Jupiter Endovascular announced today that its Vertex catheter received FDA 510(k) clearance for the insertion of endovascular devices. According to the FDA 510(k) database, the agency received Jupiter Endovascular's submission on June 30. It delivered the clearance on Sept. 12. The company took to LinkedIn to announce the regulatory … [Read more...] about Jupiter Endovascular wins FDA clearance for Vertex catheter
510(k)
Kardium gets FDA green light for Globe pulsed field ablation system
Kardium announced today that the FDA granted premarket approval (PMA) for its Globe pulsed field ablation (PFA) system. Along with the PMA, the FDA granted 510(k) clearance for the Globe introducer sheath and Globe pulsed field mapping software. With the FDA nod, Kardium joins the hot U.S. PFA market that includes major medtech names like … [Read more...] about Kardium gets FDA green light for Globe pulsed field ablation system
FDA clears Imperative Care Symphony thrombectomy system for pulmonary embolism
Imperative Care announced today that the FDA granted 510(k) clearance for its Symphony thrombectomy system to treat pulmonary embolism (PE). The clearance expands the use of Symphony, which previously served as a treatment for venous thrombosis, to PE. It delivers a comprehensive solution for treating the full spectrum of venous thromboembolism … [Read more...] about FDA clears Imperative Care Symphony thrombectomy system for pulmonary embolism
EvoEndo earns expanded FDA clearance for gastroscope
EvoEndo announced today that it received expanded FDA clearance for its Model LE gastroscope, covering patients of all ages. Denver-based EvoEndo's offering now covers neonates to adults, expanding the previous indication for patients aged five and older. The company says its system has been the only option available for sedation-free transnasal … [Read more...] about EvoEndo earns expanded FDA clearance for gastroscope
Stereotaxis gets FDA green light for robotic electrophysiology mapping catheter
Stereotaxis (NYSE:STXS) announced today that it received FDA 510(k) clearance for its Magic Sweep navigation catheter. The company touts Magic Sweep as the world's first robotically navigated high-density electrophysiology (EP) mapping catheter. High-density mapping enhances cardiac ablation procedures through more efficient, detailed and precise … [Read more...] about Stereotaxis gets FDA green light for robotic electrophysiology mapping catheter
Imperative Care wins FDA nod for new Zoom 7X catheter
Imperative Care announced today that it received FDA 510(k) clearance for its novel Zoom 7X catheter for aspiration thrombectomy procedures. The company also reported the first patient cases with its latest advancement for ischemic stroke treatment. Campbell, California-based Imperative Care said it marks the first catheter to incorporate its … [Read more...] about Imperative Care wins FDA nod for new Zoom 7X catheter
Johnson & Johnson MedTech gets updated FDA nod for Varipulse PFA
Johnson & Johnson MedTech today announced FDA approval for an update to its Varipulse platform's irrigation flow rate. The company said the update to its pulsed field ablation (PFA) platform reflects its commitment to the evolution of PFA innovation. Its update came on the back of real-world clinical practice. Johnson & Johnson MedTech's … [Read more...] about Johnson & Johnson MedTech gets updated FDA nod for Varipulse PFA
FDA expands clearance for Inquis Medical’s Aventus thrombectomy system
Inquis Medical announced today that the FDA granted expanded 510(k) clearance for its Aventus thrombectomy system. The expanded clearance means Aventus now has an indication to treat pulmonary embolism (PE). It comes around a month after the Menlo Park, California–based company shared positive study data for Aventus in PE. The study successfully … [Read more...] about FDA expands clearance for Inquis Medical’s Aventus thrombectomy system
Route 92 Medical wins FDA nod for reperfusion system, reports positive study findings
Route 92 Medical announced today that it received FDA 510(k) clearance for its HiPoint reperfusion system. San Mateo, California-based Route 92’s HiPoint system includes the HiPoint 88 system powered by Tenzing 8, featuring the Monopoint approach. The company says it became the first neurovascular intervention company to win clearance for direct … [Read more...] about Route 92 Medical wins FDA nod for reperfusion system, reports positive study findings
Luma Vision wins FDA clearance for cardiac visualization platform
Luma Vision recently announced that the FDA has cleared its Verafeye catheter-based cardiac imaging system. The company — based in Dublin, Ireland, and Munich, Germany — describes Verafeye as a novel catheter-based imaging system that provides real-time, two and four-dimensional, 360-degree visualization, enhancing clinician precision and … [Read more...] about Luma Vision wins FDA clearance for cardiac visualization platform
