MASSDEVICE ON CALL — Consumer groups are a frequent presence in discussions of medical device regulation, but one relative newcomer may have lost some points in its representation of how the industry operates in its regulatory environment.
Consumers Union, an advocacy arm of Consumer Reports, launched a charge for more stringent FDA oversight of the industry just over a year ago with its Safe Patient Project.
The group has been involved in recent regulatory discussions involving FDA user fees for the medical device industry and clearance status for Aptus Endosystems’ HeliFX endostapling system, but an analysis the group published last week received a stark review from MDDI Online.
In its report, Consumers Union portrayed medical devices as entirely lacking in safety testing, disregarding any studies that weren’t conducted in humans and saying that "for most implants and other high-risk devices brought to market, manufacturers do nothing more than file some paperwork and pay the FDA a user fee of roughly $4,000 to start selling a product that can rack up many millions of dollars in revenue," MDDI reported.
Biomet details the DePuy trauma bid
Biomet Inc. hashed out the details of its $280 million cash offer for Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopedics‘ global trauma business in regulatory documents filed this week.
Warsaw, Ind.-based Biomet hopes to expand its sports, extremities and trauma division with the acquisition, which will see DePuy’s trauma employees folded into the Biomet team in a deal that comes amid J&J’s attempted $21.3 billion buyout of Synthes.
The iPhone ECG is a rising star
The iPhone ECG proved to be a risking star, releasing study data at the American College of Cardiology conference last week touting the mobile application’s potential for uncovering otherwise undiagnosed cardiac anomalies, the Atlantic reported.
Noted physicist Stephen Hawking tests mind-controlled communication tech
Noted physicist Stephen Hawking, almost entirely paralyzed by amyotrophic lateral sclerosis, also known as Lou Gehrig’s disease, saw promise in the iBrain device, a high-tech headband that hopes to help people communicate through thoughts alone, the New York Times reported.
Handheld plasma flashlight kills dangerous pathogens on the skin
A team of scientists developed a handheld plasma-producing flashlight that may be able to instantly kill bacteria on the skin in emergency situations, such as natural disaster sites, ambulance emergency calls or military combat operations, according to a press release.
