DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (NASDAQ: ABMD) announces the United States Food and Drug Administration (FDA) has approved the company’s investigational device exemption application to start an early feasibility study with a first-in-human trial of the 9 French (Fr) Impella ECP™ heart pump. Impella ECP, which stands for expandable cardiac power, will be […]
Other News
Edwards SAPIEN 3 Transcatheter Heart Valve Receives Approval In China
IRVINE, Calif., June 8, 2020 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that it has received Chinese regulatory approval for the Edwards SAPIEN 3 transcatheter heart valve for the treatment of patients suffering from severe, symptomatic aortic […]
Surmodics Receives CE Mark for its SurVeil™ Drug Coated Balloon
Next generation device adds new technology to how physicians approach treatment of PAD EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced it has received CE Mark Certification in the European Union for its SurVeil™ […]
Medtronic Resolute Onyx™ DES Receives First and Only One-Month DAPT Indication for High Bleeding Risk Patients in Europe
DUBLIN, June 05, 2020 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received CE (Conformité Européenne) Mark for a one-month dual antiplatelet therapy (DAPT) indication for high bleeding risk (HBR) patients implanted with the Resolute Onyx™ Drug-Eluting Stent (DES). For HBR patients, whose bleeding risk may be increased by taking longer DAPT […]
InspireMD, Inc. Announces Underwriter Exercise of Over-Allotment Option in Full and Closing of $11.5 Million Follow-On Underwritten Public Offering
TEL AVIV, Israel, June 08, 2020 (GLOBE NEWSWIRE) — InspireMD, Inc. (NYSE American: NSPR), the developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease, announced today the closing, on June 5, 2020, of its $11.5 million follow-on underwritten public offering, which included […]
Mynomx Announces Scientific Validation of Its Cardiometabolic Risk Engines for Assessing Risk of COVID-19 in Populations
PALO ALTO–(BUSINESS WIRE)–Mynomx Inc. (formerly Precision Wellness, Inc.), a Silicon Valley-based company at the intersection of next-generation AI analytics and the latest medical and nutrition science, today announced the scientific validation of their cardio and metabolic predictive models against 2.5M patient population through two sponsored research studies with Stanford University. […]
MedHub AutocathFFR Awarded AMAR Certification, Israel’s Medical Device Regulatory Approval
AutocathFFR, the company’s first commercial product, is a transformative cardiac diagnosis system. TEL AVIV, Israel, June 4, 2020 /PRNewswire/ — MedHub Ltd., a medical technology company focused on developing and commercializing AI powered medical solutions that aid in the diagnosis of cardiac disease, announced that is has gained AMAR approval for its […]
Espero BioPharma, Inc. Expands Collaboration Effort for Tecarfarin
JACKSONVILLE, Fla. and IRVINE, Calif., June 4, 2020 /PRNewswire/ — Espero BioPharma, Inc., a pharmaceutical company focused on the development of therapeutics for unmet needs in thrombosis and cardiac rhythm control, today expanded a collaborative partnering effort for its lead product candidate tecarfarin. Tecarfarin is a Phase III-ready, vitamin K antagonist, taken once a day […]
Novadoz Pharmaceuticals FDA Approvals of Oseltamivir and Dofetilide Continues the Company’s Rise in the Generic Market
PISCATAWAY, N.J., June 4, 2020 /PRNewswire/ — Novadoz Pharmaceuticals, the U.S based sales & marketing affiliate for MSN Labs, located in Hyderabad India, recently received FDA approval for their generic versions of Oseltamivir Phosphate Capsules and Dofetilide Capsules. The company was notified earlier this year, that Dofetilide 125mcg, 250mcg, 500mcg capsules, AB rated to […]
Neovasc Announces Closing of Final Convertible Debt Issuance for Gross Proceeds of US$5.0 Million
VANCOUVER and MINNEAPOLIS, MN, June 04, 2020 (GLOBE NEWSWIRE) — via NEWMEDIAWIRE — Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies, and minimally invasive devices for the treatment of refractory angina, announced today that, further to its press release dated […]



