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Merit Medical Celebrates FDA Approval of WRAPSODY™
An update from Merit Medical Systems ( ($MMSI) ) is now available. On January 28, 2025, Merit Medical Systems held a conference call to discuss ...
FDA approves wearable infusion device for advanced Parkinson disease
The U.S. Food and Drug Administration has approved Onapgo (apomorphine hydrochloride) injection as the first and only ...
JD Supra3d
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 ...
Supernus Gets FDA Approval of Onapgo Device for Parkinson's Disease
Supernus Pharmaceuticals has won Food and Drug Administration approval for its Onapgo device to treat patients with Parkinson's disease.
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, ...
Acrivon Therapeutics Gets FDA Breakthrough Device Designation for Cancer Identification
Acrivon Therapeutics said the Food and Drug Administration has granted Breakthrough Device designation for its ACR-368 OncoSignature assay, an immunofluorescence assay for the identification of ...
U.S. FDA approves Supernus' drug-device combination for Parkinson's disease
The U.S. Food and Drug Administration has approved Supernus Pharmaceuticals' drug-device combination to treat ...
Medscape8d
Science Behind FDA-Approved Genetic Test for OUD Questioned
A new study suggests clinical utility of the first FDA-approved genetic test to help gauge an individual’s risk for opioid ...
Health Affairs6d
We Need More Robust Post-Market Surveillance For Health Care AI
The FDA’s framework for AI regulation, while robust for premarket evaluation, would benefit from more specific mechanisms for continuous monitoring of AI performance in diverse real-world settings.
Forbes6d
2025 Medical Device Cybersecurity Trends: What Will Shape The Industry?
Medical devices are ... year of the Food and Drug Administration’s (FDA) new guidance on security and privacy play out, putting pressure on manufacturers in both the premarket and postmarket.