Here are some of the top stories at MedCity News this week:
— Minnesota Sens. Amy Klobuchar and Al Franken along with Rep. Erik Paulsen have championed the medical device industry’s fears about upcoming changes to the FDA’s 510(k) approval program. I doubted the campaign would do much. But with the FDA close to recommending its changes, a bipartisan group of 15 senators sent a letter to FDA Commissioner Dr. Margaret Hamburg urging her agency, among other things, to adopt a more deliberate, cautious approach to amending 510(k).
— Orthopedics company Stryker Corp. (NYSE:SYK) has agreed to sell a product line including the bone growth putty that has caused the company so much legal grief to Olympus Corp. for $60 million. Kalamazoo, Michigan-based Stryker plans to record a loss on the sale of its OP-1 product line — which includes OP-1 implant, OP-1 putty, Opgenra and Osigraft — as well as a manufacturing plant in Lebanon, New Hampshire, of between $75 million and $80 million. That would erase between 19 cents and 20 cents a share from the company’s fourth-quarter earnings.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
— A group of University of Minnesota professors want the board of regents to investigate the suicide of a patient enrolled in a university-run drug study. Led by Dr. Carl Elliott, the professors demand the regents appoint an independent outside panel of experts to examine the death of Dan Markingson, a mentally ill patient who killed himself after taking an experimental psychiatric drug developed by AstraZeneca. The professors accuse the school of several ethics violations, including financial conflict of interest and enrolling Markingson even though he may have been too sick to consent.
— Medical device startup NeuroWave Systems Inc. has received its first regulatory clearance from the Food and Drug Administration to begin selling a brain-activity monitoring system. The Cleveland Heights, Ohio-based company’s NeuroFAST Monitoring System is intended for use in hospital operating rooms, emergency departments and intensive care units, plus for clinical research.
— Neoprobe Corp. (OTCBB:NEOP) continues to take steps down the regulatory path to restart development efforts for its RIGScan cancer-detecting technology. The Dublin, Ohio-based company has been granted a first-quarter meeting with the Food and Drug Administration to discuss its plans to begin clinical testing that would lead to an Investigational New Drug application for RIGScan, which works by attaching itself to cancerous cells in the body, making them identified by a hand-held radiation-detection device.
