Discover what regulated markets are, how they work, and their advantages and disadvantages. Learn how government oversight ...
The FDA ImportShield Program centralizes import review, increasing processing speed by 66% and volume capacity by 33%, while ...
On Jan. 6, 2026, the U.S. Food and Drug Administration (FDA) updated the final guidance documents General Wellness: Policy for Low Risk Devices (the General Wellness Guidance) and Clinical Decision ...
In four months, the program, which aims to modernize how the FDA reviews imported products, increased processing speed by 66% ...
Industry consultant Michael Drues will discuss how medical device companies can better prepare for FDA inspections.
The U.S. FDA’s Jan. 14 webinar for the new Quality Management System Regulation included some fairly predictable content, but one member of the FDA staff mentioned that the agency now expects ...
Abstract: Massive inverter-based controlled load (ITCL) cluster has immense potential for frequency regulation. It is of great significance to tap its active frequency support potential. The key ...
BOSTON, MA, UNITED STATES, January 6, 2026 / EINPresswire.com / — UltraSight™, a leader in AI-guided cardiac imaging workflows, today announced FDA clearance to expand its Echo Stewardship Platform to ...
Expanded authorization enables AI-guided FoCUS across devices—supporting consistent diagnostic-quality imaging and cardiology oversight across care settings BOSTON ...
The EU MDCG 2025-10 Guidance on Post-Market Surveillance of Medical Devices and In Vitro Diagnostic Medical Devices (Dec 2025) provides manufacturers with detailed interpretations of MDR and IVDR PMS ...
MALVERN, PA / ACCESS Newswire / January 8, 2026 / Toetal Solution, Inc., a Runway Healthcare company, announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the ...
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