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
510(k)
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
FDA clears Surmodics’ Pounce XL thrombectomy system
Surmodics (Nasdaq:SRDX) announced today that it received FDA 510(k) clearance for its Pounce XL thrombectomy system. The FDA indicated Pounce XL for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature in vessels 5.5–10 mm in diameter. That makes it suitable for iliac, femoral, and other arteries within this … [Read more...] about FDA clears Surmodics’ Pounce XL thrombectomy system
Olympus’ Odin Medical wins FDA nod for first cloud-based AI endoscopy system for colonoscopy
Olympus announced today that its Odin Medical unit received FDA 510(k) clearance for its Caddie computer-aided detection (CADe) device. The cloud-based AI technology assists gastroenterologists in detecting suspected colorectal polyps during colonoscopy procedures. Olympus says its the first cloud-based AI technology for this purpose. It could … [Read more...] about Olympus’ Odin Medical wins FDA nod for first cloud-based AI endoscopy system for colonoscopy
FDA clears Siemens Healthineers’ AI-powered cardiovascular ultrasound and catheter
Siemens Healthineers announced today that it received FDA clearance for its Acuson Origin ultrasound system and AcuNav Lumos 4D ICE catheter. Acuson Origin, a new, dedicated cardiovascular ultrasound, includes AI-powered features. It can help physicians perform cardiac procedures more efficiently in the areas of diagnostics, structural heart … [Read more...] about FDA clears Siemens Healthineers’ AI-powered cardiovascular ultrasound and catheter
Pentax wins FDA nod for duodenoscope with new sterilization tech
Pentax Medical announced today that the FDA cleared its DEC duodenoscope compatibility with the Sterrad 100NX sterilizer. Advanced Sterilization Products (ASP) develops Sterrad as its flagship product. Together, the companies aim to address the ongoing challenges of duodenoscope reprocessing. They hope to reduce the risk of cross-contamination … [Read more...] about Pentax wins FDA nod for duodenoscope with new sterilization tech
