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 […]
Peripheral/Endo
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 […]
Cardiovascular Systems, Inc. Announces Partnership With Innova Vascular, Inc. to Develop Full Line of Thrombectomy Devices
Mechanical and aspiration devices to treat peripheral vascular disease, deep vein thrombosis and pulmonary embolism 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 it has partnered with Innova […]
Revotek Receives Clearance from the National Health Commission of China for the World First Clinical Trial for 3D Bioprinted Stem Cell Vascular Grafts
CHENGDU, China, Feb. 21, 2022 /PRNewswire/ — Revotek announced that it has received clearance from the National Health Commission of China to begin a clinical study in the West China Hospital, Chengdu, with its first stem cell 3D bioprinting product, REVOVAS. “The clearance marks an important milestone for Revotek. We are excited to advance REVOVAS, our […]
Ra Medical Systems Provides an Update on Enrollment in Its Pivotal Atherectomy Clinical Trial
CARLSBAD, Calif.–(BUSINESS WIRE)–Ra Medical Systems, Inc. (NYSE American: RMED), a medical device company focused on developing its excimer laser system to treat vascular diseases, announces enrollment has reached 95 subjects in its pivotal clinical trial to evaluate the safety and effectiveness of the DABRA excimer laser system as an atherectomy […]



