The Medical Device Business Journal — Medical Device News & Articles | MassDevice
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Cardiac Science Corp. (NSDQ:CSCX) will replace 24,000 automated external defibrillators implicated in a November 2009 recall.
The Bothell, Wash.-based company’s Powerheart, CardioVive, Nihon Kohden and GE Responder AEDs have electrical component flaws that may cause device failures. The flaws could not be remedied through software patches, according to the Food & Drug Administration.
The Food & Drug Administration issued its final order for the U.S. recall of Baxter International Inc.’s (NYSE:BAX) Colleague infusion pumps.
The federal watchdog is requiring the Deerfield, Ill.-based company to provide transition guide for hospitals and clinics using Colleague infusion pumps.
The guide will include a list of FDA-cleared or approved pump alternatives and information on refund, replacement and lease termination programs, the regulatory agency said.
Medtronic Inc.’s (NYSE:MDT) headache over its Physio-Control Inc. subsidiary is turning into a veritable migraine, as it reveals another issue with its LifePak line of defibrillators.
Redmond, Wash.-based Physio-Control said it issued a "field correction" for some of its LifePak 20/20e defibrillators, after discovering that some of the devices might lose battery power while in operation.
The Food & Drug Administration’s Center for Devices and Radiological Health established a website to aid the the industry in understanding the Center’s Kafka-esque approval process.
The site, called CDRH Learn, consists of training modules designed to educate the public on pre-market and post-market medical device and radiological health regulation. The resource includes video presentations and an exam to assess each user’s knowledge of approval processes.
Dr. Jeffrey Shuren, head of the Food & Drug Administration’s medical device oversight arm, told a Massachusetts audience that results from the agency’s internal, soup-to-nuts review of its 510(k) clearance program are due out in a few weeks.
At the second in a series of "town hall" meetings in Woburn, Mass., the Center for Devices & Radiological Health’s leader said the federal watchdog would seek public comment on the report before making any changes to the program.
Shuren told MassDevice that the agency still hasn’t decided exactly what changes are in store for the 510(k) process.
The Food & Drug Administration plans to launch a public database of recall data this fall, another element in the agency’s quest to become more transparent.
The data, on recalls of medical devices, food products and drugs, will be compiled in a searchable, online database. The data will also be made available in a downloadable XML format.
The Food & Drug Administration wants the public’s help in figuring out whether its premarket approval process for medical devices is strict enough.
A pair of Minnesota legislators are lobbying against changes the Food & Drug Administration proposes for its 510(k) clearance protocol the industry says will hurt innovation and the state’s economy.
U.S. Sen. Amy Klobuchar (D:Minn.) and Rep. Erik Paulsen (R:Minn.) sent a letter to FDA Commissioner Dr. Margaret Hamburg, warning that overzealous regulation would hurt start-ups struggling to raise venture capital in a weak economy.
As part of its ongoing attempt to remove bureaucratic impediments from the development of medical devices, the Food & Drug Administration is planning a public workshop to address innovation in the medical device industry June 24 in Washington.
Boston Scientific Corp. (NYSE:BSX) garnered both a CE Mark and Food & Drug Administration pre-market approval for its NC Quantum Apex PTCA dilation balloon catheter.
The post-dilation device is designed to optimize coronary stent deployment; according to the company’s POSTIT study, the device improves the accuracy of stent deployment compared with a stent delivery balloon alone.
By Mary Vanac
X-spine Systems Inc. received 510(k) clearance from the Food & Drug Administration to sell its Fixcet spinal facet screw system.
Fixcet is used to stabilize the spine during spinal fusion procedures, such as treatment of degenerative disk disease, the company said in a press release. Facets are the wing-like bones on the backside of spinal vertebrae.
