Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alcon, Bonesupport, Covalon, Medtronic, Shiratronics, Tandem Diabetes.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avita Medical, Biocartis, Body Vision Medical, Penumbra, Womed.
Recent comments from CDER Director George Tidmarsh suggesting that the agency may be backing away from the use of its independent expert panels for individual product approvals seem to be supported by the numbers.
German bionics leader Ottobock SE & KGaA plans to list on the Frankfurt Stock Exchange by the end of the year in an IPO targeting gross proceeds of €100 million (US$117.7 million). Ottobock would be the fourth European company to go public this year, a good sign for the European med-tech market, which had not seen any since the first half of 2022.
Uncertainties brought on by tariffs have certainly dampened the optimism in the med tech sector seen at the beginning of the year, as it has slowed M&A and fundraising activity. However, companies developing differentiated products based on solid technology, supported by substantial clinical data, will attract financing and M&A activity will return, Luc Marengère, managing partner at TVM Capital Life Science, told BioWorld.
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.
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