Shares of Mountain View, Calif.-based Heartflow Inc. have oscillated significantly over the past three months, but the results of a study of the company’s plaque staging system have breathed new life into the company’s shares, boosting them by 7% in Nov. 10 trading.

Medical Microinstruments Inc., reported the U.S. FDA approval of an investigational device exemption for a study using its Symani surgical system for treating Alzheimer’s disease, one of its earliest forays into the brain.

The U.K. Medicines and Healthcare Products Regulatory Agency has laid out an approach to medical products for rare diseases, which the agency said afflict 3.5 million U.K. citizens. One of the objectives of this program is to simplify evidence requirements for these therapies with the hope of providing patients with more rapid access to much-needed therapeutic options.

Baxter International Inc. recently received clearance under the Medical Device Regulation for its Floseal Hemostatic Matrix device, a proven adjunct hemostatic agent effective in a wide range of bleeding scenarios. With bleeding control still a critical concern, the device offers health care professionals a reliable solution to enhance patient safety and improve surgical outcomes.

Oxford Nanopore Technologies plc and Biomérieux SA launched Ampore-TB, a research use only test that can rapidly detect mutations linked to antimicrobial resistance in tuberculosis. With multidrug-resistant TB affecting an estimated 400,000 people annually and increasing risks of morbidity and mortality, this assay could help with earlier diagnosis of drug resistance in patients.

The U.S. FDA’s attempts to harmonize with other nations on quality management received a dose of good news recently when the International Organization for Standards decided to stand pat on ISO 13485, which also leaves the FDA’s Quality Management System Regulation intact.

Not quite a newco, Alethio Therapeutics has emerged from a period of introspection with new management and a refreshed vision of how best to translate its roots in the biology of chronic, untreatable blood cancers into meaningful therapies.

Centessa Pharmaceuticals plc’s unremarkable third-quarter 2025 earnings report was greatly overshadowed by an early readout from its orexin receptor 2 (OX2R) agonist program in narcolepsy, particularly promising phase IIa data demonstrating ORX-750’s efficacy across a group of sleep disorders, though investors seek further data to differentiate Centessa’s program from potential competitors such as Takeda Pharmaceutical Co. Ltd.’s oveporexton and Alkermes plc’s alixorexton.

Tulyp Medical Inc. has emerged from stealth mode with a pressure-driven perfusion system designed to improve vascular procedures. The company, born out of Sofinnova Partners' medical device accelerator, has submitted the technology to the U.S. FDA for 510(k) clearance following initial clinical results that demonstrated safety and functionality.