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. Read More
Roche AG has become the latest pharmaceutical company to respond to the Trump administration’s threat to impose tariffs, saying it will invest $50 billion in drug and diagnostics manufacturing in the U.S. over the next five years. That figure matches a similar commitment by its Basel, Switzerland-based neighbor, Novartis AG, which on April 11 said it would be investing almost $50 billion in the U.S., also over the next five years. Read More
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. Read More
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. Read More
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.” Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aerin Medical, Icecure, Myriad Genetics, Sky Labs, Surmodics. Read More
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. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Novocure, Vivasure. Read More