David Anderson says the road to developing an artificial spinal disc nucleus is littered with “spectacular failures.”But that doesn’t deter Anderson or his company, Philadelphia-based Gentis, from trying to be the first to get a disc nucleus replacement device for the lower spine on the U.S. market. The nucleus pulposus is the jelly-like substance found [...]

Minnesota’s medical device companies have openly fretted about the Food and Drug Administration altering or even eliminating the popular 510(k) clearance program.From venture capitalists and entrepreneurs to doctors and academics, the industry has complained that the FDA is already taking too long to make decisions, a harbinger of worse things to come. And since Minnesota [...]

Another day, another new local early stage fund.Upwind Medical Partners is launching a $6 million to $8 million early stage fund that will focus on commercializing intellectual property from health care/research institutions like the University of Minnesota, Wisconsin Alumni Research Fund (WARF), Allina Hospitals & Clinics, and John Hopkins Hospital in Baltimore.Founded by Jim O’Reilly, [...]

“We’re not here to bash the FDA,” Mark DuVal, president of Minneapolis law firm DuVal & Associates, told a group of medical device executives and investors late Wednesday afternoon.Too late.The newly formed Minnesota Medical Device Alliance billed the gathering in the downtown Warehouse District as the first step to help save the Food and [...]

The difficulties Olmsted County plaintiffs face in pursuing a medical malpractice claim against the Mayo Clinic, by far the area’s largest employer, were apparent in a recent appellate court decision in Becker et al. v. Mayo Foundation. The case involved an appeal from an Olmsted County jury’s finding that the clinic was not negligent in failing to report suspected abuse of an infant.