland power line to being in mid-July

2012-06-20T09:17:10Z

Bacon sweets going mainstream

2012-06-20T04:38:00Z

Burger King’s bacon sundae invaded our drive-thrus last week. It’s 510 calories of vanilla soft serve, fudge, caramel and bacon crumbles garnished with a bacon-strip swizzle stick, of sorts. The savory-sweet, crunchy-creamy, pork-and-ice ...

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Medical device intended to help women could be dangerous

2012-06-17T19:57:49Z

So why in the world would these mesh products be allowed on the market? Because of a loophole in the FDA's 510(k) approval process. According to a report by the Institute Of Medicine -- a moderate-risk device that is substantially equivalent to any ...

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Alabama Mike's singing the blues full time

2012-06-10T10:40:37Z

I can't take no licks like that." {sbox} East Oakland Boxing Association Benefit: 8 p.m. Tuesday. $30. Yoshi's, 510 Embarcadero W., Oakland. (510) 238-9200. www.yoshis.com.

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National Transvaginal Mesh Law Firm Announces That Johnson & Johnson’s Ethicon Inc. Will Halt Sales of Four Gynecare Transvaginal Products

2012-06-06T16:21:48Z

Though no formal vote was taken, the majority of outside medical experts on the panel backed the FDA's proposal to reclassify transvaginal mesh devices as high risk, which would make such devices ineligible for the agency's 510(k) protocols. In January ...

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FDA Must Strengthen Reviews For Risky Devices, FDA Head Says

2012-06-06T15:31:41Z

Asked by Law360 whether the surgical mesh case and others warranted a review of the FDA's 510(k) process, under which the mesh was approved, Hamburg told reporters that the FDA was considering ways to tighten its approval processes. “We have been taking

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National Transvaginal Mesh Law Firm Reports that Ethicon Inc. will Withdraw Four …

2012-06-05T11:08:01Z

FDA Clearance Process Misses Defective Medical Devices Report Finds

2012-06-01T04:31:54Z

Section 510(k) Process The investigation used information from the Government Accountability Office (GAO) and the Institute of Medicine, both of which had examined medical devices that made it to market via the FDA's 510(k) clearance process.

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John Cowen, poet, returns to Louie’s in Teaneck for a reading

2012-05-30T19:57:41Z

John Edwin Cowen, whose poetry reading from his first book, "Mathematics of Love," took place in January at Louie’s Charcoal Pit in Teaneck, will return to Louie’s, 510 Cedar Lane, Monday, June 18, from 5:30 to 7:30 p.m., to read from his recently ...

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Senate Passes FDA Safety And Innovation Act

2012-05-27T09:59:57Z

Under the FDA's 510(k) process, the agency has to approve a new device if it is substantially equivalent to one already being sold, even when the new device is based on one that has been recalled by manufacturers due to safety problems or has a recalled ..

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Weekender: This Weekend's Top Five Events

2012-05-25T10:09:29Z

You can hear all those raw materials in their songs, and the result is pretty satisfying. James Farm plays at Yoshi's (510 Embarcadero, Oakland) Friday through Sunday, May 25-27. Fri.-Sat. 8 p.m. and 10 p.m., Sun. 7 p.m.; $13-$30. Yoshis.com ...

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Senate Passes FDA Safety And Innovation Act

2012-05-25T06:49:03Z

Senate Bill Makes Some Improvements to Medical Device Oversight

2012-05-25T06:49:03Z

Under the FDA’s 510(k) process, the agency has to approve a new device if it is substantially equivalent to one already being sold, even when the new device is based on one that has been recalled by manufacturers due to safety problems or has a recalled

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Senate Passes FDA Safety And Innovation Act

2012-05-24T16:51:32Z

2012 Jaguar XFR

2012-05-23T19:58:50Z

The longest straightaway provided a top speed of just over 100 mph, and it was followed by a 180-degree turn. The Jaguar’s 510 horsepower would pin me back in the seat, and brakes erased speed with amazing ease when it was time to approach the turn.

