Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott, Alfarim, Beta Bionics, Bioness Medical, Carmat, Gradient Denervation, Harmonic Bionics, Ionetix, Induction Healthcare, Vitalhub.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aventamed, Expanding Innovations, Happy Health, Levita, Zilia.
On the same day that FDA Commissioner Martin Makary spoke in a fireside chat during the 2025 Biotechnology Innovation Organization’s International Convention, the agency unveiled a pilot commissioner’s national priority voucher program that will enable companies to receive a shortened FDA review time of one to two months.
Using informed consent to do what Congress couldn’t, the U.S. FDA is flexing its regulatory authority to halt clinical trials that involve sending cells from American patients to China or other adversarial nations for genetic engineering and subsequent infusion back into the patient.
At the Annual Congress of the European Association for Cancer Research (EACR) in Lisbon, multiple sessions aimed to provide fresh perspectives on the always challenging treatment of cancer, with a strong focus on innovative strategies.
Amid rising demand for its Neuromark system, Neurent Medical Ltd. opened a new manufacturing facility in Ireland, which will serve as the central hub for the production of the device which treats chronic rhinitis.
Researchers from the University at Buffalo, the State University of New York (SUNY), filed for protection of their development of a new imaging technology that uses radar and AI to see through dressings to monitor wounds and other skin conditions.