Ra Medical Systems (NYSE:RMED) CEO Will McGuire this week announced his resignation from the company due to personal reasons. The resignation will take effect on April 28. He will also resign from his position on the board of directors of the electrophysiology procedures tech company. Ra Medical’s board of directors has established a … [Read more...] about Ra Medical Systems CEO resigns
IceCure Medical wins regulatory approval in China for disposable cryoprobes
IceCure Medical recently announced it received regulatory approval in China for its IceSense3 disposable cryoprobes. With the approval, the company and its partners in China can begin to treat malignant and benign tissue of the breast, lung, bone, liver and kidneys, as well as palliative interventions. "With approximately 430,000 new breast … [Read more...] about IceCure Medical wins regulatory approval in China for disposable cryoprobes
FDA clears Gravitas Medical’s smart feeding tube
Gravitas Medical this week announced it received FDA 510(k) clearance for its Enteric feeding tube system and feeding tube. The Enteral nutrition delivery system has a "smart" nasogastric tube that is equipped with sensors to provide information about the location of the tube tip relative to the stomach and monitor. Together, the sensors and the … [Read more...] about FDA clears Gravitas Medical’s smart feeding tube
Getinge wins FDA PMA for iCast covered stent
Getinge recently announced its iCast covered stent received FDA premarket approval to treat patients with iliac arterial occlusive disease. The iCast covered stent is a clinically-evaluated balloon expandable polytetrafluoroethylene-covered stent. It is delivered using a catheter to hold open and support the walls of structures within the body. … [Read more...] about Getinge wins FDA PMA for iCast covered stent
FDA clears Perfuze’s Millipede access catheter
Perfuze recently announced that it received FDA 510(k) clearance for its Millipede 088 access catheter. The Galway, Ireland-based company designed Millipede 088 to facilitate the safe insertion and guidance of microcatheters for neurointerventional or diagnostic procedures. The company hopes the device will advance all aspects of stroke … [Read more...] about FDA clears Perfuze’s Millipede access catheter
FDA clears single-use endotherapy device from Lumendi
Lumendi today announced it received FDA 510(k) clearance for two of its single-use, disposable endotherapy devices. The Westport, Connecticut-based company received FDA clearance for its DiLumen EZ¹ single-use, disposable end-therapy device for endoscopic mucosal resections and difficult colonoscopies. Its DiLumen C¹ was also cleared for use in … [Read more...] about FDA clears single-use endotherapy device from Lumendi
Abbott scores regulatory wins in electrophysiology
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
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.
