Medtronic plc’s Evolut Low-Risk trial continued to show non-inferiority of transcatheter aortic valve replacement to surgical aortic valve replacement in terms of death or disabling stroke at five years in a late-breaking presentation at the American College of Cardiology’s Annual Scientific Session in Chicago on March 30. Read More
When every minute matters, quickly determining which patients in the emergency department need urgent care for myocardial infarction can save lives. Researchers at the University Hospital Münster in Münster, Germany, developed a deep learning model that can detect features on electrocardiograms that more accurately identifies which patients require urgent revascularization than clinicians and provides results faster than high-sensitivity troponin lab tests. Read More
Australia’s Therapeutic Goods Administration floated a draft rule on risk classification for in vitro diagnostics, which does not apply to home use tests, the subject of impending rulemaking. Read More
Peter Marks’ March 28 letter giving one week’s notice of his resignation as director of the U.S. FDA’s Center for Biologics Evaluation and Research (CBER) is sending more ripples of uncertainty throughout the industry. Marks, who has helmed CBER for nearly a decade, blamed his departure on recently confirmed Health and Human Services (HHS) Secretary Robert Kennedy, who has made a career out of his anti-vaccine stance. Read More
The use of an AI tool could speed up the time it takes to do pregnancy scans by almost half and it is still able to identify any abnormalities in the fetus, researchers found. Results from a study showed the AI tool used to assist with 20-week pregnancy scans reduced the scan length by more than 40% and still maintained the same accuracy and reliability of diagnoses. Read More
Sanofi SA gained U.S. FDA approval for fitusiran as a first-in-class siRNA therapy for hemophilia. Branded Qfitlia, the antithrombin-lowering therapy is indicated for use as a prophylactic treatment to prevent or reduce bleeding episodes in people with hemophilia A or B, with or without inhibitors. Read More
The biopharma sector is still trying to get its wind and resume its once-powerful investment ways. Medical technology has sidestepped much of biopharma’s issues by being more flexible along the development path, according to BioWorld MedTech Editor Annette Boyle in this edition of the podcast. Boyle described the current financing climate on the newest BioWorld Insider podcast and explained why the sector is performing well year to date.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbott, Biocardia, Boston Scientific, Jenavalve, Medtronic, Sensydia. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Electrocore, Embolx, Endra Life Sciences, GE Healthcare, Healwell, Nihon Medi-Physics, Siemens Healthineers, Varian Medical, Well Health. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Epitel, Novartis, Visby Medical. Read More
