Coronary/Structural Heart

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 […]

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 […]

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 […]

Heartseed and Novo Nordisk announce first patient dosed in clinical study with HS-001 – a cell therapy designed to restore heart function in people with advanced heart failure

HS-001 consists of clusters of purified heart muscle cells derived from induced pluripotent stem cells (iPSCs). Clinical phase 1/2 study (LAPiS Study) will enrol 10 patients with advanced heart failure caused by ischaemic heart disease. Tokyo, Japan and Bagsværd, Denmark, 10 February 2023 – Heartseed Inc. (Heartseed) and Novo Nordisk A/S today announced that Heartseed has successfully dosed the first patient in […]

Philips and TriHealth announce multi-year partnership at heart of new TriHealth Heart & Vascular Institute on the campus of Bethesda North Hospital

With access to innovative healthcare technologies, clinicians can continue to provide exceptional care to local and surrounding communities and deliver on Quadruple Aim Amsterdam, the Netherlands and Cincinnati, Ohio, USA – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, has entered into a long-term strategic partnership with TriHealth, […]

BioAro is the first Canadian company to launch comprehensive genetic testing panels for various heart diseases

CALGARY, AB, Feb. 9, 2023 /PRNewswire/ – Cardiovascular diseases affects over 3 million Canadians, and over 750, 000 Canadians are living with heart failure. Almost 1 in 3 Canadians are touched by heart failure, and over 100,000 new Canadians are diagnosed with heart failure every year. The death rate is 3 times higher […]

Sequana Medical announces the successful completion of pre-clinical studies with its second-generation DSR product for congestive heart failure

Data from GLPi animal studies demonstrate safety of second-generation DSRii product (DSR 2.0) Data from Phase 1 study of DSR 2.0 in Mexico (CHIHUAHUA) and INDiii filing to US FDA expected in Q1 2023 Planning to start MOJAVE, a US Phase 1/2a randomized controlled multi-center study of DSR 2.0, in […]

LivaNova Initiates Limited Commercial Release in Europe of the Essenz Perfusion System for Cardiopulmonary Bypass Procedures

LONDON–(BUSINESS WIRE)–LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology and innovation company, today announced the start of a limited commercial release for the Essenz™ Perfusion System*. The release has been initiated in select centers throughout Europe, following a successful clinical experience in two major centers, Catharina Hospital in Eindhoven, Netherlands […]