The Advanced Medical Technology Association released a policy proposal for AI in medical devices that took the U.S, FDA to task for its guidance for predetermined change control protocols for AI, stating that the guidance is “inconsistent with the statutory authority” for PCCPs.

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.