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Strawberry picking season gets an early start

2012-05-21T10:42:52Z

"The berries are definitely early. I've never picked this early before," Fitz said. Pick-your-own strawberries begins on Wednesday at Fitz's, 510 Windsor Road. Early pickers: At the Charles Ilyes Family Farm, a small crowd formed on Saturday ...

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Hiding in Plain Sight: Why Every Employment Lawyer Should Know About ERISA Section 510

2012-05-11T03:30:54Z

3d 794, 798 (6th Cir. 1997) (quotation omitted). [6] Inter-Modal Rail Employees Ass'n v. Atchison, Topeka and Santa Fe Railway Co., 520 U.S. 510 (1997); Coomer, 370 F.3d at 509, n.8. [7] Smith v. Hinkle Mfg., Inc., 36 Fed. Appx. 825, 828 (6th Cir.

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DePuy ASR Metal-on-Metal Hip Replacement Recipient Ready to Give FDA an Earful

2012-05-10T19:59:56Z

Like many metal-on-metal hip implants, the DePuy ASR hip replacement device was approved through the agency’s 510(k) clearance protocols, which does not require human clinical trials. Next month, when Lorenz testifies at a meeting of the FDA ...

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Mesh Misery: Thousands are suffering. Where are the watchdogs?

2012-05-08T19:55:09Z

Basically, the public has been the guinea pig on this." He attributes this to a loophole in the FDA's 510 (K) approval process. According to a report by the Institute of Medicine, a moderate-risk device that is substantially equivalent to any ...

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UNITED STATES v. HUITRON GUIZAR

2012-05-06T19:57:31Z

Demore v. Kim, 538 U.S. 510, 522, 123 S.Ct. 1708, 155 L.Ed.2d 724 (2003). Mr. Huitron–Guizar cannot meet his burden of showing that there is no rational relationship (more below) between the classification and a legitimate government end. Equal ...

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A closer look at sex offenders

2012-05-05T11:51:56Z

However, for sake of argument, let’s use Mr. Johnson’s 5.3 percent figure; this statistic reveals that 1 in 20 of North Idaho’s 510 registered sex offenders will commit another sex offense. Some people may be willing to tolerate this level ...

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A closer look at sex offenders

2012-05-05T02:47:55Z

However, for sake of argument, let's use Mr. Johnson's 5.3 percent figure; this statistic reveals that 1 in 20 of North Idaho's 510 registered sex offenders will commit another sex offense. Some people may be willing to tolerate this level of ...

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Musical Performance Listings for May 3

2012-05-03T19:10:58Z

(435) 647-1940. WASATCH WINDS -- Performs "Let's Dance." 7:30 p.m. May 21. American Fork H.S., 510 N. 600 East, American Fork. $3. (801) 330-2186. "THE MIKADO" -- BYU School of Music presents two-act comic opera by Gilbert/Sullivan. 7:30 p.m. June 6-9.

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FDA Working on Barcode System to Track Medical Device Failures

2012-04-26T13:35:40Z

For devices like metal-on-metal hip implants like the DePuy Orthopaedics ASR and Pinnacle models, most transvaginal mesh devices, and faulty cardiac defibrillator leads, their approval through the agency’s 510(k) fast-track approval system has ...

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Musical Performance Listings for April 26

2012-04-26T03:05:45Z

600 South, Salt Lake City. $5. sharoniama@aol.com. WASATCH WINDS -- Performs "Let's Dance." 7:30 p.m. May 21. American Fork H.S., 510 N. 600 East, American Fork. $3. (801) 330-2186. VOCAL ACADEMY -- Week-long vocal summer camp for ages 15-25.

