Company Funded Through Results of U.S. Early Feasibility Study of DurAVR™ BRISBANE, Australia and EAGAN, Minn.–(BUSINESS WIRE)–Anteris Technologies Ltd (ASX: AVR), a structural heart company developing DurAVR™, the world’s only balloon-expandable, 3D single-piece biomimetic aortic valve, announced today the completion of a A$35M equity fundraising initiated on February 9th 2023. In […]
Author: Ken Dropiewski
Verve Therapeutics Announces VERVE-101 Awarded Innovation Passport by the UK MHRA for the Treatment of Heterozygous Familial Hypercholesterolemia
BOSTON, Feb. 14, 2023 (GLOBE NEWSWIRE) — Verve Therapeutics, Inc., a clinical-stage biotechnology company pioneering a new approach to the care of cardiovascular disease with single-course gene editing medicines, today announced that VERVE-101 has been awarded the Innovation Passport for the treatment of heterozygous familial hypercholesterolemia (HeFH) under the Innovative Licensing […]
AnaBios Boosts Discovery of Safer, More Effective Medicines With License From the University of Louisville
The agreement will drive the discovery of more effective treatments for cardiovascular disease and development of safer drugs with the preclinical implementation of advanced human heart models SAN DIEGO, Feb. 14, 2023 (GLOBE NEWSWIRE) — AnaBios, a preclinical contract research organization that provides ex vivo human platforms to de-risk new […]
InspireMD Announces Hiring of Medical Device Commercial Veteran Shane Gleason as General Manager of North America and VP of Global Marketing
Seasoned veteran in vascular space adds significant expertise in U.S. commercial market readiness and global strategic marketing TEL AVIV, Israel, Feb. 14, 2023 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that it has hired […]
Cardiac AI-Pioneer Cleerly Partners with ClearDATA to Protect Patient Data
Cleerly revolutionizes precision healthcare by leveraging secure patient imaging for AI interpretation AUSTIN, Texas, Feb. 14, 2023 (GLOBE NEWSWIRE) — ClearDATA®, healthcare’s most comprehensive managed cloud, compliance and cyber defense provider, today announced a partnership with Cleerly, the company leveraging artificial intelligence (AI) to forge a new standard of prevention and care […]
Curi Bio Names Nicholas A. Geisse, Ph.D., as New Chief Executive Officer
Dr. Geisse brings 15 years of life science experience after having led scientific strategy for Curi Bio since 2017. SEATTLE–(BUSINESS WIRE)–Curi Bio, a leading developer of human stem cell-based platforms for drug discovery, today announced the appointment of Nicholas A. Geisse, Ph.D. as Chief Executive Officer, effective immediately. Dr. Geisse […]
Athersys Granted Clinical Type B Meeting with FDA for MASTERS-2 Clinical Trial Protocol Discussion
CLEVELAND–(BUSINESS WIRE)–Athersys, Inc. (NASDAQ: ATHX), a cell therapy and regenerative medicine company developing MultiStem® (invimestrocel) for critical care indications, announced today that the Company has been granted a clinical Type B meeting with the U.S. Food & Drug Administration (FDA). The Company was previously granted Regenerative Medicine Advanced Therapy (RMAT) and […]
Guerbet Announces Commercial Launch and First Patient Dosing of Elucirem™ (Gadopiclenol) Injection, a Novel New Macrocyclic GBCA for Use in Contrast-Enhanced Magnetic Resonance Imaging (MRI)
First dosage administered at the Hospital of the University of Pennsylvania following FDA approval Elucirem™ has the highest relaxivity compared to other non-specific GBCAs (gadolinium-based contrast agents) 1 Elucirem™ requires only half the gadolinium dose of conventional non-specific GBCAs, addressing practitioners’ concerns about gadolinium exposure. 2,3 PRINCETON, N.J., Feb. 13, 2023 /PRNewswire/ — Guerbet, a global leader in […]
Hyperfine, Inc. Announces FDA Clearance for Improved AI-Powered Software and Expanded Field of View for the Swoop® Portable MR Imaging® System
Latest Swoop® software improves image quality for DWI imaging of the brain GUILFORD, Conn., Feb. 13, 2023 (GLOBE NEWSWIRE) — Hyperfine, Inc., the groundbreaking medical device company that created the Swoop® system, the world’s first FDA-cleared portable magnetic resonance imaging (MRI) device for imaging of the brain, today announced the U.S. […]
MCRA Assists TriReme Medical with Obtaining FDA Premarket Approval of Cardiovascular Balloon Catheter
WASHINGTON, Feb. 13, 2023 /PRNewswire/ — MCRA, LLC, a leading medical device focused regulatory advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory Affairs, Clinical Trial Operations, Reimbursement and Market Access, Healthcare Compliance, Cybersecurity, Quality Assurance, and Japan Distribution Logistics (DMAH) is pleased to announce its role in the […]
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