The U.S. FDA has issued a final order to reclassify optical diagnostic devices for melanoma detection and electrical impedance spectrometers from class III to class II, with special controls required.

A five-year reauthorization of the U.S. Small Business Innovation Research (SBIR) and Small Business Technology Transfer programs is just the president’s signature, or a few days, away.

CMR Surgical Ltd.’s participation in Nvidia’s Physical AI health care robotics initiative is expected to accelerate the development of the next generation of intelligent surgical robotic systems powered by data, simulation and AI. As demand for minimally invasive procedures grows, more companies are entering the surgical robotics space.

Crushing the hopes of drug and device companies, the U.S. Supreme Court’s March 23 orders list showed it denied cert in Takeda Pharmaceutical v. Painters & Allied Trades, which sought to rein in the expansion of class action lawsuits.

As the development of brain-computer interface (BCI) technologies gain momentum, Paradromics Inc. is building an ecosystem to enable collaboration between the company and academic researchers.

Minimed Group Inc. secured U.S. FDA approval for Minimed Flex, its next-generation discreet, smartphone-controlled insulin pump. The nod from the FDA follows the company’s debut on Nasdaq March 6. About half the size of the Minimed 780G pump and roughly the size of two stacked insulin vials, the screenless pump was designed in collaboration with people living with diabetes to offer a more intuitive, lifestyle‑friendly way to manage the condition.

Embecta Corp. agreed to acquire Owen Mumford Holdings Ltd. for up to £150 million (US$200 million) in a bid to boost its drug-delivery platforms and medical device technologies. Specifically, the deal will bring to Embecta’s portfolio Owen Mumford’s Aidaptus autoinjector, a two-step, single use platform designed to accommodate both 1-mL and 2.25-mL prefilled glass syringes in the same base device.

As AI continues to storm into global life, biopharma companies are figuring out ways to incorporate it into their operations, all with the goal of bringing better therapies to patients faster. At Pharma USA, a Reuters Events meeting in Philadelphia March 16-17, numerous AI companies presented their offerings to attendees, driving interest and partnerships.

Imperative Care Inc. secured $100 million through an oversubscribed convertible note financing round to support commercialization of its stroke and vascular thrombectomy technologies. The round was co-led by new investors Elevage Medical Technologies and Perceptive Advisors alongside existing investor Catalio Capital Management LP. Also participating were new backers Longaeva Partners LP and Brown Advisory, with continued support from existing investors, including Ally Bridge Group and Bain Capital Life Sciences.

Samsung Electronics Co. Ltd. is partnering with Verily Life Sciences LLC, an Alphabet Inc. company, and B.well Connected Health to turn Samsung Galaxy phones and smart watches into the “front door” of U.S. health care.