Merit Medical Systems (Nasdaq:MMSI) announced today that it received FDA premarket approval for its Wrapsody cell-impermeable endoprosthesis. With approval, the company can begin commercializing the device in the U.S. in 2025. South Jordan, … [Read More...] about FDA approves Merit Medical’s cell-impermeable endoprosthesis
Main Content
Medical Tubing & Extrusion
FDA approves Merit Medical’s cell-impermeable endoprosthesis
Merit Medical Systems (Nasdaq:MMSI) announced today that it received FDA premarket approval for its Wrapsody cell-impermeable endoprosthesis. With approval, the company can begin commercializing the device in the U.S. in 2025. South Jordan, … [Read More...] about FDA approves Merit Medical’s cell-impermeable endoprosthesis
Roivios wins FDA IDE for renal assist device
Roivios announced that it received FDA investigational device exemption (IDE) approval to conduct a trial for its renal assist device (RAD). The company can now move forward with a pivotal trial for the JuxtaFlow RAD for treating cardiac surgery … [Read More...] about Roivios wins FDA IDE for renal assist device
Boston Scientific updates instructions for cryoablation catheters after reported deaths
The FDA issued a notice alerting customers to updates made by Boston Scientific to its PolarX cryoablation catheters. This recall involves updating instructions for use (IFU), not removing devices from the market. The FDA identified it as the most … [Read More...] about Boston Scientific updates instructions for cryoablation catheters after reported deaths
CardioFocus completes first-in-human pulsed-field ablation case in investigational trial
CardioFocus announced today that investigators completed the first series of treatments in a study of its OptiShot pulsed-field ablation system. The VISION AF clinical trial evaluates OptiShot as a treatment for paroxysmal AFib. Dr. Vivek Reddy of … [Read More...] about CardioFocus completes first-in-human pulsed-field ablation case in investigational trial
First Look: Flow Medical’s next-generation thrombolysis catheter for pulmonary embolism
Flow Medical is developing a thrombolysis catheter to improve the treatment of blood clots in pulmonary embolism patients. The Chicago-based startup designed its minimally invasive system with a novel nitinol scaffold that perforates blood clots … [Read More...] about First Look: Flow Medical’s next-generation thrombolysis catheter for pulmonary embolism
Adagio Medical picks medtech veteran Todd Usen as new CEO
Adagio Medical (Nasdaq:ADGM) announced today that it appointed Todd Usen as its new CEO and board director. Usen's appointment follows the departure of Olav Bergheim, the company's founder, CEO and board chair, effective Dec. 13. The company … [Read More...] about Adagio Medical picks medtech veteran Todd Usen as new CEO
FastWave raises $19M for IVL platform
FastWave Medical announced today that it closed an oversubscribed funding round worth proceeds of $19 million. Minneapolis-based FastWave, which develops intravascular lithotripsy (IVL) technologies, said the funding brings it to more than $40 … [Read More...] about FastWave raises $19M for IVL platform
