The FDA has officially rescinded the rule expanding its authority over laboratory-developed tests following a federal court decision, reverting oversight to prior regulations. Meanwhile, novel clearances include Medtronic’s FDA approval for its minimally invasive tibial neuromodulation device targeting urinary incontinence and Organox’s machine perfusion device approved for preserving donor organs during air transport. These regulatory shifts and device approvals signal evolving landscapes in diagnostics and medical device utilization.