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Ivera Medical Announces the USPTO Upheld Key Patents for Disinfecting Port Protector Technology

2012-04-24T05:02:39Z

Jaguar rolls out the Ultimate XJ in China

2012-04-23T02:47:50Z

All that gear is set in motion by Jaguar's 510-horsepower supercharged V8, riding on an adjusted suspension and 20-inch wheels. While the Chinese market may be the target for luxed-out limos like this one, the XJ Ultimate isn't exclusive to China.

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Johnson & Johnson Transvaginal Mesh Class Action Lawsuit Filed in Canada

2012-04-19T09:40:36Z

In the U.S., most of the transvaginal mesh devices currently on the market were cleared through the agency’s 510(k) fast-track approval process, which grants access to the market without much pre-market safety testing, based on the idea that ...

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Musical Performance Listings for April 19

2012-04-19T02:52:34Z

Bombardier’s Q400 faces dogfight for WestJet fleet order

2012-04-18T19:21:36Z

He also pointed out that the Q400’s maximum cruising speed of 667 kilometres an hour outpaces its rival’s 510 km an hour. Some analysts, including Walter Spracklin at RBC Dominion Securities Inc. and Cameron Doerksen at National Bank Financial Inc ...

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The Globe and Mail

2012-04-18T19:21:36Z

Food Safety in the US: We're on Red Alert

2012-04-15T14:24:31Z

The United States once had one of the safest food systems in the world, but now, 70 million Americans are sickened, 300,000 are hospitalized, and 5,000 die from food-borne illness every year. It is a sad fact: since 9/11, far more Americans have been ...

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The contorted contours of Congressional power according to the radical Roberts Court

2012-04-15T12:58:37Z

Seven Cases v. United States, 239 U.S. 510, 514; Hamilton v. Kentucky [p148] Distilleries & Warehouse Co., 251 U.S. 146, 156. [Emphasis supplied.] If Justice Kennedy seeks the overturn of Carolene Products, he should forthrightly say so.

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Meshie Survival Foundation

2012-04-15T08:05:07Z

The FDA’s 510(k) clearing process is presently under scrutiny by several organizations including the Institute of Medicine. At the request of the FDA, the highly respected Institute of Medicine (IOM) independent 22 month study revealed that ...

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Proposed ‘Natural Health Products Bill’ in New Zealand would fine individuals $50,000 for making a cup of unapproved herbal tea

2012-04-10T06:16:31Z

The health freedom of New Zealanders is under very serious threat, as the federal government there pushes to pass a bill known as the Natural Health Products Bill (NHPB), or Bill 324-1, that will bring the nation into compliance with the overbearing and .

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They are who we thought they were: The extreme and radical Republican Party

2012-04-08T10:58:04Z

Society of Sisters, 268 U.S. 510, or national, Meyer v. Nebraska, 262 U.S. 390; Bartels v. Iowa, 262 U.S. 404; Farrington v. Tokushige, 273 U.S. 284, or racial minorities, Nixon v. Herndon, supra; Nixon v. Condon, supra: whether prejudice ...

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Most Medical Implants Are Not Tested Before Market: Report

2012-04-03T10:28:12Z

Consumer Reports released an investigative report on dangerous medical devices, focusing on the FDA’s 510(k) approval process, which allows medical device manufacturers to pay a $4,000 fee and begin selling untested medical implants like artificial hips

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Toxic mine gas sparks work suspension

2012-04-01T17:47:14Z

Spokesman Alex Smith says some of the mine's 510-strong workforce have succumbed to poisonous gases in the site's longwall mines. "The most abundant gases are carbon monoxide and sulphur dioxide, sulphur dioxide being the most irritant of them," he said.

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FDA’s 510(k) gets tougher, more predictable

2012-03-29T00:32:50Z

SAN JOSE, Calif. – The U.S. Food and Drug Administration has become tougher but more predictable in how it handles medical products seeking approval under its 510(k) process, said a consultant at the DesignMed conference, part of the Design ...

