The IPO market for med-tech companies continues to set new records. With one IPO closed the last week of June, two slated for the first week of July and another pending, 2025 will shortly exceed the total number of IPOs closed in the previous two years combined as well as the number completed in 2022. Read More
Could the U.S. FDA’s de novo marketing authorization for Tissium SA’s Coaptium Connect, an atraumatic sutureless solution for peripheral nerve repair, signal a transformative shift away from sutures in nerve surgery? Only time will tell. Read More
Tetratherix Ltd. raised AU$45 million (US$25 million) in its IPO on the Australian Securities Exchange (ASX:TTX) to support clinical development of its Tetramatrix polymer biomaterial platform to support bone regeneration, tissue spacing and tissue healing. Read More
The U.S. FDA finalized the latest edition of its premarket cybersecurity guidance, but the agency is of the view that any device with software is subject to the terms of the guidance even though the statute would seem to exempt device software that lacks connectivity. Read More
The U.K. Medicines and Healthcare Products Regulatory Agency reported June 24 it joined a global regulatory network for AI that is part of the Health AI regulatory initiative – a program that will invite another nine regulatory agencies to take part in the initiative in the months ahead. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 23andMe, 2MG Medical, Carmat, Catheter Precision, Endo Tools, Fujifilm Holdings, Intershunt, Spectral AI, Toby, Verge Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Empnia, Path AI. Read More
