Completes the RADIANZ Radial Peripheral System™; signals Cordis’ renewed investment in innovation MIAMI LAKES, Fla., March 10, 2022 /PRNewswire/ — Cordis, a global cardiovascular technology company, today announced that the U.S. Food and Drug Administration (FDA) has approved the S.M.A.R.T. RADIANZ™ Vascular Stent System, a self-expanding stent purposefully engineered for radial peripheral procedures. […]
Peripheral/Endo
Cardiovascular Systems, Inc. Announces First In-Human Experience With Peripheral Everolimus Drug-Coated Balloon
ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today the start of enrollment in a first in-human trial of the peripheral everolimus drug-coated balloon (DCB) being developed by Chansu […]
Long-term Device Benefits Demonstrated in the Largest VasQ™ External Support Forearm Fistula Real-World Experience Published To Date
TEL AVIV, ISRAEL, March 9, 2022 /PRNewswire/ — Dr. Robert Shahverdyan, Head of Vascular Access Center at Asklepios Klinik Barmbek of Hamburg, Germany, in partnership with Dr. Dirk Hentschel, President-Elect of VASA and Interventional Nephrologist at Brigham and Women’s Hospital of Boston, MA, have recently published a retrospective analysis of 150 consecutive radiocephalic (forearm) fistula VasQ™ External Support […]
Avinger Announces Successful Completion of First Cases with the Lightbox 3 Next Generation Imaging Console
REDWOOD CITY, CA / ACCESSWIRE / February 28, 2022 / Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced that physicians in the U.S. have successfully completed first cases with its new […]
Clinical Study using QuantaFlo® published in Peer-Reviewed Journal of Vascular Surgery
Results show a positive screening of previously undetected PAD was independently associated with short-term and long-term increased risks for mortality and major adverse cardiovascular events SANTA CLARA, Calif., March 1, 2022 /PRNewswire/ — Semler Scientific, Inc. (Nasdaq: SMLR), a company that provides technology solutions to improve the clinical effectiveness and efficiency of healthcare providers, […]
Ra Medical Systems Files 510(k) Application for the DABRA Catheter with Braided Overjacket and Six-Month Shelf Life
CARLSBAD, Calif.–(BUSINESS WIRE)–Ra Medical Systems, Inc. (NYSE American: RMED), a medical device company focusing on developing its excimer laser system to treat vascular diseases, announces the filing of a 510(k) application with the U.S. Food and Drug Administration (FDA) for the company’s next-generation DABRA catheter with a braided overjacket and […]
AbbVie Seeks New Indication for IMBRUVICA® (ibrutinib) in Pediatric Patients with Chronic Graft Versus Host Disease (cGVHD)
– cGVHD is a life-threatening and rare condition that currently does not have an approved treatment for children under 12 and can occur in patients after receiving peripheral blood or bone marrow stem cell transplantation – If approved, IMBRUVICA would offer pediatric and adolescent patients the first BTKi treatment option […]
Humacyte Announces Publication of Positive Long-Term Follow-Up Data from Phase 2 Trial of HAV™ for Hemodialysis
— Five-year data demonstrate the potential of the Human Acellular VesselTM (HAV) to be a durable and safe option for vascular access for routine, long-term hemodialysis — — Results published in EJVES Vascular Forum — DURHAM, N.C., Feb. 28, 2022 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing […]
InspireMD Announces the Inclusion of its CGuard Carotid Stent in CREST-2 Trial Following FDA Approval of the Investigational Device Exemption Supplement Application
– CGuard™ Carotid Stent will now be a treatment option in the stenting plus medical therapy arm of the trial for patients – – CREST-2 Trial is sponsored by the National Institute of Neurological Disorders and Stroke (NINDS) and actively engaged at more than 140 study locations – TEL AVIV, Israel, Feb. […]
Viz.ai Receives FDA 510(k) Clearance for Viz ANEURYSM
First AI-powered cerebral aneurysm detection solution designed to facilitate population screening and enhanced care management SAN FRANCISCO–(BUSINESS WIRE)–Viz.ai, the world leader in artificial intelligence (AI) powered care coordination, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Viz ANEURYSM. The new algorithm uses AI to […]



