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- FDA issues early alert on Philips Lumify ultrasound system software and connection problemsThe FDA’s Center for Devices and Radiological Health has released an Early Alert about a potential high‑risk issue with Philips Lumify diagnostic ultrasound devices. The problem involves either a s…
- FDA unveils transparency roadmap with plans for public NDA/BLA disclosures and inspection report publishingThe FDA published a transparency roadmap that outlines its FY 2026 achievements and sets out priorities for FY 2027. One key priority is a proposal to require public disclosure of new drug applica…