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CHELMSFORD, Mass.--(BUSINESS WIRE)--ZOLL®, een bedrijf van Asahi Kasei dat medische hulpmiddelen en aanverwante softwareoplossingen produceert, maakte vandaag bekend dat Zenix®, de meest klinisch geavanceerde en gebruiksvriendelijke professionele monitor/defibrillator van het bedrijf, onder de EU (Europese Unie) Verordening inzake Medische Hulpmiddelen 2017/745, doorgaans aangeduid als EU MDR (Medical Device Regulation), werd goedgekeurd. De Zenix monitor/defibrillator is een baanbrekend hulpmi...

CHELMSFORD, Massachusetts--(BUSINESS WIRE)--ZOLL®, azienda del gruppo Asahi Kasei produttrice di dispositivi medici e delle soluzioni software correlate, oggi ha reso noto che Zenix®, il suo monitor/defibrillatore professionale clinicamente più avanzato e di semplice utilizzo, ha ottenuto l'approvazione ai sensi del regolamento UE (Unione Europea) 2017/745 sui dispositivi medici, comunemente denominato EU MDR. Il monitor/defibrillatore Zenix è un dispositivo rivoluzionario che ridefinisce i con...

CHELMSFORD, Massachusetts--(BUSINESS WIRE)--ZOLL®, une société Asahi Kasei qui fabrique des dispositifs médicaux et des solutions logicielles associées, a annoncé aujourd’hui que Zenix®, son moniteur/défibrillateur professionnel le plus avancé sur le plan clinique et le plus facile à utiliser, a été homologué conformément au règlement 2017/745 de l’Union européenne (UE) relatif aux dispositifs médicaux, communément appelé MDR UE. Le moniteur/défibrillateur Zenix est un dispositif révolutionnair...

CHELMSFORD, Massachusetts--(BUSINESS WIRE)--ZOLL®, una empresa de Asahi Kasei que fabrica dispositivos médicos y soluciones de software relacionadas, ha anunciado hoy que Zenix®, el monitor/desfibrilador profesional más avanzado clínicamente y fácil de usar de la empresa, ha sido aprobado en virtud del Reglamento sobre productos sanitarios 2017/745 de la Unión Europea (UE), comúnmente conocido como MDR de la UE. El monitor/desfibrilador Zenix es un dispositivo revolucionario que redefine la efi...

CHELMSFORD, Massachusetts--(BUSINESS WIRE)--ZOLL®, ein Unternehmen der Asahi Kasei Corporation, das medizinische Geräte und zugehörige Softwarelösungen herstellt, gab heute bekannt, dass Zenix®, der klinisch fortschrittlichste und benutzerfreundlichste professionelle Monitor/Defibrillator des Unternehmens, gemäß der Medizinprodukteverordnung 2017/745 der Europäischen Union (EU), allgemein als EU MDR bezeichnet, zugelassen ist. Der Zenix-Monitor/Defibrillator ist ein bahnbrechendes Gerät, das Ef...

PHOENIXVILLE, Pa.--(BUSINESS WIRE)--Facet Life Sciences, a regulatory affairs and product development strategy partner, is proud to announce the release of the second edition of FDA and Intellectual Property Strategies for Medical Device Technologies, an updated resource for medical device innovators featuring six Facet Life Sciences experts as contributing authors. “The journey from medical device concept to commercialization has been significantly impacted by recent key shifts in the technolo...

BETHESDA, Md.--(BUSINESS WIRE)--Healthcare Innovation Catalysts, Inc. (HIC), a leading provider of regulatory affairs, clinical advisory, quality, compliance, federal partnership, and strategic advisory services to global life sciences organizations, announced today that Joseph (Joe) Biehl, has been appointed Chief Executive Officer. Mr. Biehl brings over 35 years of healthcare and life science industry experience to HIC. Mr. Biehl’s experience includes leading, directing, and managing various...

DURHAM, N.C.--(BUSINESS WIRE)--HemoSonics LLC, a medical device company focused on acute bleeding management, today announced that its Quantra® Hemostasis System for Obstetric Procedures is one of the top three finalists in the Women’s Health and Reproductive Innovations category of the world-renowned 2026 Edison Awards. The Company’s point-of-care solution received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for expanded use of its Quantra Hemostasis System with QStat® Ca...

LONDON--(BUSINESS WIRE)--Calla Lily Clinical Care, a women’s health-focused medical technology company, and Merck, a leading science and technology company, have entered a strategic collaboration to support the continued development of Callavid®, a novel platform for intravaginal drug delivery. The collaboration represents the first industry partnership for the Callavid technology. Callavid is a transformational leak-resistant medical device designed to address challenges associated with the se...

CHELMSFORD, Mass.--(BUSINESS WIRE)--ZOLL®, an Asahi Kasei company that manufactures medical devices and related software solutions, announced today that Zenix®, the company’s most clinically advanced and easy-to-use professional monitor/defibrillator, is approved under the European Union (EU) Medical Device Regulation 2017/745, commonly referred to as EU MDR. The Zenix monitor/defibrillator is a groundbreaking device that redefines efficiency, clarity, and intelligence in both EMS and hospital...