MedTech News
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.
FDA Clears AIOMEGA’s AIO Breathe, for Treatment of Obstructive Sleep Apnea
TYLER, Texas–(BUSINESS WIRE)– AIOMEGA, a Texas biomedical company, announced that AIO BREATHE, their medical device that treats Obstructive Sleep Apnea, has been cleared by the Food and Drug Administration.
Nevro Receives FDA 510(k) Clearance to Use SI Fixation System Without Need to Include Lateral Screw
Nevro1™ Proven to Immediately Transfix Sacroiliac (SI) Joint to Allow for Long-term SI Joint Fusion