Cardiosense wins FDA clearance for wearable sensor
July 28, 2025
Cardiosense announced today that it received FDA 510(k) clearance for its CardioTag wearable sensor device.
Cardiosense announced today that it received FDA 510(k) clearance for its CardioTag wearable sensor device.
The test employs advanced RNA technology to identify biomarkers for colorectal cancer and advanced adenomas.
Simplified Process Aims to Boost Participation in Colorectal Cancer Screening and Improve Early Detection Rates
STEWARTVILLE, Minn., July 24, 2025 /PRNewswire/ — Minnesota Medical Technologies, today announced that it received FDA 510(k) clearance for its fecal incontinence device (“StaySure(™)”).
ALISO VIEJO, Calif., July 23, 2025 /PRNewswire/ — In a major milestone for chronic post-amputation pain treatment, the first commercial patient in the U.S. has been successfully implanted with the FDA-approved Altius® System – marking the beginning of the company’s mission to relieve pain and restore life for lower limb amputees.
New AI-Enabled Technology Aims to Personalize Fluid Management and Improve Outcomes Across Hospital Network
Philips (NYSE: PHG)+ announced today that it received FDA 510(k) clearance for the latest UroNav image-guided navigation system.
Elekta announced today that it received FDA 510(k) clearance to expand indications for its Leksell Gamma Knife radiosurgery system.
Imperative Care announced today that it received FDA 510(k) clearance for its novel Zoom 7X catheter for aspiration thrombectomy procedures.
The CE mark also allows Medtronic’s automated insulin delivery system to be used during pregnancy and by children as young as 2.