The U.S. FDA released the latest version of its premarket cybersecurity guidance regarding medical devices, replacing the 2025 edition and offering recommendations on implementing measures for preventing digital attacks or authorized access.
Seluna Ltd. launched a clinical study to validate its sleep diagnostic software, designed to support doctors to rapidly diagnose childhood sleep disorders and prioritize treatment for those who urgently need it. The study follows Seluna’s recent securing of nearly £650,000 (US$875,000) in funding.
On the heels of U.S. FDA approval for Neurophet Aqua, an updated version of its artificial intelligence (AI)-based magnetic resonance imaging analysis software for the brain, Neurophet Inc. is preparing for an IPO in 2025 and expansion into U.S. and European markets.
