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Becton Dickinson will co-market Accelerate Diagnostics’ rapid tests for antibiotic resistance and susceptibility under an agreement the companies announced yesterday. Read More
The FDA issued Revolutionary Science a Form 483 for documentation issues involving design changes, nonconforming product and in-process testing observed during an inspection of its Shafer, Minn., facility in April. Read More
The UK’s National Institute for Health and Care Excellence (NICE) is inviting comments on its first draft recommendation for a diagnostic device — AliveCor’s KardiaMobile 6L heart monitor — under a new fast-track review program called the Early Value Assessment pilot project. Read More
Process validation, according to the FDA’s Quality System Regulation (QSR), means “establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.” In other words: If a devicemaker cannot verify, by inspection or test, that each product specification has been met, the process itself must be tested, to ensure that it yields consistent results. Read More
The FDA handed Elite-Medical a Form 483 for problems with control of nonconforming products and a supplier issue observed during an inspection of its Florence, Ala., facility in April. Read More
The UK’s Department of Health and Social Care is seeking information for an independent review of the potential ethnic bias of certain medical devices such as oximeters and infrared scanners. Read More
An FDA inspection of Med Pen Concepts’ facility in Woburn, Mass., found the company lacked documentation of corrective and preventive action (CAPA) procedures, device history records, risk assessments and audit reviews for its plasma pen devices. Read More
Researchers in Europe used Abbott’s i-STAT TBI (traumatic brain injury) test to show how two blood-based biomarkers can effectively predict the initial outcome of such injuries. Read More