FDA preemption of state liability law has proven controversial on a number of occasions, a fact of life resurrected by a case arising out of the Supreme Court of the State of Mississippi. The court declared that the FDA must invoke the rulemaking process for its regulation of medical product labels.

Mindmaze SA raised $125 million in a debt financing round led by Albacore Capital Group to expand its virtual reality-based digital neurotherapeutics platform. Total funding for Mindmaze now exceeds $235.7 million to date. Investors include the Hinduja Group, Venture Kick, the Foundation for Technological Innovation, and Leonardo DiCaprio. The Mindmaze platform assesses and restores cognitive and motor function in individuals who have sustained neural injuries or impairment from degeneration and aging.

The FDA’s push toward safety has included an examination of the materials used in medical devices, but a recent report sheds little useful light on whether these materials are provoking a response in patients.

The term of follow-up in clinical studies is the subject of massive speculation at FDA advisory hearings, but a recent FDA workshop suggests the agency may adjust its expectations, depending on the device. Darrell Brodke, of the University of Utah, said on a recent spinal device workshop that the two-year endpoint in some spinal device studies struck him as somewhat arbitrary, adding that a longer duration of follow-up is necessary to capture some device failures, but that two years is perhaps overly long where some other outcomes measures are concerned.

Calpro AS and Ampersand Health Ltd. are combining technologies to provide a self-management and remote monitoring solution for people with inflammatory bowel disease (IBD). The partnership will integrate Oslo, Norway-based Calpro’s smart biomarker test with Ampersand’s digital therapeutic app My IBD Care. The companies said the collaboration could help reduce the administrative burden of IBD patient care.

Chinese med-tech firms are still flocking to list on the Hong Kong Stock Exchange despite recent disappointing performances. One of these companies is Shanghai Microport Medbot (Group) Co. Ltd., which is looking to raise up to $1 billion in a Hong Kong initial public offering (IPO). Proceeds from the listing will be used for the R&D and commercialization of its core product Toumai Laparoscopic Surgical Robot.