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Parker Waichman LLP Warns that Johnson & Johnson Marketed Gynecare Prolift Transvaginal Mesh Device for Three Years Before FDA Granted Approval

2012-03-27T15:08:31Z

Alonso Krangle LLP Disturbed by Report that DePuy Phased Out ASR Hip Implants After FDA Request for Data on ASR Failure Rates

2012-03-27T13:28:18Z

was approved in 2005 through the FDA’s 510(k) process, which doesn’t require human clinical trials if the design of a device is substantially equivalent to another already approved for sale by the agency. However, since hip resurfacing constituted a ..

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Integra Reports 510(k) Clearance From FDA For Laparoscopic Instruments Range

2012-03-26T06:05:40Z

(RTTNews) - Integra LifeSciences Holdings Corp. (IART: News ) Monday reported receiving the US Food and Drug Administration's, or FDA's, 510(k) clearance for its new range of Jarit Take-it-Apart Laparoscopic Instruments. The company added that the product

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Vancouver's Vision Critical continues swift rise to the top

2012-03-19T02:39:14Z

ft new space, which will involve plenty of wood panelling and a minigolf course set into the office floor. The average age of the company's 510-person workforce is about 28. It's a generation that values creative space to inspire innovation, says Reid ...

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Pressure Building to Revamp FDA Medical Device Approval Process

2012-03-15T10:00:38Z

Concern and consternation continues to rise over the FDA’s 510(k) fast-track medical device approval process, which only requires that a new medical device be substantially equivalent to an existing device before being sold to, or implanted in ...

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Parker Waichman LLP Calls on the U.S. Congress to Act Now to Address the Serious Public Health Threat Posed by Metal-on-Metal Hip Implants

2012-03-15T03:48:24Z

According to the British Medical Journal, most of the metal-on-metal hip implant devices currently on the market were approved through the FDA's 510(k) clearance protocols, which do not require human studies if a device is shown to be similar to another ..

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Parker Waichman LLP Calls on the FDA to Act Now to Address the Serious Public Health Threat Posed by Metal-on-Metal Hip Implants

2012-03-14T16:35:31Z

[mhra.gov.uk/NewsCentre/Pressreleases/CON143784, britishhipsociety.com/MoM%20Update.htm] According to the British Medical Journal, most of the metal-on-metal hip implant devices currently on the market were approved through the FDA's 510(k) clearance ...

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Shares of Antares Pharma and Boston Scientific on the Upswing -- Medical Equipment and Supplies Indu

2012-03-14T05:08:19Z

According to Bloomberg, the debate centers on the agency's 510(k) program, which is used to clear 90 percent of medical products in the U.S. each year. The process can allow devices on the market without human testing if the FDA deems them "substantially .

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Moreland residents beat police

2012-03-11T14:44:33Z

Coburg personal trainer and event organiser Archie Basil said the community team managed 548 push-ups in 90 seconds, compared with the Fawkner police team’s 510, at the February 25 event in Coburg. Proceeds will go to the Make-a-Wish Foundation.

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More Regulation Looms for the Medical Equipment and Supplies Industry

2012-03-08T10:49:09Z

BG Medicine Announces Fourth Quarter and Full Year Fiscal 2011 Results

2012-03-08T05:12:42Z

We are working with the FDA on the Company's 510(k) for CardioSCORE with a goal of obtaining FDA clearance by year end. -- We are focused on the pre-launch market development and our commercialization strategy for CardioSCORE. We plan to ...

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New display at Army Air Field Museum; good job by 911 Center; drug treatment; BEN Column, March 7, update 2

2012-03-07T17:31:12Z

Chance of arresting drug dealers to end drug use: None. And we have a criminal ceiling in Cumberland County. It’s 510 inmates in the county jail. After that, it’s show up for your hearing. What do you do while waiting for your hearing?

