The Food and Drug Administration (FDA) is classifying the wearable vibration device for orthopedic use into class II (special controls) effective November 5, 2026. According to the FDA, this classification will provide…
The Food and Drug Administration (FDA) is classifying the prognostic assessment software of mild cognitive impairment into class II (special controls) as of November 5, 2026. According to the FDA, this classification…
On November 5, 2026, the Food and Drug Administration (FDA) announced the classification of the digital cervical cytology slide imaging system with artificial intelligence algorithm into class II (special controls)…
On November 2, 2026, the Food and Drug Administration (FDA) issued an Early Alert regarding a potential high-risk issue with ButterflyBVM Single-Use Bag-Valve-Mask Resuscitators. According to the FDA, Compact Medical…
On September 24, 2026, Philips Ultrasound, LLC initiated a Class I recall for its Lumify Diagnostic Ultrasound System. The recall affects devices distributed worldwide, including across the United States and numerous…
On September 17, 2026, Ventec Life Systems, Inc. initiated a Class I recall of several ventilatory support devices due to a potential safety issue. The recall affects devices including the VOCSN and V+ Pro Emergency…
On November 1, 2026, the Food and Drug Administration issued an Early Alert regarding a recall of the Streamline Bloodline Set for Dialog+ by B. Braun Medical Inc. The company recommended that affected customers remove…
The U.S. Food and Drug Administration issued final guidance on November 2, 2026, for manufacturers of cellular and gene therapy products to ensure their products meet potency standards. The guidance provides…
On October 29, 2026, the Food and Drug Administration announced a recall involving the StatStrip Glucose Hospital Meter System due to potential risks of assigning glucose results to the wrong patient. Nova Biomedical…
The Food and Drug Administration (FDA) is classifying the software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer into class II (special controls) effective October 30…
On October 30, 2026, the Food and Drug Administration (FDA) announced the classification of radiology software for referral of findings related to fibrotic lung disease into class II (special controls). This…
On October 30, 2026, the Food and Drug Administration (FDA) issued a final order classifying the spinal imaging system for neuraxial procedures into class II (special controls). The FDA determined that this…
The Food and Drug Administration (FDA) is classifying the over-the-counter device to assess risk of sleep apnea into class II (special controls) effective October 30, 2026. According to the FDA, this classification…
On October 21, 2026, the Food and Drug Administration announced a Class I recall of medical devices from Instrumentation Laboratory. The recall, which began on September 3, 2026, affects the HemoslL AcuStar…
On October 28, 2026, the Food and Drug Administration (FDA) announced that Medline has issued an Urgent Medical Device Field Safety Notice regarding the discontinuation and market exit of all Medline Brand beds and…
The U.S. Food and Drug Administration announced the launch of the Neuroscience Advancement and Innovation Nexus (NAIN) on October 22, 2026. This new program aims to advance the science, tools, and regulatory approaches…
On October 20, 2026, B. Braun notified customers of a recall for the Streamline Bloodline Set for Dialog+, citing a potentially high-risk device issue. The Food and Drug Administration (FDA) issued an Early Alert on…
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