The U.K. National Institute for Health and Care Excellence (NICE) has seen the nation’s spending numbers for diabetes, which is said to account for roughly 10% of healthcare spending in the U.K., and responded in a collaboration with the National Health Service (NHS).
Companies developing Artificial intelligence (AI)-enabled solutions have agreed to work with governments to test models both pre- and post-deployment, in a bid to manage the risks around security, safety and societal harms. The landmark agreement was reached at the first AI Safety Summit, held at Bletchley Park, in the U.K.
Sibionics Technology Co. Ltd. said it received the CE mark for its continuous glucose monitoring (CGM) system, coined the Sibionics GS1 CGM, helping the company expand its market opportunities beyond China.
The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has converted its regulatory sandbox for artificial intelligence (AI) into a full-fledged program dubbed the AI-Airlock, described as a regulatory-monitored virtual area in which industry can “generate robust evidence for their advanced technologies.” MHRA said it is focused on ensuring that AI products are available in the U.K. “before they are available anywhere else in the world,” a sign that national economic competitiveness is fostering a regulatory willingness to deal with uncertainty about this class of products.
Immuone Ltd. raised £2 million (US$2.4 million) to fund expansion of its operations to meet growing demand for its 3D human lung model. The company is hoping that its model will replace animal testing which is not always accurate at predicting the impact of drugs on humans. The funding came from the MEIF Proof of Concept & Early Stage Fund, Mercia’s EIS funds and Pioneer Group.
Conncons GmbH filed for patent protection of its networked medical infusion systems. The connecting components of their infusion systems house sensors that can detect data associated with medications in drug reservoirs.
The U.K. government has launched a £100 million (US$122 million) fund that will accelerate the development of artificial intelligence (AI) tools to help tackle some of the biggest challenges in health care.
Virtually all regulatory systems present at least some ambiguity as to the respective regulatory status of software when installed in hardware for medical purposes, and the European Commission’s (EC’s) Medical Device Coordination Group (MDCG) has attempted to provide clarity on these questions.
The U.K. National Institute for Health and Care Excellence (NICE) is offering provisional coverage for digital health technologies for specialist weight-management services as part of its early value assessment (EVA) series.
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.