Medical Innovation Exchange

cardiovascular

USPTO Issues Patent for Risk Detection of Cardiovascular Disease   

USPTO Issues Patent for Risk Detection of Cardiovascular Disease        The U.S. Patent and Trademark Office (USPTO) has issued a notice of allowance to University of Iowa Research Foundation (UIRF) for U.S. Application No. 17,857,723 titled “Compositions and Methods for Detecting Predisposition to Cardiovascular Disease,” which is exclusively licensed to the Cardio Diagnostics Holdings …

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FDA Announces Cardiac Health and AI Model Predictions (V-CHAMPS) Challenge Winners

FDA Announces Cardiac Health and AI Model Predictions (V-CHAMPS) Challenge Winners     The FDA has announced the five winners of the Veterans Cardiac Health and AI Model Predictions (V-CHAMPS) Challenge. They are: VHeartAI ZS Associates ADS DSS Cognizant Good HeartML D&D The V-CHAMPS challenge was developed by the Veterans Health Administration (VHA) Innovation Ecosystem (IE), …

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FDA Announces Expansion of Total Product Life Cycle Advisory Program Pilot

FDA Announces Expansion of Total Product Life Cycle Advisory Program Pilot     Beginning October 1, 2023, the FDA’s Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot will expand to include the Office of Neurological and Physical Medicine Devices (OHT5). The FDA’s Center for Devices and Radiological Health (CDRH) developed the voluntary Total Product Life …

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FDA Announces Expansion of Total Product Life Cycle Advisory Program Pilot

FDA Announces Expansion of Total Product Life Cycle Advisory Program Pilot     Beginning October 1, 2023, the FDA’s Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot will expand to include Neurological and Physical Medicine Devices. The FDA’s Center for Devices and Radiological Health (CDRH) developed the voluntary Total Product Life Cycle (TPLC) Advisory Program …

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Advancing Digital Health: Huma SaMD Platform Gains U.S. Clearance

Advancing Digital Health: Huma SaMD Platform Gains U.S. Clearance     This week Huma Therapeutics received 510(k) clearance for its configurable Software as a Medical Device (SaMD) disease management platform, which previously received Class IIb approval in the EU. The FDA Class II clearance allows users to add AI algorithms to the disease-agnostic platform, potentially speeding …

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Johnson & Johnson to Expand Cardiovascular Segment with Abiomed Acquisition

Johnson & Johnson to Expand Cardiovascular Segment with Abiomed Acquisition     Johnson & Johnson has entered into a definitive agreement to acquire Abiomed, developer of breakthrough heart, lung and kidney support technologies, for approximately $16.6 billion. The transaction—expected to be completed prior to the end of the first quarter of 2023—will broaden Johnson & Johnson …

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