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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
California’s HeartVista has teamed with Germany-based Siemens Healthineers to co-market an automated cardiac magnetic resonance (CMR) imaging exam platform that takes up less scanner time and requires no additional training for technicians. Read More
Lantheus, which specializes in radiopharmaceutical diagnostic and therapeutic products, will pay $260 million in upfront license fees — with potential for another $1.8 billion — for worldwide rights to two of POINT Biopharma’s late-stage cancer therapeutic candidates. Read More
The potential for cleanroom contamination and other deficiencies led to a Form 483 for UFP Technologies, following an FDA inspection of the company’s Chicopee, Mass. facility. Read More