The Medical Device Business Journal — Medical Device News & Articles | MassDevice
Cambridge Heart Inc. (OTC:CAMH) won a much-needed nod from the Food & Drug Administration when the watchdog agency cleared an OEM version of its microvolt T-wave alternans cardiac monitor.
The 510(k) clearance means the Tewksbury, Mass.-based firm can move forward with a deal it struck last year with Cardiac Science Corp. (NSDQ:CSCX) to incorporate the MTWA device into Cardiac Science’s Q-Stress line of heart stress-testing equipment.
The Food & Drug Administration is looking to cut down on the number of accidental radiation overdoses by changing the way new radiation-emitting therapies make it to market.
The federal watchdog agency sent out a letter to manufacturers today, reporting that it received 1,200 reports between 1999 and 2010 about devices that deliver radiation treatments to cancer patients.
The Food & Drug Administration’s Center for Devices and Radiological Health saw a dramatic, 45 percent increase in complaints last year, logging a record high of 133 in 2009.
In total, the agency received 250 contacts during the year, a 41 percent increase from the previous high-water mark of 177 in 2007, according to the agency’s annual ombudsman’s report. The 2009 tally is also a record high for the agency, which first opened its ombudsman office in 2000.
The Food & Drug Administration will require medical device manufacturers to include information on the pediatric population that might be served by devices they’re seeking approval for from the agency.
The requirement, which was part of the Food & Drug Administration Amendments Act passed in 2007, applies even to devices intended for use in adults. The new rule is aimed at improving the identification of devices that could be used to treat children and at enhancing the agency’s ability to track those devices and devices approved for use in pediatric patients.
Federal investigators cleared Food & Drug Administration managers of criminal acts against agency scientists who opposed clearances given to some medical devices, according to the Wall Street Journal.
Anonymous scientists at the federal watchdog agency wrote open letters last year to Congress and President Barack Obama, citing "serious wrongdoing" by top FDA officials and asking Obama to clear house in the Center for Devices and Radiological Health.
Two weeks after hastily yanking its entire field inventory of implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators, Boston Scientific Corp. (NYSE:BSX) officials broke their silence in a series of conference calls with physicians.
BSX CEO Ramond Elliot said the company filed a 30-day notice with the Food & Drug Administration March 15 and 16 and confirmed reports that the FDA will not be expediting its review.
In its effort to improve tracking of medical device performance, the Food & Drug Administration’s Center for Devices and Radiological Health will hold a workshop at the end of April to engage academics in developing analytical tools for things like comparative effectiveness research.
The all day workshop, “Medical Device Epidemiology Network” or MDEpiNet, is slated for April 30 at the FDA’s White Oak campus in Silver Spring, Md.
Food & Drug Administration chief Margaret Hamburg defended the agency’s 23 percent budget increase request for 2011 before a senate panel March 10, saying that the $755 million boost was “crucial to the modernization” of the federal watchdog agency, which regulates nearly 20 percent of all products purchased and consumed in the United States.
In a mostly civil hour of testimony before a Senate appropriations subcommittee, Hamburg reiterated her talking points on the need for increased scrutiny of food, drugs and medical devices. It was her first time testifying before the appropriations committee since being sworn in eight months ago.
By Thomas Lee
Medtronic Inc.’s (NYSE:MDT) Activa deep-brain stimulation device failed to meet the major goals of a clinical study examining its use in treating epilepsy, according to Food & Drug Administration documents.
The Fridley, Minn.-based medical devices monolith’s study of the device, which sends a trickle of electric current to the anterior nucleus region of the brain, failed to demonstrate that patients using the device experienced less seizures than patients in the control group who did not receive the therapy, according to FDA documents.
The Food & Drug Administration warned a Salem, N.H.-based maker of guidewires used in catheters that its quality systems aren’t up to snuff.
Regulators made public March 10 a warning letter sent to Guidewire Technologies Inc., advising the company that they are in violation of three quality systems regulations that must be remedied.
The agency said in a Feb. 26 letter that the company is failing to test each production run to ensure the products have been sterilized and that the company’s Teflon guidewire coating process has not been validated. In addition, the agency said internal quality systems haven’t been audited since 2006.
Healthcare information technology designed to improve patient care might also be the cause of six deaths and hundreds of “adverse events,” a development that’s prompted the Food & Drug Administration to consider regulating the industry, according to a report by the Huffington Post Investigative Fund.
The website obtained advance testimony from newly-minted Center for Devices and Radiological Health chief Jeffrey Shuren, calling for a closer look at whether software programs should face similar regulatory hurdles as medical devices. Shuren is slated to testify before the Health Information Technology Policy Committee Feb. 25.
