Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Carestream, Fesariustherapeutics, Oxos, Roche, Ventris.
Johnson & Johnson halted the limited rollout of its Varipulse pulsed field ablation system on Jan. 5 to “investigate the root causes of four reported neurovascular events in the U.S. external evaluation.” So far, just 130 cases have been completed in the U.S. since the company received U.S. FDA approval in November for use in paroxysmal atrial fibrillation.
Fire1 Ltd. secured $120 million in financing to conduct a pivotal trial for its heart failure management system, Norm. The technology measures fluid in the inferior vena cava (IVC) and is expected to help the millions of people living with heart failure manage their condition and get their normal life back.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aerwave, Argon Medical, Biofidelity, Biostem, Caresyntax, Cellcarta, Endostream, Genialis, Inify, Kaneka, Peerbridge, Qaelon, Roivios, Tempus AI, Tricares.
2024 saw the completion of several cellular-resolution brain maps, including the entire fly brain and a comprehensive connections map of a cubic centimeter of human brain. 2025 began with the addition of another important map. In the Jan. 1, 2025, issue of Nature, researchers from the Allen Institute presented a map of areas and cell types where aging most affected the mouse brain.
Stressing the importance of integrity in taxpayer-funded biomedical research, the U.S. Department of Justice reported that Athira Pharma Inc. agreed to pay more than $4 million to resolve False Claims Act allegations that it failed to report potential research misconduct to the NIH and the Department of Health and Human Services’ Office of Research Integrity in grant applications and progress reports.
China’s health regulator gave conditional approval to Platinum Life Excellence Biotech Co. Ltd.’s amimestrocel injection (hUC-MSC PLEB-001, Ruibosheng) as the nation’s first human umbilical cord-derived mesenchymal stem cell therapy to treat steroid-refractory acute graft-vs.-host disease on Jan. 2, 2025.
In early validation of widespread predictions of a robust year for M&A activity, Boston Scientific Corp. signed a definitive agreement to acquire the 74% of Bolt Medical Inc. it doesn’t already own for $443 million up front and up to $221 million in contingent milestone payments.
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