FDA Gives Implanted Blood Access Devices Less Stringent Regulation
The Food and Drug Administration has deemed certain medical devices as being safer than they previously were. The agency has just released draft guidance which concerns a type of medical product known as an implanted blood access device. Such technology usually takes the form of cannulae, catheters, and hollow needles that work by placing a… read more
Oxygen Concentratros From Nidek Recalled Over Fire Hazard
A Class I recall, the most serious of all types of safety warnings, has been initiated on a medical device that could potentially harm consumers. The recall was announced by Nidek Medical Products and concerns their Nidek Medical Mark5 Nuvo Lite Oxygen Concentrators. 11 models of the product in total fall within the purview of… read more
FDA Calls Out Deficiencies in Sapien Heart Valve Clinical Trials
A new medical device is facing a potential hurdle following a Food and Drug Administration review that called into question the safety of the item. The product in question is the Sapien heart valve manufactured by Edwards Lifesciences Corporation. The Sapien is intended to be used as an alternative to surgery in order to correct… read more
FDA Asks Pfizer To Pull Misleading EpiPen Television Ad
The Food and Drug Administration is warning Pfizer that one of their ads has the potential to mislead consumers. The ad in question is used as marketing material for the company’s EpiPen and EpiPen Jr Auto Injectors. In the television ad that the FDA accuses of being misleading, a mother and a child are talking… read more
FDA Admonishes McNeil For Not Addressing Consumer Complaints
The Food and Drug Administration has some serious concerns about the safety procedures that a pharmaceutical giant has in place for handling complaints. The McNeil division of Johnson & Johnson has been the recipient of a warning letter from the safety agency. The FDA believes that this division failed to properly look into hundreds of… read more
Blood Loss Risk Prompts Moog to Recall Intravenous Medical Device
A medical device meant to provide intravenous medication to patients afflicted by a variety of conditions has been recalled because of a discovery that the items might not work correctly. The recall was announced by the Moog Medical Devices Group, a company based out of Salt Lake City, Utah. The product in question is the… read more
Heart Attack Detector Recalled For Not Meeting FDA Standards
A device that is used to detect whether a heart attack has taken place has been recalled because certain lots of the device fail to adhere to mandated guidelines. The Waltham, Massachusetts-based Alere Inc. announced the recall of their Alere Triage BNP, Alere Triage D-dimer, and Alere Triage cardiololoy panels. 104 lots in total are… read more
FDA Promotes Efforts to Keep Kids Safe from Drug Dangers
Because medications often react differently in adults and children, parents need to be aware of the risks and benefits of doling out certain drugs to their little ones. And the Food and Drug Administration wants to prepare adults with the information they need to ensure their children are safe. To that end, they’re promoting the… read more
CT Scans Come Under Fire in New FDA Proposed Guidelines
The Food and Drug Administration wants to crack down on the overuse of medical devices that they say might expose children to unnecessarily high amounts of radiation. Last week, the agency released a brand new set of proposed guidelines that would make devices such as CT scans safer for young children. Among other things, CT… read more
Officials Say Medical Devices Vulnerable to Hackers
We often think about how devastating a cyberattack or viral infection can be for our computers. But could similar tactics be used by hackers to compromise the safety of medical devices? The general consensus seems to be that such a hack is indeed possible, which is why the National Institute of Standards and Technology and… read more