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Shares of Antares Pharma and Boston Scientific on the Upswing -- Medical Equipment and Supplies Industry Soaring in 2012

2012-03-06T23:51:46Z

MedTech Industry Stock Outlook - March 2012

2012-03-06T15:23:32Z

The guidance offers greater clarity and transparency on the regulatory framework, policies and practices underlying the agency’s 510(k) review process. The primary aim of the guidance is to elucidate certain key points (outlined in a decision ...

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More Regulation Looms for the Medical Equipment and Supplies Industry

2012-03-06T08:42:40Z

Shares of Antares Pharma and Boston Scientific on the Upswing -- Medical Equipment and Supplies Industry Soaring in 2012

2012-03-06T08:14:02Z

Parker Waichman LLP Warns that Thousands of Metal-on-Metal Hip Implant Patients Face Risk of Serious, Long-Term Health Problems

2012-03-05T03:14:34Z

In the U.S., most of these devices were eligible for the FDA's 510(k) clearance protocols, which do not require human studies if a devices is shown to be similar to another already on the market. Many manufacturers changed the design of their metal hips ..

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FDA regulator wants more power over medical devices

2012-03-03T09:14:51Z

The debate centers on the agency’s 510(k) program, the system used to clear 90 percent of medical products in the United States each year. The process can allow devices on the market without human testing if the FDA deems them “substantially ...

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Rubicon Genomics Selects Velesco to Manufacture its TransPLEX® RNA Amplification Kits for Clinical Diagnostic Use

2012-03-02T17:37:07Z

cGMP production of the TransPLEX kits is required as part of the FDA's 510(K) clearance process for the Symphony tests. "We are pleased to be able to provide high quality cGMP manufacturing services to Rubicon as they expand into the clinical ...

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FDA Device Chief Says Approval ‘Loophole’ Needs to Be Closed

2012-02-29T06:40:56Z

Approval Program The debate centers on the agency’s 510(k) program, the system used to clear 90 percent of medical products in the U.S. each year. The process can allow devices on the market without human testing if the FDA deems them ...

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FDA Official Says Agency Needs More Authority on Medical Device Approvals

2012-02-28T14:13:05Z

A number of the more recent medical devices to reach the U.S. market were approved through the FDA’s 510(k) “fast-track” approval system. This allows a manufacturer to get a new product to the public with minimal pre-market safety testing.

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Medical Device Companies Fight FDA Safety Improvements: Report

2012-02-28T09:26:46Z

Many moderate and high-risk medical devices get through to the market with virtually no required testing by using the FDA’s 510(k) fast-track approval process, which only requires that the device be “substantially equivalent” to an existing device ..

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Recalled DePuy Hip Implants Sold Overseas Were Rejected by FDA

2012-02-16T12:39:57Z

Johnson & Johnson also faces over 900 DePuy Pinnacle hip lawsuits filed by individuals who have experienced problems with the older metal-on-metal hip replacement, which was used to gain approval for the ASR hip implant under the FDA’s 510(k) process.

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Parker McDonald Law Firm Examines Bill Aimed at Blocking Medical Devices Tied to Recalls

2012-02-09T16:30:09Z

Companies rely heavily on the FDA’s 510(k) process to ensure that their product will hit the market as soon as possible without the costs of conducting clinical trials. This fast-paced approach used by manufacturers has come under review in recent years.

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The Globe and Mail

2012-02-08T18:40:12Z

The maximum cruising speed of the Q400 is 667 kilometres an hour, compared with the ATR plane’s 510 km/h, WestJet added. Mr. Saretsky confirmed the two plane manufacturers on WestJet’s shortlist after the carrier announced that its quarterly dividend .

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The Globe and Mail

2012-02-08T18:40:12Z

The Globe and Mail

2012-02-08T18:40:12Z

Democrats Want to Let FDA Block Devices Tied to Recalls

2012-02-08T03:09:37Z

The devices were cleared by the agency’s 510(k) system, which allowed them to be sold without human testing once the FDA rules they are similar to existing products. In October, Bloomberg News reported many implants trace their approvals to a ...

