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Rapid antigen COVID-19 testing in adults doesn’t identify as many early infections as reverse-transcriptase polymerase chain-reaction (RT-PCR), but in children, accuracy was quite high, two new studies have found. Read More
The FDA expects companies to identify trends while analyzing their quality data — and to act on what they learn. In other words, the FDA expects companies to do more than provide the agency a look back at data and an after-the-fact reaction to quality problems. Companies must use trending techniques to catch — and address — quality problems early. Read More
Pennsylvania-based device and diagnostics consultancy RQM+ has acquired AcKnowledge Regulatory Strategies, a firm in San Diego, Calif., with an overlapping area of specialization. Read More
Anita Jackson, a physician in Raleigh, N.C., was indicted by a federal grand jury on Wednesday for allegedly adulterating medical devices for reuse on patients and other related charges. Read More
Medical device regulatory submissions with computational modeling evidence should include data proving the models’ credibility, the FDA advised in a new draft guidance. Read More
A Senate committee will vote whether to approve Robert Califf’s nomination to become FDA commissioner on Wednesday, Jan. 12 — a critical step before the full chamber can hold a confirmation vote on Biden’s pick to lead the nation’s medical device regulator. Read More
The Centers for Medicare and Medicaid (CMS) has expanded Medicare Part B coverage of continuous glucose monitors (CGMs) and some other kinds of durable medical equipment (DME). Read More