Rapid Medical announced today that it received FDA clearance for the Tigertriever 25 thrombectomy device, its latest addition to the platform. The company also reported the first clinical cases using the device in treating large vessel occlusion (LVO) stroke. Designed specifically for large clot burden in proximal vessels, Tigertriever 25 … [Read more...] about Rapid Medical earns FDA clearance for latest Tigertriever device
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Protaryx earns FDA nod for transseptal puncture device
Protaryx Medical announced that it received FDA 510(k) clearance for its proprietary Transseptal Puncture Device. Baltimore-based Protaryx said clearance marks a significant advancement in its mission to redefine safe, efficient and reproducible left heart access. for cardiac interventions. It hopes to enable broader adoption and improved … [Read more...] about Protaryx earns FDA nod for transseptal puncture device
InVera wins FDA clearance for non-thermal infusion catheter
InVera Medical announced today that it received FDA 510(k) clearance for its InVera Infusion Device. Galway, Ireland-based InVera designed its minimally invasive device to help physicians deliver treatment more effectively to diseased leg veins, including varicose veins. It aims to treat chronic venous disease (CVD), which currently faces a … [Read more...] about InVera wins FDA clearance for non-thermal infusion catheter
Perfuze wins FDA clearance for standalone aspiration catheter
Perfuze announced today that it received FDA 510(k) clearance for its Millipede88 aspiration catheter. Galway, Ireland–based Perfuze designed the catheter for rapid and complete clot removal in patients suffering from large vessel occlusion (LVO) strokes. The company aims to improve stroke treatment outcomes and reduce procedural … [Read more...] about Perfuze wins FDA clearance for standalone aspiration catheter
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
Olympus picks up pediatric indications from FDA for duo of single-use bronchoscopes
Olympus announced today that it received FDA clearance for pediatric use for two of the single-use bronchoscopes it distributes in the U.S. Center Valley, Pennsylvania-based Olympus Corp. of the Americas distributes the H-SteriScope single-use video flexible bronchoscopes in the U.S. Hunan Vathin Medical Instrument Co. manufactures the scopes. … [Read more...] about Olympus picks up pediatric indications from FDA for duo of single-use bronchoscopes
Vantive updates instructions after dialysis system tubing issue
The FDA issued a notice related to updated instructions for the Vantive Prismaflex control units after reports of a potential tubing issue. Vantive, the former kidney care unit of Baxter, issued a letter on Jan. 6 informing customers of the updated instructions. The FDA said it became aware of the "potentially high-risk device issue" related to … [Read more...] about Vantive updates instructions after dialysis system tubing issue
Boston Scientific wins FDA nod for Farapoint PFA catheter
A Boston Scientific (NYSE:BSX) executive said on social media that the company received FDA approval for its Farapoint pulsed field ablation (PFA) catheter. SVP and President of Electrophysiology, Nick Spadea-Anello, posted on LinkedIn to congratulate the company for receiving FDA approval for Farapoint. He noted that the approval "closely … [Read more...] about Boston Scientific wins FDA nod for Farapoint PFA catheter
Abbott earns FDA approval for Volt PFA system for AFib
Abbott (NYSE:ABT) announced today that the FDA approved its Volt pulsed field ablation (PFA) system to treat patients with AFib. The regulatory nod brings Abbott Volt to the U.S. PFA market to compete against the likes of Medtronic, Boston Scientific, Johnson & Johnson MedTech and Kardium. It follows CE mark approval for Volt earlier this … [Read more...] about Abbott earns FDA approval for Volt PFA system for AFib
Medtronic, J&J MedTech both get FDA nods for liquid embolic systems
Medtronic (NYSE: MDT) and Johnson & Johnson (NYSE: JNJ) have both announced recent regulatory milestones for liquid embolic systems. Both picked up FDA approvals for the treatment of symptomatic subacute and chronic subdural hematoma (cSDH) as an adjunct to surgery. Earlier this month, Medtronic said the FDA granted the indication for its … [Read more...] about Medtronic, J&J MedTech both get FDA nods for liquid embolic systems
