The United States Food and Drug Administration (FDA) is introducing the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH), it was reported on Tuesday.
The US FDA is to continue to build and formalise the coordinating structure and operation of the Digital Health Center of Excellence under its effort to modernise digital health policies and regulatory approaches.
The FDA is naming Bakul Patel as the first director. He has been leading regulatory and scientific efforts related to digital health devices at the US FDA since 2010.
Precigen announces FDA platform technology designation for AdenoVerse
Enhertu recommended for EU approval in early HER2-positive breast cancer
PureTech receives FDA Fast Track designation for LYT-200 in HR-MDS
MaaT Pharma outlines potential Phase 3 development plan for MaaT013 after CHMP negative opinion
Bayer's Kerendia wins FDA approval for chronic kidney disease associated with type 1 diabetes
Myosin Therapeutics chosen for 2026-2027 NCI Investor Initiatives Showcase
Medtronic receives FDA clearance for LigaSure RAS Maryland instrument on Hugo system
VaxThera partners with Codagenix for next generation yellow fever vaccine advancement
FDA approves Scholar Rock's ISEMBYLD to treat spinal muscular atrophy
FDA grants priority review to Takeda's zasocitinib application for plaque psoriasis
Armata Pharmaceuticals announces receipt of FDA Breakthrough Therapy Designation for AP-SA02
GSK reports positive Jideytro data supporting potential first-line lung cancer use