TAMPA, Fla., Feb. 13, 2023 /PRNewswire/ — Concept Medical Inc. (CMI), on 9th February 2023, received the Investigational Device Exemption (IDE) from the US FDA, for its Magic Touch Sirolimus Coated Balloon. The Magic Touch PTA Sirolimus Coated Balloon Catheter is indicated for the treatment of Below the Knee (BTK) atherosclerotic lesions in Peripheral Arterial Disease. CMI […]
Peripheral/Endo
Northeast Scientific Inc. awarded 510(k) clearance to reprocess the Eagle Eye Platinum RX Digital IVUS Catheter
WATERBURY, Conn., Feb. 06, 2023 (GLOBE NEWSWIRE) — Northeast Scientific Inc., the pioneers in reprocessing single use peripheral vascular catheters, announced this week it has received FDA 510(k) clearance for reprocessing the Philips IVUS Eagle Eye Platinum RX Digital catheter. CEO and Founder, Craig Allmendinger shared his thoughts on the […]
VentureMed Group Raises Bridge Financing and Embarks on 2023 Objectives
MINNEAPOLIS, Jan. 31, 2023 /PRNewswire/ — VentureMed Group, Inc., a privately held medical device innovator in access management for arteriovenous (AV) fistulas and grafts and vessel preparation for interventional treatment of peripheral arterial disease (PAD) announced today that the company has raised bridge financing to support its 2023 objectives. Endeavour Vision and RiverVest Venture […]
Updated SCAI Guidance Includes Coronary IVL as a Treatment Option in All U.S. Catheterization Labs Regardless of Surgical Backup Status
Guidance Expands Number of Hospitals that Can Access IVL to Include Sites Where Calcium Modification Tools Were Previously Not Recommended SANTA CLARA, Calif., Jan. 31, 2023 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, today […]
Cagent Vascular announces superior lumen gain, greater volumetric blood flow using Serration Angioplasty: A sub-analysis of the PRELUDE BTK study
WAYNE, Pa.–(BUSINESS WIRE)–Cagent Vascular, the exclusive developer of Serration Angioplasty (Serranator®), announced the results of a comparative sub-analysis of the PRELUDE-Below-the-Knee (BTK) study versus Plain Old Balloon Angioplasty (POBA). The study was led by Dr. Marianne Brodmann (Radcliffe Cardiology, Graz, Austria). This sub-analysis compared their PRELUDE-BTK subset to a consecutive […]
Humacyte Publication in the Journal of Vascular Surgery – Vascular Science Reports the Human Acellular Vessel™ (HAV™) Remains Durable at Six Years in Patients with Peripheral Artery Disease
– HAVs observed to provide long-term perfusion to patients with critical limb ischemia – 3D Angiograms show mechanical durability of engineered human blood vessels DURHAM, N.C., Jan. 24, 2023 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissues and advanced tissue […]
Surmodics Provides Regulatory Update Related to its FDA Premarket Approval Application for the SurVeil™ Drug-Coated Balloon
EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced it has received a letter from the U.S. Food and Drug Administration (FDA; the Agency) related to its premarket approval (PMA) application for the SurVeil™ drug-coated […]
Differentiated Capabilities of Surmodics’ Crystalline Drug Release Platform for Sirolimus-Coated Balloons Presented at ISET Conference
Surmodics’ proprietary Crystalline Drug Release (CDR) platform enhances sirolimus stability, transfer, and retention in tissue CDR discussed in connection with 12-month data from Surmodics’ SWING trial of the Sundance™ Sirolimus-Coated Balloon January 19, 2023 08:30 AM Eastern Standard Time EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX) (the “Company”), a leading provider of […]
Inari Medical Announces First Patient Enrolled in the DEFIANCE Trial, Randomized Controlled Trial Evaluating Clinical Outcomes of the ClotTriever® System in Deep Vein Thrombosis
IRVINE, Calif., Jan. 12, 2023 (GLOBE NEWSWIRE) — Inari Medical, Inc. (NASDAQ: NARI) (“Inari”) a medical device company with a mission to treat and transform the lives of patients suffering from venous and other diseases, today announced that the first patient has been enrolled in DEFIANCE, a prospective randomized controlled […]
Avinger Announces 510(k) Filing of Pantheris LV
Pantheris LV Represents the Next-Generation of Onboard Image-Guided Technology for the Treatment of Peripheral Artery Disease REDWOOD CITY, CA / ACCESSWIRE / January 11, 2023 / 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 […]



