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How New Executive Orders May Affect FDA’s Medical Device Operations
Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...
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FDA notifies veterinarians of animal burn risk linked to human medical devices
Following a recall of grounding pads produced by Megadyne, a machinery industry company, the FDA is notifying veterinarians ...
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Supernus wins FDA approval for Parkinson’s pump on fourth try
Supernus Pharmaceuticals has won US approval for its wearable pump Onapgo (apomorphine hydrochloride) to treat symptoms of ...
Acrivon Therapeutics Announces FDA has Granted Breakthrough Device Designation for ACR-368 OncoSignature Assay for Endometrial Cancer
The ACR-368-tailored OncoSignature assay is being used to predict patients most likely to respond to ACR-368 in Acrivon’s ongoing, ...
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Supernus Taps Potential $300M US Opportunity With FDA Win for Parkinson’s Drug-Device Combo
The FDA on Tuesday signed off on Supernus Pharmaceuticals’ apomorphine hydrochloride injection—to be marketed under the brand ...
Onc.AI Awarded FDA Breakthrough Device Designation for Serial CT Response Score Deep Learning Model
Onc.AI, a digital health company developing AI-driven oncology clinical management solutions using Deep Learning imaging AI, today announced that the U.S. Food and Drug Administration (FDA) has ...
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Newronika wins FDA IDE for adaptive deep brain stim tech
Newronika announced today that it received FDA investigational device exemption (IDE) for its deep brain stimulation (DBS) system.