The U.S. FDA’s 510(k) program is yet again under assault, this time from the authors of a Jan. 10 article in the Journal of the American Medical Association (JAMA). The authors’ primary point seems to be that any 510(k) devices that recite a predicate that is the subject of at least three recalls are themselves more likely than average to be the subject of a recall, although there was no discernible association between recall status and technological differences between the predicate and the follow-on devices. Read More
The U.S. FDA and Health Canada announced that they will roll out a pilot program that allows a medical device manufacturer to submit a medical device application to both agencies simultaneously for class II and class III medical devices. Read More
GSR Ventures, a venture firm focused on early stage digital health companies, forecasts a much brighter investment picture for 2023 following a hard reset in 2022, said GSR Partner Sunny Kumar in an interview with BioWorld at the J.P. Morgan Healthcare Conference in San Francisco. Read More
Volta Medical SAS reported raising $39 million in a series B round to roll out its VX1 software mapping system in Europe and the U.S. This artificial intelligence (AI) algorithm is compatible with most readily available multi-polar catheters and technology used in operating rooms and cath labs in the treatment of complex cardiac arrhythmia. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cardiovascular Systems, Cbr International, Easthorn, Gentuity, Novotech, Paige, Pear. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Diacarta. Read More
