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The FDA has published a landmark final rule that creates a new category of over-the-counter (OTC) hearing aids aimed at improving access and lowering the cost of the devices. Read More
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
The test first received FDA approval in April 2021 for assessing the eligibility of patients with endometrial cancer for treatment with GSK’s Jemperli. Read More
Medtronic has released a software update to address the issue, but patients will need to do an in-clinic visit for the update to be installed. Read More