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The Food and Drug Administration is asking the government's top medical advisers to review its system for approving certain types of medical devices, which has been criticized by safety advocates and government watchdogs.
The Food and Drug Administration is awarding $2 million to spur the development of medical devices for children, who face increased risks during surgery because so few implants are designed for their use.
The medical device industry is trying to rein in a growing number of TV and magazine advertisements for hip replacements and other implants, amid congressional scrutiny of the marketing push.
Some medical devices for sensitive uses, from certain hip joints to a type of defibrillator, have won government approval without a close scientific review, congressional investigators said Thursday.
A consumer watchdog group on Wednesday questioned the legality of several advertisements for medical devices that appear on YouTube and called on regulators to crack down on the promotions.
Medical experts told lawmakers Wednesday that new television advertisements for medical devices pose even greater risks to patients than ads for drugs, which have been scrutinized for years.
The hips and knees are synthetic, but it's real money changing hands. Five makers of artificial joints have paid more than $200 million this year to doctors and hospitals, often the same ones who are deciding which company's joints to buy, according to an Associated Press calculation of disclosures required this week by a settlement with federal prosecutors.
Colorado-based Spectranetics Corporation to Pay $5 Million to Resolve Allegations Relating to Its Medical DevicesSpectranetics Corporation, a medical device manufacturer, has agreed to pay the United States $4.9 million in civil damages plus a $100,000 forfeiture to resolve claims against the company, the Justice Department announced today.
Old, Brutal Surgeries Inspire Elegant Modern Devices | Wired Science from Wired.comBy combing through old scientific journals, medical-device companies are finding effective, but brutal treatments for common diseases that could be transformed by modern technology into safer, noninvasive procedures.
FDA Scientists Complain to Obama of Corruption [in medical devices review division]Wow! This is seriously SCARY! AP: Washington - In an unusually blunt letter, a group of federal scientists is complaining to the Obama transition team of widespread managerial misconduct in a division of the Food and Drug Administration.
FDA scientists complain to Obama of 'corruption'By RICARDO ALONSO-ZALDIVAR Associated Press Writer Published: Thursday, Jan. 08, 2009
F.D.A. Scientists Accuse Agency Officials of Misconduct"WASHINGTON — Top federal health officials engaged in "serious misconduct" by ignoring concerns of scientists at the Food and Drug Administration and approving for sale unsafe or ineffective medical devices, the scientists have written in a letter to Congress."
No Recourse for the InjuredConsumers are already at the mercy of the all-too-fallible Food and Drug Administration.
Justices Make It Tougher to Sue Medical Device MakersThe NYT reports: The 8-to-1 ruling in favor of Medtronic, the Minneapolis-based maker of cardiovascular devices, made it much more difficult for patients and their families to sue makers of medical devices that have been granted federal approval. ***
Agreement With China to Regulate Some DrugsBEIJING — American and Chinese regulators signed an agreement Tuesday to strengthen regulation of drugs and medical devices exported to the United States.
Senators Introduce Transparency in Medical Device Pricing Act of 2007On October 23, 2007, Senators Charles Grassley and Arlen Specter issued a Press Release announcing the introduction of the Transparency in Medical Device Pricing Act of 2007.
Sales of Stints, Syringes and Drugs, Drive Pharma Profits Beyond ExpectationsAs illness soars skyward, so does the revenue of the bio-pharma sector. No longer are syruinges limited to doctors, hospitals.
J&J exec steps down in wake of improper paymentsJohnson & Johnson said Monday it believed that non-U.S. subsidiaries had made improper payments in connection with the sale of medical devices in two small-market countries, and said its worldwide chairman of medical devices and diagnostics had retired.
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