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.