MedTech News
Intuitive wins CE mark for da Vinci 5
Intuitive Surgical (Nasdaq: ISRG)+
announced today that it received CE mark for its da Vinci 5 surgical robotic system.
Fasikl wins FDA nod for tremor-treating wearable wristband
Fasikl announced that it received FDA 510(k) clearance for its first-of-its-kind NeuroAI wristband for essential tremor.
Bioengineered hydrogel mimics tumor environment to preserve live tissues for longer
A new hydrogel-based platform to preserve live patient-derived tumor tissues in the lab could pave the way for faster, more accurate testing of cancer treatments for patients with peritoneal metastases, a hard-to-treat and often deadly form of abdominal and pelvic cancers.
Researchers take major step toward cuff-free blood pressure monitoring
Researchers have shown, for the first time, that speckle contrast optical spectroscopy (SCOS) can be used for cuffless blood pressure monitoring. The new technology could improve early detection and management of hypertension.
Moon Surgical Receives FDA Clearance for Maestro™ Connectivity and Predetermined Change Control Plan for AI-Powered ScoPilot®
PARIS and SAN FRANCISCO, July 2, 2025 /PRNewswire/ — Moon Surgical, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for two major advancements to its Maestro System: connectivity of the platform to power the Maestro Insights product and a Predetermined Change Control Plan (PCCP) to evolve its AI-powered ScoPilot product.
Lifecare takes next steps in CGM implant development
Lifecare said on social media that it completed a significant milestone in the development of its continuous glucose monitor (CGM) implant.
SonoClear AS Receives FDA Breakthrough Designation for SonoClear® System
OSLO, Norway, July 1, 2025 /PRNewswire/ — SonoClear AS today announced that the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) has designated the SonoClear® System as a Breakthrough Device for use in intracranial ultrasound procedures.
EmpNia Receives FDA Clearance for eMotus™ Neuromodulation System
Regulatory Approval Paves the Way for U.S. Market Launch of Innovative Therapy Targeting Chronic Pain and Neurological Disorders