Harvard University has filed a lawsuit claiming the Trump administration’s freezing of its federal funding is unlawful and beyond the government’s authority. Announcing the move, Harvard’s president, Alan Garber, highlighted the impact of freezing $2.2 billion in grants – and the threat to freeze a further $1.1 billion – will have on the university’s biomedical research.
If U.S. sectoral tariffs on biopharmaceuticals become a reality and most country-by-country tariffs on other medical products resume, manufacturers may have to rethink their use of U.S. free trade zones to turn foreign-sourced active pharmaceutical ingredients and other components into finished products for the U.S. market.
Field Medical Inc. reaped $40 million in its series A fundraising via $20 million in new capital and conversion of $20 million in seed-round debt to support development of its next-generation pulsed field ablation technology. Field Medical’s Fieldforce ablation system targets ventricular tachycardia as its initial use, but also has a study in process for atrial fibrillation.
Baxter International Inc. recently launched in Europe a new version of its surgical patch, the Hemopatch Sealing Hemostat, which can be stored at room temperature. The improved Hemopatch device eliminates the need for refrigeration, allowing surgeons to have the product on hand to quickly control bleeding or prevent leakage during surgery.
Sky Labs Inc. CEO and founder Jack Byunghwan Lee reported on plans to greatly expand the market for the company’s blood pressure monitor ring, including seeking regulatory approvals for the CART BP products in the U.S., Europe and Japan.
The European Association of Medical Device Notified Bodies inked a position paper on the EU Artificial Intelligence Act which recites some standing concerns. Perhaps the most interesting passage in the paper is that there is a need for a “well-coordinated approach between member states that are in charge of notified body oversight.”
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aerin Medical, Icecure, Myriad Genetics, Sky Labs, Surmodics.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biostate AI, Digitcells, Elutia, Enzo Biochem, Gopath, Mindpeak, Orchestra Biomed, Perfuze, R3 Vascular, Theranica.