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.
Oxford Nanopore Technologies plc secured a £70 million (US$85 million) investment from Biomérieux SA. The investment comes on the back of a partnership formed between the two companies earlier in the year. The funds will support the development of products in Oxford Nanopore’s portfolio to serve in vitro diagnostics (IVD) markets.
Researchers have for the first time used human neural stem cells to print 3D brain tissues that mimic the architecture of the brain’s outer layer, the cerebral cortex. This breakthrough technique, developed by a team from the U.K.’s University of Oxford, could one day be used to provide tailored repairs to the millions of people who suffer from severe brain injuries, for which there is no effective treatment.
Olink Holding AB likely has some euphoric investors following Thermo Fisher Scientific Inc.’s announcement of an agreement to acquire the proteomics company for $26 per share in cash. The price represents a premium of nearly 75% on its recent trading average and brings the deal’s value to a stunning $3.1 billion, with net cash of $143 million.
The recent greenlight from European regulators to Tasso Inc. to market its Tasso+ device in the EU brings another solution to the market for blood collection Tasso has developed the Tasso+, a single-use blood lancing device that collects a microliter capillary blood from the upper arm. Tasso claims that it is the first device of its kind to get both CE mark and U.S. FDA approval.
The European Commission (EC) has ordered Illumina Inc. to sell Grail Inc. after it closed the acquisition without approval from EU regulators. The EC said that if Illumina fails to comply with the order, the company faces fines of up to 5% of its daily aggregate revenue or up to 10% of its annual worldwide revenue.
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