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Toku Obtains CE and UKCA Marks for AI Cardiovascular Risk Assessments Through the Eye

SAN DIEGO–(BUSINESS WIRE)–Toku, Inc., a commercial medical device company specializing in AI assessment of retinal images, announced today that it has obtained CE and UKCA Marks for its patented CLAiR technology. This significant milestone underscores Toku’s commitment to maintaining the highest standards of quality and safety and allows access to […]

Boston Scientific Receives FDA Approval for FARAPULSE™ Pulsed Field Ablation System

MARLBOROUGH, Mass., Jan. 31, 2024 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) announced it has received U.S. Food and Drug Administration (FDA) approval for the FARAPULSE™ Pulsed Field Ablation (PFA) System. The FARAPULSE PFA System is indicated for the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic, paroxysmal (i.e., […]

Edwards’ EVOQUE Valve Replacement System First Transcatheter Therapy to Earn FDA Approval for Tricuspid Valve

IRVINE, Calif.–(BUSINESS WIRE)– Edwards Lifesciences Corporation (NYSE: EW) today announced the company’s EVOQUE tricuspid valve replacement system is the first transcatheter therapy to receive U.S. Food and Drug Administration (FDA) approval for the treatment of tricuspid regurgitation (TR). The EVOQUE system is indicated for the improvement of health status in patients […]

Sirius Therapeutics Begins Phase 1 Clinical Trial of Next-Generation, Long-Acting Factor XI siRNA Anticoagulant for Treatment of Thromboembolic Disorders

SAN DIEGO & SHANGHAI–(BUSINESS WIRE)– Sirius Therapeutics, announced it has dosed the first subject in a Phase 1, first-in-human clinical trial in Australia of SRSD107 on January 30th 2024, its next generation siRNA therapeutic targeting coagulation Factor XI (FXI), for the prevention and treatment of thromboembolic disorders. SRSD107 is the second clinical […]

Artivion Announces Release Date and Teleconference Call Details for Fourth Quarter and Full Year 2023 Financial Results

ATLANTA, Feb. 1, 2024 /PRNewswire/ — Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, announced today that fourth quarter and full year 2023 financial results will be released on Thursday, February 15, 2024 after the market closes. On…

Surmodics Reports First Quarter of Fiscal Year 2024 Financial Results; Updates Fiscal Year 2024 Financial Guidance

EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the healthcare industry, today reported financial results for its first quarter ended December 31, 2023, and updated its financial guidance for fiscal year ending September 30, 2024. “We delivered total revenue […]