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. […]
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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 […]
Pharmazz, Inc. Announces US FDA Clearance for a Phase III Clinical Trial of Sovateltide (PMZ-1620) in Acute Cerebral Ischemic Stroke Patients
The primary endpoint is the proportion of patients with a good outcome as a modified Rankin Score (mRS) of 0-2 on day 90 post-randomization Sovateltide is an endothelin-B receptor agonist that has been shown to increase blood flow, inhibit apoptosis, and induce neurovascular remodeling WILLOWBROOK, III., Feb. 13, 2023 /PRNewswire/ — Pharmazz, […]
Cardiawave Granted 3 New Patents Extending Its Intellectual Property Protection for Its Technology in the United States
LEVALLOIS-PERRET, France–(BUSINESS WIRE)–Cardiawave SA, a deeptech medical device manufacturer that has developed Valvosoft®, an innovative non-invasive medical device to treat aortic stenosis, the most prevalent heart valve disease in adults, announces the issuance of 3 new patents in the United States. These patents protect Valvosoft®’s ultrasound imaging and therapy device […]
SIS Medical AG announces the US-launch and the first US-treatment with the Super-High-Pressure balloon – OPN NC® – with TWIN-Wall technology
Frauenfeld, Switzerland – February 2nd, 2023 SIS Medical AG (Swiss Interventional Systems), a globally leading developer, manufacturer and distributor of high-quality and high-performance products in the field of interventional cardiology, announces the launch of its lead product OPN NC® PTCA Dilatation Catheter with TWIN-Wall technology in the US. The product […]
ProterixBio Announces Commercial Offering of Quantitative Soluble ST2 Assay
BILLERICA, Mass., Feb. 10, 2023 /PRNewswire/ — ProterixBio, Inc. today announced the offering of the Presage® ST2 Assay as a testing service through ProterixBio’s high-complexity CLIA laboratory. This Assay has been FDA cleared for use in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure. Heart […]
VST-BIO Announces Successful Preclinical Trials in Ischemic Stroke
VST-Bio’s Collaborators Present Preclinical Trial Results at the American Heart Association International Stroke Conference in Dallas. SAN DIEGO, Feb. 10, 2023 /PRNewswire/ — VST-Bio Corp. a leader in the development of innovative biologics to treat acute and chronic cardiovascular disease, presented data from a recent large animal study performed by VST-Bio and Yale University demonstrating […]
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