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Democrats Want to Let FDA Block Devices Tied to Recalls

2012-02-06T06:53:54Z

Bill Would Block FDA 510(k) Approval For Medical Devices Associated With Recalls

2012-02-06T00:41:40Z

The devices were cleared by the agency’s 510(k) system, which allowed them to be sold without human testing once the FDA rules they are similar to existing products.” In support of the new legislation, House Democrats cited injuries stemming from ...

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Democrats Want to Let FDA Block Devices Tied to Safety Recalls

2012-02-06T00:05:52Z

They were cleared by the agency’s 510(k) system, which lets technologies reach the market without human testing if the agency deems them similar to existing products. In October, Bloomberg News reported many implants can trace their approvals ...

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Council proposes eliminating controversial wording

2012-02-03T05:53:02Z

The Blue Book's 510 states, “Transferring and enrolling in a school, in whole or in part, for athletic reasons may jeopardize a student's eligibility.” As many transfers could be viewed as being at least in part athletically motivated ...

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Democrats Want to Let FDA Block Medical Devices Tied to Safety Recalls

2012-02-02T16:16:59Z

Democrats Want to Let FDA Block Medical Devices Tied to Safety Recalls

2012-02-02T16:02:40Z

Carmel Fund Invests in California Company

2012-01-31T15:00:37Z

The results of the IDE Study will be used to support the company’s 510(k) application in the U.S. later this year. “We believe that AirXpander’s AeroForm tissue expansion system has the potential to provide hundreds of thousands of women ...

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Democratic Lawmakers Again Request Hearings on Transvaginal Mesh, Lap-Band Safety

2012-01-23T13:51:22Z

Transvaginal mesh devices were mostly approved through the agency’s 510(k) fast-track approval process, which grants access to the market without much pre-market safety testing, based on the idea that the products were similar in design to a ...

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House Democrats Seek Congressional Hearings on Vaginal Mesh Safety

2012-01-21T11:44:53Z

Specifically, lawmakers are concerned that the FDA’s 510(k) fast-track approval system may allow potentially defective devices to reach the market. The U.S. Food and Drug Administration recently ordered 33 companies, including Johnson & Johnson ...

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Abortion - Round Two

2012-01-20T11:46:04Z

Oklahoma, 316 U.S. 535; the liberty to direct the education of one's children, Pierce v. Society of Sisters, 268 U.S. 510, and the privacy of the marital relation, Griswold v. Connecticut, supra, are in this category.4 [410 U.S. 213] Only last ...

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Ivera receives new FDA clearance for Curos disinfecting port protector

2012-01-18T04:46:06Z

The FDA's 510(k) clearance of Curos is a pivotal step in that direction, and reinforces Ivera's commitment to providing higher-quality and innovative solutions to our customers."

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In the Area (Jan. 16)

2012-01-16T01:06:34Z

Music by Scott at the Parlor, 6 to 8 p.m., Tuesday, Diane's, 510 N. Bullard Street, , 510 N. Bullard St. Call for more information: (575)538-8722. Every Tuesday. register for WILL courses and Institute for Foreign Language Study (IFLS ...

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United States: FDA Issues Draft Guidance Mapping 510(k) Review Process

2012-01-12T06:11:58Z

and practices underlying FDA's 510(k) review." When finalized, the draft Guidance will replace two prior Guidance documents on the same subject, "Guidance on the CDRH Premarket Notification Review Program, 510(k) Memorandum K86-3," issued on June 30 ...

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In the Area (Jan. 9)

2012-01-09T00:31:55Z

Hwy. 180, Silver City. Second and fourth Tuesdays. Music by Scott at the Parlor, 6 to 8 p.m. Tuesday, Diane's, 510 N. Bullard St., Silver City. Every Tuesday. For more information, call: (575) 538-8722. Wednesday Grant County Democratic Party ...

