Author: Ken Dropiewski

XyloCor Therapeutics Names Alexander Gaidamaka, PhD, Senior Vice President of Technology, Manufacturing & Quality

PHILADELPHIA–(BUSINESS WIRE)–XyloCor Therapeutics, a private clinical‑stage biopharmaceutical company focused on the development of gene therapy for unmet needs in cardiovascular disease, strengthens its leadership team with the appointment of Alexander Gaidamaka, PhD, as Senior Vice President of Technology, Manufacturing & Quality. Dr. Gaidamaka brings a wealth of product development, regulatory […]

Shockwave Medical Announces That CMS Has Created New Codes for Intravascular Lithotripsy

Centers for Medicare & Medicaid Services Issues New Codes for Peripheral Intravascular Lithotripsy Performed in Hospital Outpatient and Inpatient Settings SANTA CLARA, Calif., June 08, 2020 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (Nasdaq: SWAV), a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular […]

FDA Approves Abiomed’s First-in-Human Trial of Impella ECP, World’s Smallest Heart Pump

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 […]

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 […]