Reston, VA (Sept. 10, 2025) — The American College of Radiology® (ACR®) applauds inclusion of multiple ACR-backed provisions in the U.S.…
Browsing: Regulatory
WASHINGTON | Recently, the Cybersecurity and Infrastructure Security Agency (CISA) released a draft Minimum Elements for a Software Bill of Materials…
WASHINGTON, DC | AdvaMed, the MedTech Association, recently published a technical performance and safety whitepaper titled “Medical Imaging Device Cybersecurity:…
On July 30, 2025, the U.S. Food and Drug Administration (FDA) issued a Federal Register notice announcing medical device user…
Royal Philips has announced a major advancement in image-guided navigation for prostate cancer care with the FDA 510(k) clearance of the latest Philips UroNav version. The system includes a new advanced annotation workflow that supports clinicians during focal therapy procedures, helping deliver more precise, minimally invasive care.
Joint Commission this week launched Accreditation 360: The New Standard, a transformational approach to hospital and healthcare accreditation and certification,…
Experts from multiple medical societies have published a consensus document to provide guidance on how best to use cardiac CT…
WASHINGTON | On May 14, President and CEO Scott Whitaker of AdvaMed, the Medtech Association, testified before the U.S. Senate…
In a historic first for the agency, FDA Commissioner Martin A. Makary, M.D., M.P.H., today announced an aggressive timeline to…
Today, the U.S. Food and Drug Administration announced its intent to expand the use of unannounced inspections at foreign manufacturing…
