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Verax Biomedical Submits 510 Application to FDA for Platelet PGD Test
Verax Biomedical, developer of rapid tests for detecting bacterial contaminants in blood cells and tissue, has submitted a 510 (k) application to the ...

xCoupler Module Provides Guaranteed Data Delivery Between Plant Floor Devices and Business Systems
For accurate, timely and assured data delivery between plant floor devices and business systems, xCoupler plant to business system data modules from O...

FDA Issues Final Guidance For Safe Production
The Food and Drug Administration (FDA) has published a draft final guidance advising processors of fresh-cut produce how to minimize microbial food sa...

FDA Strengthens Safety Information for Erythropoiesis-Stimulating Agents
The U.S. Food and Drug Administration (FDA) has issued a public health advisory outlining new safety information, including revised product labeling a...

FDA Update on Peanut Butter Recall
As a follow-up to the recent Salmonella outbreak linked to peanut butter, the U.S. Food and Drug Administration (FDA) is informing consumers that ConA...

Human Growth Hormone from Cangene gets FDA Approval
Cangene said that it has received an approvable letter from the United States Food and Drug Administration ("FDA") for Accretropin, Cangene's recombi...

340B Prime Vendor Program Adds OTC Diagnostic Test Kits to Its Pharmacy Portfolio for the Safety-Net
The 340B Prime Vendor Program, managed by HealthCare Purchasing Partners International® ("HPPI"), announced that it has added FDA-approved OTC diagnos...

CytoCore Launches Clinical Trials for the e2 Collector
CytoCore, said that it has begun three “marketing confirmation” trials for the e2 Collector™ cervical cell collection device. These trials will compar...

Datascope's Safeguard Gets FDA Approval
Datascope said that it has FDA 510(k) clearance to claim that its Safeguard manual compression assist device reduces active (manual) compression time ...

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