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In the Area (Jan. 10)

2012-01-08T18:55:29Z

Hwy. 180, Silver City. Second and fourth Tuesdays. Music by Scott at the Parlor, 6 to 8 p.m. today, Diane's, 510 N. Bullard St., Silver City. Every Tuesday. For more information, call: (575) 538-8722. Wednesday Grant County Democratic Party ...

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Big Names Join Clinical Proteomics Push in 2011, Offering Ray of Optimism Amidst Difficult Year

2012-01-06T13:57:12Z

Mass spectrometers are exempt from FDA’s 510(k) approval process, but, noted Mya Thomae, CEO of IVD regulatory consulting firm Myraqa, they still would need to be registered under the agency’s quality systems regulation to be used for clinical proteomi

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FDA Orders Safety Studies for Vaginal Implants Made By J&J and C.R. Bard

2012-01-05T18:16:05Z

“Our goal is to make sure the right women use it at the right time.” The meshes were approved through the FDA’s 510(k) system, which allows products to reach the market without human testing if the agency decides they’re similar to ...

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LipoScience Submits FDA 510(K) for Vantera® Clinical Analyzer

2012-01-05T08:57:45Z

Today, the NMR LipoProfile test is performed only in LipoScience’s CLIA-certified laboratory. “Today’s 510(k) submission is an important step toward our objective to decentralize our technology platform and extend the reach of the NMR ...

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Crime Blotter: Vehicle, Home Burglaries

2012-01-05T07:10:22Z

currency. 6:01 AM – A vehicle burglary occurred at the 24Hr. Fitness, 2180 N. Lincoln Av. Suspect described as a male, Hispanic, mid 20’s, 510-600, athletic build, black hair. The suspect was startled by the victim upon being observed leaning into the

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In the Area (Jan. 2)

2012-01-02T00:54:32Z

College Ave., Silver City. For more information, call: (575) 574-2724. Music by Scott at the Parlor, 6 to 8 p.m. every Tuesday at Diane's, 510 N. Bullard St., Silver City. For more information, call: (575) 538-8722. Wednesday Insight Meditation ...

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Transvaginal Mesh Attorney Supports Federal Lawmakers’ Efforts to Improve Monitoring of Medical Devices

2011-12-30T14:26:59Z

“The problem is that too many defective and dangerous medical devices make it to the market in the first place under the FDA’s 510(k) process because they are never demonstrated to be safe or effective before being cleared for sale,” said ...

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Transvaginal Mesh Attorney Supports Federal Lawmakers’ Efforts to Improve Monitoring of Medical Devices

2011-12-30T12:39:36Z

Hip Implant Manufacturers Target of Congressional Probe

2011-12-26T01:02:50Z

Specifically, the legislation is designed to track those devices which are approved under the U.S. Food and Drug Administration’s 510(k) rule. This system allows for a streamlined approval process in which medical device manufacturers are only required .

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NextEra Wisc. Point Beach 1 reactor up at 28 pct-NRC

2011-12-19T14:32:52Z

Dec 19 (Reuters) - NextEra Energy Inc's 510-megawatt Unit 1 at the Point Beach nuclear power plant in Wisconsin ramped up to 28 percent power by early Monday from 14 percent power Friday, the U.S. Nuclear Regulatory Commission said in a report. The Unit ..

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Senators Question Medtronic on Infuse Side Effects

2011-12-19T09:03:35Z

As we reported last week, the same group of Senators has introduced a bill that would require medical device companies to track side effects come to market for any device subject to the U.S. Food & Drug Administration’s 510(k) approval process.

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Letters to the Editor - Dec. 18

2011-12-18T02:59:42Z

If another company then develops a "substantially equivalent" product it must go through the FDA's 510(k) process, which is much shorter and less expensive, but still requires safety and clinical testing. How does the regulatory approval process ...

