A new study analyzing the FDA's Manufacturer and User Facility Device Experience database found that nearly one-third of medical device safety reports were not submitted within the 30-day timeframe or ...

Yesterday, the U.S. Food and Drug Administration (FDA) updated its website to provide new information on data integrity concerns relating to ...

Oak Ridge, TN, March 04, 2025 (GLOBE NEWSWIRE) -- Daxor Corporation (Nasdaq: DXR), the global leader in blood volume measurement technology today issued a corporate update in a Letter to Shareholders ...

With its CLIA registration, Avance Biosciences is positioned to support clients in the development of small molecule drugs and biologics, including mRNA therapeutics and vaccines, monoclonal ...

The Visby Medical platform offers true PCR technology; PCR is the gold standard for testing Flu A, Flu B, and COVID-19. The Visby Medical Respiratory Health Test, which fits in the palm of your ...

SAN JOSE, Calif., Feb. 26, 2025 /PRNewswire/ -- Visby Medical ™ announced today that it has received 510(k) clearance and was granted a CLIA waiver from the U.S. Food and Drug Administration (FDA) for ...

The FDA clearance with CLIA Waiver (510(k) number K240402 and CLIA Waiver CW240006) validates its accuracy and reliability, ensuring that even non-laboratory personnel can operate the system ...

(MENAFN- EIN Presswire) The CLIA-waived CitoCBC® expands patient access to quick CBC results in physician offices, pharmacies, and home care, enabling data-driven diagnostics. IRVINE, CA, UNITED ...

Ten drug information databases were evaluated for scope, completeness, and ease of use: A2Z Drugs, AHFS Drug Information 2003, Clinical Pharmacology OnHand, DrDrugs, ePocrates Rx Pro, Lexi-Drugs ...

The Trump administration went to court Wednesday to defend a Biden-era FDA rule to oversee laboratory developed tests, despite earlier opposition to using that authority. The Food and Drug ...