Masimo wins expanded FDA nod for O3 regional oximetry
August 19, 2025
Masimo (Nasdaq: MASI)+
announced today that it received FDA 510(k) clearance for expanded indications for its O3 regional oximetry technology
Masimo (Nasdaq: MASI)+
announced today that it received FDA 510(k) clearance for expanded indications for its O3 regional oximetry technology
Tandem Diabetes Care (Nasdaq:TNDM) has a new infusion set on the way to pair with its insulin delivery offerings.
ANKARA, Türkiye, Aug. 18, 2025 /PRNewswire/ — Nerveblox, an AI software solution by SmartAlpha, designed to assist physicians in using ultrasound while administering regional anesthesia procedures commonly known as ‘nerve blocks’, has received U.S. Food and Drug Administration (FDA) 510(k) clearance.
Two studies led by Johns Hopkins Kimmel Cancer Center, Ludwig Center, and Johns Hopkins Whiting School of Engineering researchers report on a powerful new method that significantly improves the reliability and accuracy of artificial intelligence (AI) for many applications.
Millions of Americans have altered vision, ranging from blurriness to blindness. But not everyone wants to wear prescription glasses or contact lenses. Accordingly, hundreds of thousands of people undergo corrective eye surgery each year, including LASIK—a laser-assisted surgery that reshapes the cornea and corrects vision.
BURLINGTON, N.C., Aug. 18, 2025 /PRNewswire/ — Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the availability of the Lumipulse® pTau-217/Beta Amyloid 42 Ratio, the first blood-based in-vitro diagnostic (IVD) test cleared by the U.S. Food and Drug Administration (FDA) to aid in the diagnosis of Alzheimer’s disease.
The company is collaborating with local companies and healthcare providers to distribute the ulcer test.
NeuroOne (Nasdaq:NMTC) announced today that it received FDA clearance for its OneRF trigeminal nerve ablation system.
Onward Medical announced today that it received FDA investigational device exemption (IDE) for its ARC-IM system.
A Medical University of South Carolina team reports in Frontiers in Immunology that it has engineered a new type of genetically modified immune cell that can precisely target and neutralize antibody-producing cells complicit in organ rejection.