XCath Robotics has FDA Breakthrough Device Designation for its in-development Iris surgical robotic system for mechanical thrombectomy to treat acute ischemic stroke. Houston-based XCath says the designation provides increased opportunities to interact with FDA experts and receive support during the regulatory development and review process for … [Read more...] about XCath Robotics receives FDA breakthrough nod for Iris system
FDA Breakthrough Designation
Medtronic wins expanded indication in Europe for Affera to treat VT
Medtronic (NYSE: MDT) has won an expanded CE mark indication for its Affera mapping and ablation system with Sphere-9 catheter to treat ventricular arrhythmias. The expanded indication, announced today, includes ventricular tachycardia (VT) and premature ventricular complexes (PVCs). According to Medtronic, the Sphere-9 catheter is the first … [Read more...] about Medtronic wins expanded indication in Europe for Affera to treat VT
Airiver Medical wins FDA breakthrough nod for drug-coated balloon, treats first patient
Airiver Medical announced today that it received FDA breakthrough device designation for its pulmonary drug-coated balloon (DCB). Additionally, Airiver announced the first treated patients in a clinical trial for the DCB. The Brooklyn Park, Minnesota-based company designed its DCB to treat central airway stenosis. Central airway stenosis … [Read more...] about Airiver Medical wins FDA breakthrough nod for drug-coated balloon, treats first patient
Portal Diabetes earns FDA breakthrough nod for implantable insulin pump
Portal Diabetes announced today that it received FDA breakthrough device designation for its implantable insulin pump system. The Westfield, Indiana–based company can now begin a Phase 1 study to evaluate its proprietary, temperature-stable insulin. It aims to deliver a functional cure for type 1 diabetes. Portal Diabetes developed its … [Read more...] about Portal Diabetes earns FDA breakthrough nod for implantable insulin pump
Amplifi Vascular wins FDA breakthrough nod for vein dilation system
Amplifi Vascular announced that it received breakthrough device designation for its Amplifi Vein Dilation System. The St. Louis-based company also picked up Category B assignment from the Centers for Medicare & Medicaid Services (CMS). It said the two nods mark "a pivotal step" in its mission to address critical healthcare needs. Amplifi … [Read more...] about Amplifi Vascular wins FDA breakthrough nod for vein dilation system
Abbott gets FDA breakthrough nod for dual-energy ablation catheter
An Abbott [WtwhTicker symbol="ABT"](NYSE: ABT)[/WtwhTicker] official posted on social media to announce FDA breakthrough device designation for a new ablation catheter. Abbott SVP Uri Yaron said on LinkedIn that the FDA granted the breakthrough nod for the TactiFlex Duo Sensor-Enabled catheter. The catheter features a dual-energy modality for the … [Read more...] about Abbott gets FDA breakthrough nod for dual-energy ablation catheter
Orchestra BioMed wins FDA IDE for sirolimus-angioballoon
Orchestra BioMed (Nasdaq:OBIO) announced today that it received FDA investigational device exemption (IDE) for its Virtue drug-coated balloon. It marks the second major regulatory milestone for Orchestra BioMed in just a week. The company last week picked up FDA breakthrough device designation for its atrioventricular interval modulation (AVIM) … [Read more...] about Orchestra BioMed wins FDA IDE for sirolimus-angioballoon
CereVasc wins FDA breakthrough nod for eShunt system
CereVasc announced today that it received FDA breakthrough device designation for its eShunt system for treating normal pressure hydrocephalus (NPH). The company said data generated during pilot clinical studies of the device supported the breakthrough device designation. This designation enables priority review and enhanced communication with … [Read more...] about CereVasc wins FDA breakthrough nod for eShunt system
SafeGuard Surgical wins FDA breakthrough nod for biodegradable stent backed by NFL QB
SafeGuard Surgical announced today that the FDA granted breakthrough device designation to its LeakGuard biodegradable stent. Along with the regulatory milestone, the company announced that it completed its Series A funding round. Tom Pepin, principal at Tapper Ventures, led the financing. NFL quarterback Jameis Winston is also one of the first … [Read more...] about SafeGuard Surgical wins FDA breakthrough nod for biodegradable stent backed by NFL QB
