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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.
Pfizer has entered into a multi-year deal with Anumana — a joint venture between the Mayo Clinic and nference, an electronic health record data company — to develop software for early detection of cardiac amyloidosis.
In another class action lawsuit involving generic EpiPens, two individuals and a health insurer have filed against Teva Pharmaceutical for allegedly making a deal with Viatris for Teva to delay marketing of its generic EpiPen in exchange for Viatris holding off marketing its generic narcolepsy competitor to Teva’s Nuvigil. Read More
Lunit’s study of 55,579 mammograms showed an increased cancer detection rate and a lower patient recall rate using the company’s Insight MMG breast cancer artificial (AI) solution than a team of two radiologists, the South Korea-headquartered company reported. Read More