Abbott today announced two new regulatory approvals related to its TactiFlex and FlexAbility ablation catheters. TactiFlex ablation catheter, sensor enabled (SE), received a CE mark for treating abnormal heart rhythms such as atrial fibrillation. The company's FlexAbility ablation catheter, SE, also received an expanded indication from the FDA … [Read more...] about Abbott scores regulatory wins in electrophysiology
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FDA labels Medtronic recall of some Mahurkar hemodialysis catheters as Class I
The FDA this week said the Medtronic (NYSE:MDT) recall of some Mahurkar hemodialysis catheters is Class I, the most serious kind. Medtronic is recalling its Mahurkar acute dual lumen high flow 13.5 Fr hemodialysis catheters, also known as Mahurkar QPlus, due to reports of a potential catheter hub defect that could cause leaks in a catheter's … [Read more...] about FDA labels Medtronic recall of some Mahurkar hemodialysis catheters as Class I
IceCure Medical wins minimally-invasive cryoablation catheter patent in Japan
IceCure Medical recently announced it received a patent in Japan for its cryogen pump for cryoablation procedures. Caesarea, Israel-based IceCure Medical's cryogenic pump is submersible in liquid nitrogen, works in a closed circuit and improves the cooling rate during a procedure. The company designed it for multiple or longer-duration … [Read more...] about IceCure Medical wins minimally-invasive cryoablation catheter patent in Japan
Surmodics announces regulatory delay for its SurVeil balloon
The FDA said it needed more information on biocompatibility and labeling.
The FDA has indicated that Surmodics' Surveil drug-coated balloon premarket approval application is not approvable.
According to an FDA letter to the company, Surmodics' Surveil was not approved due to certain information in the biocompatibility and labeling categories. The governing agency said more information needs to be added by an amendment … [Read more...] about Surmodics announces regulatory delay for its SurVeil balloon The FDA said it needed more information on biocompatibility and labeling.
Shockwave Medical to acquire Neovasc for up to $147M
Shockwave Medical (NSDQ:SWAV) this week announced it signed an agreement to acquire all of the issued and outstanding common shares of Neovasc (NSDQ:NVCN). Neovasc enrolled its first patient in a clinical trial studying the Neovasc Reducer in January 2022. The company designed the device to reduce angina symptoms in people with refractory … [Read more...] about Shockwave Medical to acquire Neovasc for up to $147M
Gemini Medical partners with UroGPO for improved access to air-charged urodynamic catheters
Gemini Medical Technologies this week announced it entered a partnership with UroGPO, a Specialty Networks Company, to give urologists access to affordable air-charged urodynamics catheters. UroGPO members will gain access to Gemini's Atmos air-charged urodynamics catheter line through the deal. Atmos is made from a flexible polyurethane … [Read more...] about Gemini Medical partners with UroGPO for improved access to air-charged urodynamic catheters
Ra Medical realigns board of directors following merger
Ra Medical Systems (NYSE:RMED) this week announced the realignment of its board of directors in conjunction with the recently announced merger with Catheter Precision. David Jenkins joins the board as executive chair, and James Caruso will serve as a director. Martin Colombatto, Will McGuire and Susann Meline will serve as directors. … [Read more...] about Ra Medical realigns board of directors following merger
BD issues urgent field safety notice for Venovo venous stent system
BD has issued an urgent field safety notice for its Venovo venous stent system. The notice out of Germany warns of potential delayed deployment and silicone embolization if the proximal end of the Venovo venous stent system does not immediately expand upon deployment and remains connected to the stent cushion on the delivery system. According … [Read more...] about BD issues urgent field safety notice for Venovo venous stent system
Ra Medical Systems completes merger with Catheter Precision
Ra Medical Systems (NYSE:RMED) and Catheter Precision this week announced the completion of their stock-for-stock merger transaction. The deal was previously announced in September 2022. Under the terms of the agreement, Catheter Precision becomes a wholly-owned subsidiary of Ra Medical. The combined company will focus on the cardiac … [Read more...] about Ra Medical Systems completes merger with Catheter Precision
Endoron Medical awarded €2.5M European Commission grant for endovascular repair device
Endoron Medical recently announced it was awarded a €2.5 million grant by the European Commission under the EIC Accelerator program. Tel Aviv, Israel-based Endoron is developing an innovative solution for the endovascular repair of abdominal aortic aneurysms (AAA). The grant will support the scale-up and clinical evaluation of the Aortoseal … [Read more...] about Endoron Medical awarded €2.5M European Commission grant for endovascular repair device
