A review of life science current events reported by MedCity News this week:
Obstructive sleep apnea treatment will change. But who will lead the way? Inspire Medical Systems and Apnex Medical, both from Minnesota, are technically similar in that both companies are developing technologies that sense respiration and deliver mild stimulation to treat obstructive sleep apnea. A third company based in San Diego – ImThera – is also developing an implantable solution, but unlike Inspire and Apnex, the product doesn’t have a mechanism to sense respiration.
510(k) approval process is too big to fail no matter how flawed it may be. In an interview following the release of the report, one of the 11-member IOM panel that provided the non-binding recommendations told MedCity News that the FDA has been “heroically” trying to make sure that products cleared through the 510(k) process are both “safe and effective.” But the FDA has been given the wrong tool to make that determination.
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.
Minnesota ‘biotech incubator’ UEL has failed. It’s time to admit it. UEL picked too big of a space in the wrong kind of building. It carried large debt from inception. And when the university didn’t create enough startups, UEL gave space to anyone in order to stay afloat. What’s more, UEL never tracked key metrics, like job creation, from startups that did flourish under its care. Now UEL is full and most new university spinoffs go elsewhere.
Male incontinence device being developed by Ohio startup. Columbus-based Continental Dry Works‘ male urinary incontinence product, called The Pocket, resembles an athletic cup and could easily be removed from the pants and discarded. The new innovative medical device features a layer of quick-drying mesh, similar to swimsuit netting, that would hold the user’s scrotum away from a layer of absorbent material that collects urine and sits inside a semi-rigid outer shell, according to company founder Heather Wilcox.
FDA says CRO Cetero faked trial data; pharmas may need to redo tests. In a July 26 letter to Cetero, the U.S. Food and Drug Administration describes the falsification as “extensive,” calling into question all bioanalytical data collected by Cetero’s Houston bioanalytical laboratory from April 1, 2005 to June 15, 2010. The FDA said Cetero manipulated test samples so the tests would yield desired results. The FDA did not identify any of the drugs or sponsoring drug companies whose data was affected.
