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Samenvatting: Sahajanand Medical Technologies ontvangt EU MDR-certificering voor Supraflex Cruz en de productenreeks, ter versterking van wereldwijde naleving en de veiligheid voor patiënten
MUMBAI, India--(BUSINESS WIRE)--Sahajanand Medical Technologies Limited (SMT), een toonaangevende fabrikant van cardiovasculaire medische hulpmiddelen, maakte vandaag bekend dat het onder de Medical Device Regulation van de Europese Unie (EU MDR 2017/745) certificering heeft ontvangen voor Supraflex Cruz en zijn productenreeks. SMT is een vooraanstaande speler in India’s markt van medicijnafgevende stents en staat gerangschikt onder de top vijf bedrijven in belangrijke Europese markten, waarond...
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Eccogene Receives $50 Million Milestone Payment from AstraZeneca Following Initiation of Global Phase 3 Program for Elecoglipron (AZD5004/ECC5004)
BOSTON & SHANGHAI--(BUSINESS WIRE)--Eccogene Receives $50 Million Milestone Payment from AstraZeneca Following Initiation of Global Phase 3 Program for Elecoglipron (AZD5004/ECC5004)...
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AngioDynamics to Report Fiscal 2027 First Quarter Results on October 8, 2026
LATHAM, N.Y.--(BUSINESS WIRE)--AngioDynamics, Inc. (NASDAQ: ANGO), a medical technology company focused on restoring healthy blood flow in the body's vascular system, expanding cancer treatment options and improving patient quality of life, today announced that it will report financial results for the first quarter of fiscal year 2027 before the market open on Thursday, October 8, 2026. The Company’s management will host a conference call at 8:00 am ET the same day to discuss the results. To pa...
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EU-MDR-Zertifizierung für Supraflex Cruz: Sahajanand Medical Technologies unterstreicht Compliance und Patientensicherheit
MUMBAI, Indien--(BUSINESS WIRE)--Sahajanand Medical Technologies Limited (SMT), ein weltweit führender Hersteller kardiovaskulärer Medizinprodukte, hat heute bekanntgegeben, dass Supraflex Cruz und die zugehörige Produktfamilie nach der Medizinprodukteverordnung der Europäischen Union (EU MDR 2017/745) zertifiziert wurden. SMT gehört zu den führenden Anbietern im indischen Markt für medikamentenfreisetzende Stents (Drug-Eluting Stents, DES) und zählt in wichtigen europäischen Märkten, darunter...
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Sahajanand Medical Technologies ottiene la certificazione UE MDR per Supraflex Cruz e per la serie di prodotti correlati, rafforzando la conformità globale e la sicurezza dei pazienti
MUMBAI, India--(BUSINESS WIRE)--Sahajanand Medical Technologies Limited (SMT), leader globale nella produzione di dispositivi medici cardiovascolari, oggi ha annunciato di aver ottenuto la certificazione ai sensi del Regolamento (UE) MDR 2017/745 relativo ai dispositivi medici dell'Unione europea per Supraflex Cruz e per la serie di prodotti correlati. SMT è tra i principali produttori di stent a rilascio di farmaco del mercato indiano e tra le prime cinque aziende operanti nei grandi mercati e...
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LIB Therapeutics and Sun Pharma Announce Global Licensing, Commercialization and Manufacturing Agreement for Lerodalcibep, a Novel PCSK9 Inhibitor, Ex-US and China; Lerodalcibep (Lyrokaul®) Approved in the EU
MUMBAI, India & CINCINNATI--(BUSINESS WIRE)--Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715; together with its subsidiaries and/or associated companies, “Sun Pharma”) and LIB Therapeutics Inc. (“LIB”) today announced: An exclusive licensing agreement granting Sun Pharma rights to commercialize and manufacture lerodalcibep worldwide, excluding the United States and China. Lyrokaul (lerodalcibep), a once-monthly PCSK9 inhibitor for LDL-C lo...
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Tempus Receives FDA Clearance for its ECG-MR AI Product Designed to Identify Undiagnosed Mitral Regurgitation
CHICAGO--(BUSINESS WIRE)--Tempus AI, Inc. (NASDAQ: TEM) today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Tempus ECG-MR, an AI product that analyzes standard 12-lead resting electrocardiograms (ECGs) to detect signs associated with undiagnosed moderate or severe mitral regurgitation (MR). MR is a common form of heart valve disease where blood leaks backward through the mitral valve. Because early stages are often asymptomatic or manifest as no...
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Corsera Health Named a 2026 “Endpoints 11” Honoree
BOSTON--(BUSINESS WIRE)--Corsera Health, Inc., a clinical-stage company leading the future of cardiovascular health through prediction and prevention, announced that it has been named to the 2026 “Endpoints 11” list of the most promising startups in the biopharmaceutical industry. The annual Endpoints News honor recognizes private companies that are pursuing the most ambitious scientific breakthroughs of tomorrow, backed by expert leadership and strong investor confidence. “At Corsera Health, w...
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Endpoints News Announces the 2026 Winners of the Endpoints 11 Awards, showcasing biotech’s most exciting startups
LAWRENCE, Kan.--(BUSINESS WIRE)--Endpoints News Announces the 2026 Winners of the Endpoints 11 Awards, showcasing biotech’s most exciting startups...
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Sarepta Therapeutics Announces Presentations at 2026 World Muscle Society Annual Congress
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, will present new data from its portfolio of treatments for Duchenne muscular dystrophy at the 31st Annual Congress of the World Muscle Society (WMS), taking place Sept. 29 - Oct. 3, in Hiroshima, Japan. Data at WMS includes a late-breaking poster presentation on delandistrogene moxeparvovec efficacy and safety in older, ambulatory Duchenne patients in Sarepta’...