The draft Medicare physician fee schedule (MPFS) for 2026 proposed to treat skin substitutes as incident-to supplies in the related procedures, but the blowback was pronounced and vigorous, with London-based Convatec plc arguing that the agency lacks the statutory authority to make such a change.
The first phase of the EU’s Data Act is now officially in place, although member state enforcement of the Act might be spotty. This is because several nations, including Germany, have yet to finalize implementing regulations for the Data Act, a problem these nations will have to fix as the secondary and tertiary compliance dates arrive in August 2026 and August 2027.
Through the first eight months of 2025, med-tech M&A deal value reached $30.74 billion, a modest rebound from $34.77 billion during the same period in 2024. August contributed $2.42 billion, down from July’s $6.21 billion, yet still ahead of several earlier months in 2025.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Avanos Medical, Hapbee technologies, Medtronic.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avita, Icecure, Merit, Mevion, Novocure, Pulnovo.
Tensive Srl's Regenera, a bio-absorbable breast implant, promises to help the millions of women who undergo breast cancer surgery every year, to feel whole again. “While surgery will save many lives, it comes at the cost of losing something very personal, which is the sense of a woman's wholeness. I think that's what has been a major challenge,” Sanjay Kakkar, CEO told BioWorld.