A 60-day appeal window has passed for the Food and Drug Administration to appeal a federal court ruling that invalidated its final rule to regulate laboratory-developed tests as medical devices, effectively eliminating it. The rule, issued last year, would have phased out its general enforcement discretion approach for most lab-developed tests over four years. The […]
The U.S. Food and Drug Administration (FDA) has issued a warning that some people develop severe itching after halting long-term use of the common antihistamines cetirizine (Zyrtec) and levocetirizine (Xyzal). The FDA said in a statement that it will update safety information on the label of these allergy medicines, which are available in both prescription […]
ANI | Updated: Nov 13, 2024 16:11 IST PRNewswireNew York [US], November 13: Fourth Frontier, a medical technology company based out of New York and Bangalore, announced the 510(k) clearance of the Frontier X Plus from the U.S. FDA. The Frontier X Plus is an innovative single-lead, continuous ECG monitor that is worn around the […]
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