Upon validation, device developers will also have the opportunity to showcase their connected care technologies in the Oracle ...
Is your medical device company ready for the QMSR shift? Engineer Aldo Vidinha explains why "checkbox compliance" is over and how the FDA’s alignment with ISO 13485 redefines quality as a connected, ...
Following eyonis® LCS' FDA 510 (k) clearance announced on February 9, 2026, Median has activated a phased U.S. launch strategy designed for disciplined national expansion. The Company has conducted ...
Regulators are modernizing their expectations, and it's become clear that validation can no longer function as a point-in-time event.
The Stealth AXiS system architecture allows support for a variety of surgeon preferences and clinical complexities.
IEEE Spectrum on MSN
What the FDA’s 2026 update means for wearables
Simpler rules apply to less invasive hardware ...
The MarketWatch News Department was not involved in the creation of this content. eMurmur Heart AI is the intelligence layer that can power auscultation hardware and software, providing accurate heart ...
eMurmur Heart AI is the intelligence layer that can power auscultation hardware and software, providing accurate heart sound analysis in seconds OTTAWA, ON, Jan. 29, 2026 /PRNewswire/ -- eMurmur® is ...
The updated eMurmur software expands compatibility from just one digital stethoscope model to more and introduces a new feature. [Photo courtesy of eMurmur] eMurmur has received FDA 510(k) clearance ...
MINNEAPOLIS, Jan. 22, 2026 (GLOBE NEWSWIRE) -- OneMedNet Corporation (Nasdaq: ONMD), a leading provider of regulatory-grade, AI-ready Real-World Data (RWD), today announced that its high-quality, ...
NEW YORK – The US Food and Drug Administration granted and updated 510(k) clearances for about a dozen assays, as well as software for digital pathology-based analyses, to end 2025. Among rapid tests ...
In pharmaceutical manufacturing, software validation is innovation’s silent killer. A single user requirements specification (URS) takes weeks. Test plans stretch for months. Change controls bog down ...
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