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
Catheters
Study backs LimFlow system for treating chronic limb-threatening ischemia
LimFlow announced that new study results demonstrated statistically significant survival with its chronic limb-threatening ischemia (CLTI) treatment. Paris-based LimFlow’s results came from its Promise II U.S. pivotal trial. They were published in today’s issue of the New England Journal of Medicine (NEJM). Data demonstrated 66% amputation-free … [Read more...] about Study backs LimFlow system for treating chronic limb-threatening ischemia
Surmodics targets FDA premarket approval for drug-coated balloon in Q4
Surmodics (Nasdaq:SRDX) announced today that it received formal feedback from the FDA related to its SurVeil drug-coated balloon (DCB). Eden Prairie, Minnesota-based Surmodics gave the FDA a proposed approach to submit an amended premarket approval application for SurVeil. In January, the FDA indicated that Surmodics’ SurVeil PMA application is … [Read more...] about Surmodics targets FDA premarket approval for drug-coated balloon in Q4
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
Data backs splanchnic ablation procedure from Axon Therapies
Axon Therapies today announced positive six-month results from a trial for its proprietary splanchnic ablation for volume management (SAVM) therapy. Dr. Marat Fudim, advanced heart failure specialist at Duke University Medical Center, presented results at the Technology and Heart Failure Therapeutics (THT) Conference in Boston. The data came … [Read more...] about Data backs splanchnic ablation procedure from Axon Therapies
Kardium treats first patient in pulsed-field ablation study
Kardium announced today that it successfully treated the first patients in the PULSAR clinical study for its Globe PF pulsed-field ablation (PFA) system. Vancouver, British Columbia-based Kardium recently received FDA investigational device exemption (IDE) to conduct the study. The international, multicenter PULSAR study evaluates the safety and … [Read more...] about Kardium treats first patient in pulsed-field ablation study
Medtronic wins CE mark for Affera ablation system
Medtronic (NYSE:MDT) announced today that it received CE mark approval for its Affera mapping and ablation system. The Affera system includes the Sphere-9 catheter and Affera Prism-1 mapping software. Together, the system integrates Sphere-9 pulsed-field ablation (PFA), radiofrequency (RF) and high-density (HD) mapping. It maps and ablates … [Read more...] about Medtronic wins CE mark for Affera ablation system
FDA clears first device authorized under Safer Technologies Program
The FDA last week cleared a new gastric calibration tube, marking the first authorization of a device under the agency's Safer Technologies Program. FDA launched its Safer Technologies Program in 2021. It modeled the program on its breakthrough devices program. The Safer Technologies Program (STeP) covers devices that could improve the safety of … [Read more...] about FDA clears first device authorized under Safer Technologies Program
The biggest cardiology tech stories from ACC.23
Major medtech players presented a range of intriguing studies at a gathering of some of the biggest names in the cardiology tech space. Some of the hottest topics were covered this past week at the American College of Cardiology’s Annual Scientific Session Together With the World Congress of Cardiology (ACC.23/WCC) in New Orleans. Ablation, … [Read more...] about The biggest cardiology tech stories from ACC.23
Biosense Webster marks first cases with dual energy ablation tech
Biosense Webster today announced the first cases with its investigational Thermocool SmartTouch SF dual energy catheter for treating AFib. The system enables doctors performing an ablation to toggle between two types of energy: pulsed-field and radiofrequency. It appears to be the Johnson & Johnson MedTech subsidiary's answer to the dual … [Read more...] about Biosense Webster marks first cases with dual energy ablation tech