MedTech News
RDS granted CE mark for MultiSense remote monitoring wearable
RDS, the medical device start-up, has been granted the CE mark for MultiSense, its patented, wearable solution for continuous Remote Patient Monitoring.
FDA clears first over-the-counter CGM from Dexcom
Dexcom (Nasdaq:DXCM) announced today that the FDA cleared its Stelo glucose biosensor that does not require a prescription.
Biosense Webster receives CE mark for VARIPULSE PFA Platform
Biosense Webster, a cardiac arrhythmia treatment specialist and part of Johnson & Johnson MedTech, has received CE mark approval for the VARIPULSE Platform for the treatment of symptomatic drug refractory recurrent paroxysmal atrial fibrillation (AF) using pulsed field ablation (PFA).
Medtronic wins FDA clearance for bone tumor ablation tech
Medtronic (NYSE: MDT)+
announced today that it received FDA 510(k) clearance for its OsteoCool 2.0 bone tumor ablation system.
FDA approves Boston Scientific’s Agent drug-coated balloon
Boston Scientific (NYSE: BSX)+
announced today that it received FDA approval for its Agent drug-coated balloon (DCB).
FDA clears new radiotherapy systems from Siemens Healthineers’ Varian
Varian announced today that it received FDA 510(k) clearance for its TrueBeam and Edge radiotherapy systems with HyperSight imaging.
New Soldier® High Flow Microcatheter Granted FDA Clearance
FDA Clears Soldier Microcatheter for Localized Drug Delivery in Vascular Interventions
Onward wins FDA breakthrough nod for use of neurostim with brain-computer interface
Onward Medical announced today that the FDA granted breakthrough device designation for its ARC-BCI system that uses brain-computer interface (BCI) technology.