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Theravance Biopharma and Viatris have alleged that multiple competitors infringed on patent protections for Yupelri (revefenacin) — a combination drug-device product used to treat chronic obstructive pulmonary disease (COPD) — by developing generic versions.
New York, N.Y.-based cardiac artificial intelligence (AI) company Cleerly has partnered with ClearDATA, a data security company headquartered in Austin, Texas, to protect health data collected as part of Cleerly’s coronary analysis studies.
Insulet has completed two asset purchases that should about double the Massachusetts-based company’s portfolio of pump and automated insulin delivery (AID) technologies.
GE Healthcare is acquiring Caption Health, a California-based company that uses artificial intelligence (AI) solutions for early detection of heart disease in ultrasound scans.
Abbott is expanding its portfolio of cardiovascular devices through an $890 million purchase of St. Paul, Minn.-based Cardiovascular Systems (CSI) and its orbital atherectomy system.
Becoming — and remaining — in compliance with FDA regulations is often a result of creating and maintaining a quality culture, but measuring the maturity of that culture takes more than just looking at metrics, according to several experts in a recent FDAnews webinar.
Insulet announced that it has emailed 29,000 Omnipod insulin pump customers to advise them that some of their personal health information (PHI) — but not financial, social security number, email or password — was inadvertently shared with Insulet’s website performance and marketing partners.
Interventional devices for heart rhythm disorders and neurovascular care, device software and assays featured among the top buyout announcements of medical device companies in 2022 — led by the Johnson & Johnson (J&J) $16.6 billion Abiomed purchase.