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Letters to the Editor - Dec. 18

2011-12-18T02:59:42Z

Senators Introduce Bill to Track Medical Devices Cleared Through FDA’s 510(k) Process

2011-12-15T11:45:49Z

A bipartisan bill just introduced in the U.S. Senate would require the makers of some implantable medical devices to track their performance after they are approved for sale. The bill, sponsored by two Democrats, Herb Kohl of Wisconsin and ...

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Hansen Medical Inks $30M Debt Financing

2011-12-09T08:25:20Z

provides the company with a strong cash position as we begin the commercialization of our Magellan™ Robotic System in Europe and anticipate the Magellan’s 510(k) clearance and initial launch in the US in the second quarter of 2012.” The facility ...

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Wright Conserve Hip Replacement Lawsuit Filed Over Design Problems

2011-12-07T11:26:40Z

The Conserve hip implant was approved through the FDA’s 510(k) fast-track program, which meant that the company only had to show that the implant was substantially equivalent to a product already on the market. This allowed the company to skip extensive

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Tyrannical "Health Standards" Of The New World Order

2011-12-07T01:00:00Z

...if all this doesn’t sound eerily familiar. It certainly does to me. Last year, when the United States Congress was busy passingS.510, a bill that was very similar if not identical in scope to the New Zealand Food Bill, we heard the same cat calls

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ALung planning European launch of artificial lung system

2011-11-30T18:58:47Z

ALung is currently in discussions with U.S. authorities to determine the proper regulatory path for the HemoLung — specifically whether it’ll proceed through the U.S. Food and Drug Administration’s 510(k) or Premarket Approval Application ...

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Applied Medical Technology gets FDA clearance for feeding tube

2011-11-30T12:03:36Z

Cleveland area AMT’s “Low-Profile Transgastric-Jejunal Feeding Tube Kit” was listed among the FDA’s 510(k) clearances for October. Company official Dr. George Picha didn’t return a call seeking comment. The jejunum, which is referenced ...

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Brand New Firmware for Adata's S510 and S511 SSD Drives

2011-11-30T01:55:09Z

Good news for all Adata SSD users: new firmware has been released for the S510 and S511 drives, no matter whether you have the small 60GB ones, or the hefty 480GB versions. All the S510/ 511 series has received improved firmware which promises better ...

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Just another brick in the wall: UN Agenda 21 in US law

2011-06-19T01:00:00Z

...bail out homeowners? No! We bailed out the thugs and thieves! Now here is where we start putting the puzzle pieces together: S.510 fake food safety bill will destroy independent agriculture and export most of our food product out of the country. (ou

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In partial victory against GMOs, U.S. Congress bans FDA from approving GM salmon

2011-06-16T01:00:00Z

...it needs to operate. This is why the FDA is constantly trying to expand its budget through deceptive legislation efforts such as the S.510 Food Safety Bill. Every corrupt (evil) federal agency always wants more money so that it can have more power and a

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FDA victory in the War on Raw Milk!

2011-05-01T01:00:00Z

...December 21, the U.S. House of Representatives passed H.R. 2751, the “FDA Food Safety Modernization Act” (formerly S.510). On Sunday night, December 19, the Senate passed FSMA by unanimous consent without a recorded vote after substituting its langu

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With superbugs contaminating fresh meat, the truth comes out about the FDA Food Safety Bill

2011-04-16T20:00:00Z

...Remember all the hubbub about the S.510 "Food Safety Bill" and how it would make your food safe to eat? Well, it turns out those expanded FDA powers do absolutely nothing to even address the safety of fresh meat products, and yet new research reveals th

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Sidley Austin LLP > Senate Passes Food Safety Legislation Food Product and ...

2011-03-08T19:00:00Z

Although S. 510 was passed with significant bipartisan support (73-25), it was opposed by some interested parties on the ground that it would, if enacted as written, increase the burden of regulation and potentially raise food prices. ...

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