of AI known as machinelearning (ML), has become an important part of an increasing number of medicaldevices." The FDA noted that one of the greatest potential benefits of AI/ML is in its ability to create new and important insights from the vast amount of data generatedduring the delivery...
Interpretation must be made by a qualified pathologist, within the context of a patient's clinical history, proper controls, and other diagnostic tests. Herceptin BLA 103792 INFORM HER-2/NEU P940004S001 Ventana Medical Systems, Inc. (trastuzumab) The Inform Her-2/Neu gene detection system is a...
The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has posted the lists of medical device guidance documents it will prioritize for fiscal year 2017, pursuant to the Medical Device User Fee Amendments of 2012 (MDUFA III) (Public Law 112-114). CDRH...
Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the United States (U.S.), including those that are imported for export only, are required to register annually with the FDA. Most establishments that are required to ...
The FDA’s webpage, Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices, provides a list of devices that have been authorized via 510(k) clearance, De Novo requests, or premarket approval (PMA). Inc...
FDA’s list of AI-enabled device authorizations includes more than 850 devices; 72 are from GE HealthCare –more than any other medical technology company CHICAGO--(BUSINESS WIRE)-- GE HealthCare has topped a U.S. Food and Drug Administration (FDA) list of artificial inte...
Open Data NHS Scotland Medical reference data and statistics by Public Health Scotland No Yes Unknown Open Disease API for Current cases and more stuff about COVID-19 and Influenza No Yes Yes openFDA Public FDA data about drugs, devices and foods apiKey Yes Unknown Orion Health Medical platform...
The Food and Drug Administration (FDA) is publishing a list of documents issued in response to the Food and Drug Administration Modernization Act of 1997 (FDAMA), and clarifying their applicability to medical devices regulated by the Center for Biologics Evaluation and Research (CBER). This notice...
FDA. (2022, August 4). Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma. Retrieved from https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma Superior Court of New Jersey Law Division. (...
Open Data NHS Scotland Medical reference data and statistics by Public Health Scotland No Yes Unknown Open Disease API for Current cases and more stuff about COVID-19 and Influenza No Yes Yes openFDA Public FDA data about drugs, devices and foods apiKey Yes Unknown Orion Health Medical platform...