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
510(k)
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
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
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
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
Imperative Care wins FDA clearance for Zoom stroke treatment
Imperative Care announced today that it has secured FDA 510(k) clearance for its Zoom comprehensive stroke thrombectomy system. According to Campbell, California–based Imperative Care, the Zoom system is the first such system to include large-bore .088-in. catheters indicated for both access and aspiration when used with one of the company's … [Read more...] about Imperative Care wins FDA clearance for Zoom stroke treatment
Pentax wins FDA nod for new models of endoscopes
Pentax Medical announced today that it earned FDA 510(k) clearance for new models of its i20c video endoscope series. The new models — the Video Colonoscope EC34-i20cL, Video Upper GI Scope EG27‑i20c and Right/Left Wheel Extender OE-B17 — work in combination with the Pentax Medical Inspira Video Processor EPK-i8020c. They support healthcare … [Read more...] about Pentax wins FDA nod for new models of endoscopes
InnoCare Urologics wins FDA nod for urinary safety catheter
InnoCare Urologics announced today that it received FDA 510(k) clearance for its novel urinary safety catheter. The Miami-based company says it marks the first-ever FDA clearance under a new code for urinary catheters with safety features. InnoCare designed its Egress safety catheter to eliminate the injuries that occur when traditional … [Read more...] about InnoCare Urologics wins FDA nod for urinary safety catheter
Vantis Vascular wins FDA nod for integrated microcatheter guide extension system
Vantis Vascular announced today that it received FDA 510(k) clearance for its CrossFast integrated microcatheter guide extension system. San Jose, California-based Vantis develops the CrossFast system along with the CrossShock intravascular lithotripsy (IVL) system. It designed CrossFast to help physicians perform faster, easier and safer … [Read more...] about Vantis Vascular wins FDA nod for integrated microcatheter guide extension system
