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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
The synthetic biologic product is used for interbody fusions of the thoracolumbar spine — the transitional zone between the thoracic cage and the mobile lumbar spine. 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with computational modeling evidence should include data proving the models’ credibility, the FDA advised in a new draft guidance.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
The glovemaker plans to add four production lines to the existing six at its Malaysian factory, which will boost production capacity to 2 billion pieces annually. Read More
Siemens Healthineers said it expects to make the test available in the U.S. this month and has “dedicated production capacity for U.S.-bound product in the tens of millions per month.” Read More