Medtronic announced today that the FDA approved its next-generation Evolut FX+ transcatheter aortic valve replacement (TAVR) system. The FDA’s approval covers the treatment of symptomatic aortic stenosis. Medtronic says the latest version of the Evolut valve maintains the performance of the Evolut platform with a design that facilitates coronary access. Evolut FX+ TAVR offers larger […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
FDA clears redesigned kidney stone treatment tech from Calyxo
Calyxo announced today that it received FDA clearance for its new, redesigned CVAC system for minimally invasive kidney stone treatment. Pleasanton, California–based Calyxo’s CVAC system uses irrigation and aspiration to remove kidney stones. The design aims to minimize residual stone burden. CVAC’s original design, which used steerable ureteroscopic renal evacuation (SURE) already successfully treated more […]
GE HealthCare to distribute newly FDA-cleared remote patient support tech
GE HealthCare today announced it will distribute Ionic Health’s nCommand Lite, now that the tech has secured FDA 510(k) clearance. Ionic Health designed nCommand Lite to support remote patient scanning, image viewing/review and real-time guidance from remote experts during scanning procedures. It aims to address staffing shortages in radiology departments. GE Healthcare will exclusively distribute […]
FDA clears Neuronetics’ neurostim for adolescents with depression
Neuronetics (Nasdaq:STIM) announced today that it received FDA clearance for the use of its NeuroStar therapy for adolescent patients. Clearance covers the use of NeuroStar as an adjunct treatment of major depressive disorder (MDD) in adolescent patients aged 15-21. Neuronetics said clearance makes NeuroStar the first and only transcranial magnetic stimulation (TMS) treatment cleared for […]
J&J’s Biosense Webster submits Varipulse pulsed field ablation system for FDA approval
Johnson & Johnson MedTech’s Biosense Webster announced today that it submitted its Varipulse platform to the FDA for premarket approval. The company supported its PMA submission for the pulsed field ablation (PFA) system with results from the admIRE study. It aims to garner approval for the treatment of paroxysmal AFib. If approved, Varipulse would become […]
FDA adds SetPoint Medical and its multiple sclerosis-treating neuromod to advisory program
SetPoint Medical announced today that the FDA accepted it into the Total Product Life Cycle Advisory Program (TAP) pilot. TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates rapid development and widespread access to medical devices. Acceptance requires breakthrough device designation, which SetPoint Medical garnered last week. With […]
J&J’s Abiomed has a Class I Impella labeling recall with 49 deaths related to issue
The FDA deemed a recall of heart pumps from Johnson & Johnson MedTech’s (NYSE:JNJ) Abiomed Class I, the most serious kind. Abiomed reports 129 serious injuries, including 49 deaths, related to the issue of potential cuts in the wall of the heart. This recall (a correction and not a product removal) affects 66,390 Impella pumps […]
BD ups domestic syringe production in wake of FDA warnings on syringes made in China
BD (NYSE:BDX) announced today that it is increasing its U.S. syringe production after the FDA issued warnings related to syringes manufactured in China. In November, the FDA warned of the potential for device failures with plastic syringes manufactured in China. Failures could include leaks, breakage and other problems. The agency said it received information about quality […]
FDA clears self-driving mobile C-arm from Siemens Healthineers
Siemens Healthineers announced today that the FDA granted clearance for its Ciartic Move mobile C-arm with self-driving capabilities. Ciartic Move accelerates and standardizes 2D fluoroscopic and 3D cone-beam computed technology (CT) imaging. Working in hospitals and outpatient facilities, it enables consistent automated workflows and reduced imaging time. Siemens Healthineers designed the system to address the […]
Intuitive Ion wins regulatory approval in China
Intuitive Surgical has received approval from regulatory authorities in China to market its Ion surgical robot system. BTIG analyst Ryan Zimmerman said today that the National Medical Products Administration in China approved the system. This occurred through Intuitive’s partnership with Shanghai Fosun Pharmaceutical, a venture established in 2016. The major regulatory nod in China follows […]
Butterfly Network wins CE mark for IQ+ handheld ultrasound tech, hopes for next-gen nod this year
Butterfly Network (NYSE:BFLY) announced today that it garnered CE mark approval for its Butterfly iQ+ ultrasound system. The company obtained European Union Medical Device Regulation (EU MDR) certification for the iQ+ system. It initially received CE mark in 2021, but had to fall in line with updated, more stringent regulations in Europe. According to a […]