Pulse Biosciences wins FDA IDE to study PFA tech
December 18, 2025
Pulse Biosciences (Nasdaq:PLSE) announced today that the FDA granted investigational device exemption (IDE) for a pulsed field ablation (PFA) study.
Pulse Biosciences (Nasdaq:PLSE) announced today that the FDA granted investigational device exemption (IDE) for a pulsed field ablation (PFA) study.
Abbott (NYSE: ABT)+
announced today that it received FDA clearance for its Amplatzer Piccolo delivery system for use with the Amplatzer Piccolo Occluder.
Medtronic (NYSE: MDT)+
and Johnson & Johnson (NYSE: JNJ)+
have both announced recent regulatory milestones for liquid embolic systems.
CMR gained FDA marketing authorization for its first-generation Versius robot in October 2024 through the de novo pathway. In April, the company said it raised more than $200 million to support the commercialization of Versius.
Zephyrus Innovations (Zephyrus), a privately-owned medical device company designing and manufacturing safety syringes and Closed System Transfer Devices (CSTDs), today announces that it has received product 510(k) Marketing Clearance from the US Food and Drug Administration (“FDA”) for its VaporShield ™ CSTD.
New production capacity strengthens MPM Medical’s position as a leading U.S. manufacturer and follows the company’s recent launch of collagen at-home wound care kits
According to a US pivotal study, the device’s sensitivity has been reported at more than 76% on all specimens.
BlueWind Medical announced today that the FDA granted 510(k) clearance for its enhanced Revi implantable tibial neuromodulation (iTNM) system.
Medivis announced today that it received FDA 510(k) clearance for its augmented reality (AR)-powered Cranial Navigation platform.
The Anavi system treats polycystic ovary syndrome by delivering targeted radiofrequency energy to ablate ovarian tissue to re-initiate ovulatory cycles.