Other News

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 […]

IRRAflow System Confirmed to More Effectively Remove Collected Blood and Reduce Catheter Infection Rates than Passive Drainage in Head-to-Head Analysis

Neurosurgeons from the Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, published data in the March issue of Operative Neurosurgery that compared procedural and clinical outcomes when treating chronic subdural hematomas with IRRAflow against passive drainage alone. The study demonstrated that IRRAflow’s active and automated continuous irrigation […]

Concept Medical granted Investigational Device Exemption (IDE) approval for their Magic Touch Sirolimus Coated Balloon for the treatment of Below the Knee (BTK) Arterial Disease

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 […]

Inspira™ Technologies Receives Approval from Sheba Medical Center to Conduct Clinical Study of the HYLA™ Blood Sensor

The clinical study is planned for Q1-2023 to be performed on patients undergoing open-heart surgery at Sheba Medical Center RA’ANANA, Israel, Feb. 13, 2023 /PRNewswire/ — Inspira™ Technologies OXY B.H.N. Ltd. (NASDAQ: IINN) (NASDAQ: IINNW) (the “Company” or “Inspira Technologies”), a company creating new acute respiratory care technologies, announced today that it has received approval by the Ethics Committee […]