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
Regulatory
Terumo Neuro wins FDA nod for first dual-layer carotid stent
Terumo Neuro (formerly MicroVention) announced today that it received FDA premarket approval (PMA) for its Carotid Stent System. Aliso Viejo, California-based Terumo Neuro says this marks the first dual-layer micromesh carotid stent approved in the U.S. It offers physicians a clinically proven option to improve patient outcomes in carotid artery … [Read more...] about Terumo Neuro wins FDA nod for first dual-layer carotid stent
Elixir Medical launches IVL system in Europe
Elixir Medical announced today that it received CE mark for its LithiX hertz contact (HC) intravascular lithotripsy (IVL) system. The Milpitas, California–based company kicked off its commercial launch for the IVL system in Europe following receipt of CE mark. Dr. Stefano Galli (Centro Cardiologico Monzino in Milan), Dr. Eric Van Belle (Lille … [Read more...] about Elixir Medical launches IVL system in Europe
FDA clears Imperative Care’s Symphony 16F 82cm catheter
Imperative Care today announced FDA 510(k) clearance of its Symphony 16 Fr 82cm catheter for venous thrombosis and announced the first successful cases. Campbell, California-based Imperative Care said the catheter joins the Symphony Thrombectomy System's 16 Fr 117 cm and 24 Fr 85 cm catheters. "The customized length of the 16 Fr 82 cm … [Read more...] about FDA clears Imperative Care’s Symphony 16F 82cm catheter
Abbott is making an IVL play with FDA IDE nod
Abbott announced today that it received FDA investigational device exemption (IDE) approval for its coronary intravascular lithotripsy (IVL) system. IDE enables the company to evaluate the system in treating severe calcification in coronary arteries prior to stenting. The company expects its TECTONIC coronary artery disease (CAD) IVL trial to … [Read more...] about Abbott is making an IVL play with FDA IDE nod
Medtronic recalls embolization device after reported deaths
The FDA deemed a recall of some Medtronic Pipeline Vantage embolization devices serious after multiple deaths related to the device. The recall involves removing Pipeline Vantage 027 device models from use and sale and updating instructions for Pipeline Vantage 021 models. Medtronic's Pipeline Vantage embolization devices with Shield Technology … [Read more...] about Medtronic recalls embolization device after reported deaths
Perfuze wins FDA nod for access catheter, raises $24M
Perfuze announced today that it received FDA 510(k) clearance for its Zipline access catheter and secured significant funding. The Galway, Ireland–based medtech company picked up about $24 million (€22 million) in a follow-on funding round. Existing investors, including Earlybird, EQT Life Sciences, Seroba and SV Health, participated in the … [Read more...] about Perfuze wins FDA nod for access catheter, raises $24M
Lungpacer wins FDA IDE for AeroNova system
Lungpacer Medical announced today that it received FDA investigational device exemption (IDE) to begin a trial for its AeroNova system. The STARI (stimulation to activate respiration) trial evaluates the feasibility of the investigational AeroNova system. It looks at the system in patients suffering from moderate to severe Acute Hypoxemic … [Read more...] about Lungpacer wins FDA IDE for AeroNova system
Stereotaxis submits pair of catheters for FDA clearance
Stereotaxis today announced it submitted its EMAGIN 5F and MAGiC catheters for FDA clearance. EMAGIN 5F, short for Endovascular Magnetic Intervention, is a 5-French diameter that navigates tortuous venous and arterial vasculature. Stereotaxis designed it to enable efficient and safe navigation to access difficult-to-reach vascular … [Read more...] about Stereotaxis submits pair of catheters for FDA clearance
Olympus has a serious endoscope guide sheath recall
The FDA today issued a notice warning of the removal of certain single-use guide sheath kits for endoscope instruments by Olympus. This recall involves removing certain devices from where they are used or sold. The FDA identified it as the most serious type of recall, as it may cause serious injury or death. Olympus warned customers to not … [Read more...] about Olympus has a serious endoscope guide sheath recall
