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 ...
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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 ...
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Journey Medical: FDA Approval For Emrosi Makes This An Exciting Stock
Journey Medical, a specialty pharmaceutical company, focuses on dermatology and has achieved cashflow breakeven with its current $55mm-$60mm revenue and sales infrastructure. The FDA-approved ...
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FDA Approves Feasibility Study with SeaStar Medical’s Selective Cytopheretic Device in Adults with Cardiorenal Syndrome
announces that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) application to evaluate the safety and initial efficacy of SeaStar Medical’s ...
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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 ...
JD Supra16d
FDA Issues New Recommendations on Use of AI for Medical Devices, Drugs, and Biologics
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on ...
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FDA’s evolving regulatory framework for AI use in drug & device clinical trials and research
given that researchers who use AI software as a medical device in a clinical trial, and fail to have their device exempted, cleared, or approved by FDA, may face serious enforcement ramifications.
Business Wire11d
Medimaps Breaks New Ground in Fracture Risk Assessment with FDA Clearance and MDR Certification for TBS Osteo Next Generation Software
TBS Osteo’s next generation expands fracture risk assessment capabilities to assist a broader range of patient profiles. Advanced connectivity and usability features to streamline operations ...
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Medimaps Breaks New Ground in Fracture Risk Assessment with FDA Clearance and MDR Certification for TBS Osteo Next Generation Software
medimaps group S.A., a global leader in AI-driven bone microarchitecture imaging solutions, proudly announces 510(k) clearance from FDA and ... the only approved medical device software for ...
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J&J Seeks FDA Nod for Non-Muscle Invasive Bladder Cancer Drug
Johnson & Johnson JNJ has initiated a rolling submission with the FDA seeking approval for TAR-200, its investigational drug-device combination ... aim to address unmet medical needs or provide ...
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Medimaps Breaks New Ground in Fracture Risk Assessment with FDA Clearance and MDR Certification for TBS Osteo Next Generation Software
GENEVA, January 27, 2025--(BUSINESS WIRE)--medimaps group S.A., a global leader in AI-driven bone microarchitecture imaging solutions, proudly announces 510(k) clearance from FDA and MDR ... remains ...