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 […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
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 […]
FDA issues warning letter to Medline over plastic syringes from China
The FDA followed up on a 2023 warning letter over unauthorized plastic syringes by issuing a warning letter to Medline. 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 issues associated […]
Health Canada licenses Medtronic Symplicity Spyral renal denervation system
Medtronic announced today that it received a license from Health Canada for its Symplicity Spyral renal denervation (RDN) system. The licensing covers the management of essential hypertension in patients for whomblood pressure remains uncontrolled despite lifestyle modifications and guideline-driven medical therapy with antihypertensive medications, or when guideline-driven therapy is poorly tolerated. Approval in Canada comes […]
Avail Medsystems tech sold to robotics startup founded by former Auris leaders
Medical robotics startup Mendaera has purchased the technology of Avail Medsystems and hired some of its employees, Mendaera co-founder and CEO Josh DeFonzo said in an exclusive interview. The deal includes “substantially all” of Avail’s assets, said DeFonzo, who offered new details on his company’s objectives as it exits stealth mode. He declined to disclose […]
Intuitive details da Vinci 5 launch plans with limited supply of next-gen surgical robotics systems
Intuitive Surgical is planning a phased launch of its da Vinci 5 that will stretch into next year, executives said today. Intuitive won FDA 510(k) clearance for its next-generation surgical robotics system last week, nearly one decade after winning clearance for the da Vinci Xi system. “We are planning for a limited launch starting in […]