Press Release: Sanofi delivers first medicines from Global Health Unit’s Impact brand portfolio

Sanofi delivers first medicines from Global Health Unit’s Impact brand portfolio Paris, October 19, 2023. Sanofi has delivered the first medicines from its Global Health Unit’s not-for-profit Impact brand portfolio to the Republic of Djibouti. Enoxaparin Sodium Impact is an anticoagulant medicine indicated for the treatment of venous thromboembolism including […]

Cardio Flow, Inc., Announces U.S. Food and Drug Administration (FDA) 510(k) Clearance for its FreedomFlow® Orbital Atherectomy Peripheral Platform

ST. PAUL, Minn.–(BUSINESS WIRE)–Cardio Flow, Inc., a privately held medical device company and developer of minimally invasive devices to treat peripheral artery disease (PAD), today announced it recently received U.S. Food and Drug Administration (FDA) 510(k) clearance for the company’s FreedomFlow Orbital Atherectomy Peripheral Platform. “Critical Limb Ischemia: Volume 1. […]

Alcami Supports Phase II/III Trial Supply of the Nectero EAST® System

WILMINGTON, N.C., Oct. 17, 2023 /PRNewswire/ — Alcami Corporation (“Alcami”), a leading contract development and manufacturing organization (CDMO), today welcomed the recent announcement by Nectero Medical that they have received clearance from the U.S. Food and Drug Administration of their IND application to initiate Phase II/III trial of the Nectero Endovascular Aneurysm […]

Evident Vascular Exits Stealth with $35 Million Series A Funding to Develop Intravascular Imaging Platform

SAN JOSE, Calif.–(BUSINESS WIRE)–Evident Vascular, Inc., a medical technology startup developing a next-generation intravascular ultrasound (IVUS) platform leveraging artificial intelligence to enable superior imaging and streamlined workflows, announced today that it has launched with a $35 million Series A financing from Vensana Capital®. “Legacy IVUS platforms were originally designed primarily for […]

InspireMD Supports CMS’ Final National Coverage Determination (NCD) Expanding Coverage of Carotid Stenting (CAS) to Include Both Asymptomatic and Standard Risk Patients

TEL AVIV, Israel and MIAMI, Oct. 12, 2023 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced its support for the Centers for Medicare and Medicaid Services (CMS) final National Coverage Determination (NCD) which expands coverage […]

Alio’s Remote Monitoring Platform Now Notifies Clinicians of Atypical Acoustic Data from Patients with Vascular Access

BROOMFIELD, Colo., Sept. 28, 2023 /PRNewswire/ — Today, Alio, Inc. announces the release of a new feature for its remote monitoring platform which notifies clinical care teams when there is a gap in typical acoustic data from a patient’s vascular access site. While the platform was FDA-cleared in March of this year to […]

The VasQ™ External Support Now FDA Cleared for Use in Creating Arteriovenous Fistulas

TEL AVIV, Israel, Sept. 27, 2023 /PRNewswire/ — Laminate Medical Technologies (Laminate) has announced their flagship device, the VasQ External Vascular Support, has been cleared by the FDA for use to create arteriovenous fistulas (AVFs) for dialysis access. The device, designated by the FDA as a Breakthrough Technology, was cleared based on […]

FDA Approves LimFlow System in Patients With Chronic Limb-Threatening Ischemia and No Suitable Endovascular or Surgical Revascularization Options

PARIS & SAN JOSE, Calif.–(BUSINESS WIRE)–LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), announced today that the U.S. Food and Drug Administration (FDA) has approved the LimFlow System to help people with […]

Humacyte Announces Positive Top Line Results from Phase 2/3 Trial of Human Acellular Vessel™ (HAV™) in Treatment of Patients with Vascular Trauma

DURHAM, N.C., Sept. 12, 2023 (GLOBE NEWSWIRE) —  Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced positive top line results from its V005 Phase 2/3 trial of the Human Acellular Vessel (HAV) in vascular trauma repair. The single-arm clinical […]