Becker's Hospital Review15h
1 in 3 FDA safety reports filed late or with missing, invalid dates
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 ...
JD Supra1d
FDA Debuts a New Communications and Compliance Tool for Device Data Integrity Concerns
Yesterday, the U.S. Food and Drug Administration (FDA) updated its website to provide new information on data integrity concerns relating to ...
MedTech Dive1d
J&J’s Monarch robot wins FDA nod for AI software update
Using Nvidia and GE Healthcare technology, the robotic surgery system is intended to help doctors detect lung cancer earlier.
Daxor Corporation CEO and President Michael Feldschuh Provides Corporate Update in Letter to Shareholders
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 ...
STAT16d
There’s a better way to get drugs on the market: progressive approval
Perakslis is a medical and privacy researcher and has served in the FDA. Stebbins is a health and science consultant and served in the White House. The public and pharmaceutical companies are ...
BioSpace16d
Avance Biosciences™ Registers with CLIA, Expanding Clinical Trial Testing Capabilities
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 ...
Yahoo Finance16d
Visby Medical™ Receives FDA Clearance and CLIA Waiver for Point-of-Care Respiratory Health Test
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 ...
BioSpace17d
Visby Medical™ Receives FDA Clearance and CLIA Waiver for Point-of-Care Respiratory Health Test
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 ...
KELOLAND News17d
CytoChip Receives FDA Clearance and First CLIA Waiver for a Cartridge-Based Complete Blood Count Test
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 ...
Mena FN17d
Cytochip Receives FDA Clearance And First CLIA Waiver For A Cartridge-Based Complete Blood Count Test
(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 ...
Medscape22d
Evaluation of Drug Information Databases for Personal Digital Assistants
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 ...