South Korea’s Ministry of Food and Drug Safety (MFDS) will head an international team of regulatory experts from 19 drug agencies worldwide, including the U.S. FDA and China National Institute for Food and Drug Control (NIFDC), to draft an international standard for artificial intelligence (AI)-based software.
The U.S. FDA, Health Canada, and the U.K. Medicines and Healthcare Products Regulatory Agency have once again sidestepped the usual mechanisms for international regulatory cooperation to strike a blow for harmonization.
Artificial intelligence (AI) is in full development, and advances are already used in many fields, including medicine. In oncology, these tools can identify a tumor in an image with 99% accuracy. But they can also miss it if the algorithm was not developed with the right data or the correct decisions. The 2023 European Society for Medical Oncology (ESMO) Congress brought together in Madrid doctors and deep learning experts to discuss the challenges and advances of AI in this area. And what’s better than asking an AI what its trainer has told it about AI?
The FDA town hall on the final day of the 2023 edition of the Med Tech Conference included the usual patter about the achievements at the agency’s Center for Devices and Radiological Health (CDRH), but a few useful nuggets of information nonetheless slipped through in this year’s session. CDRH director Jeff Shuren acknowledged that the agency is steering device advisory committee hearings away from votes on whether to approve a product, an approach he said is under consideration at the agency’s other product centers as well.
Responding to the burgeoning field of digital health, the U.S. FDA reported the creation of a new Digital Health Advisory Committee that it expects to be up and running in 2024.
Unlocking the future of drug development often means removing obstacles that currently stand in the way. Reimbursement is one of those obstacles, as is keeping humans deeply involved as innovators and patients even as artificial intelligence (AI) increases its role. A panel of developers spoke about what they anticipate will be the biggest changes in the coming 10 to 20 years at the BioFuture 2023 conference in New York on Oct. 5. A common theme was reforming the structure of reimbursements, which has traditionally been a problem in the digital therapeutic realm, according to Eric Elenko, chief innovation and strategy officer at Puretech Health plc.
Unlocking the future of drug development often means removing obstacles that currently stand in the way. Reimbursement is one of those obstacles, as is keeping humans deeply involved as innovators and patients even as artificial intelligence (AI) increases its role. A panel of developers spoke about what they anticipate will be the biggest changes in the coming 10 to 20 years at the BioFuture 2023 conference in New York on Oct. 5. A common theme was reforming the structure of reimbursements, which has traditionally been a problem in the digital therapeutic realm, according to Eric Elenko, chief innovation and strategy officer at Puretech Health plc.
The U.S. FDA may be the most prominent agency in the federal government when it comes to the use of real-world data (RWD), but the National Institutes of Health is keen to immerse itself in this trove of information. The agency has made a request for public comment on how NIH centers can best leverage RWD for biomedical and behavioral research, although some ethical and practical considerations may have to be overcome.
Israeli startup Briya Ltd. raised $11.5 million in series A financing which will support the expansion of its health care data exchange platform across Europe and the U.S. The round was led by Team8, and included existing investors Insight Partners, and Amiti Ventures, and was joined by the George Kaiser Family Foundation.
Proteome analysis with artificial intelligence has made it possible to create a catalog of all possible missense mutations in the human genome to predict diseases.
