The U.K. National Institute for Health and Care Excellence (NICE) has undertaken a public consultation for a series of proposed changes to its procedures for evaluating medical devices and other medical technologies that could speed up these reviews. This new process would require a less time-consuming approach to evaluating lower-risk technologies that would not only turn around such evaluations more rapidly but would also leave more resources available for higher-risk products that would also enjoy a timelier review, thus potentially accelerating adoption of all these products in the National Health System.
The imaging and advanced guidance for workflow optimization in interventional oncology consortium (IMAGIO) consortium of clinical partners in the EU, led by Royal Philips NV, has been awarded $26 million under the Innovative Health Initiative (IHI) to carry out research into less invasive cancer therapies.
Stephanix SAS and Incepto Medical SAS reported signing a strategic partnership at the annual congress of the French association for female medical imaging (SIFEM) in Bordeaux. The companies are joining forces by way of a distribution agreement to improve the medical imaging available in France.
The U.K. Medicine and Healthcare Products Regulatory Agency (MHRA) has moved to incorporate the Global Medical Device Nomenclature (GMDN) system into its device registration database, a development that will ease the task of providing postmarket surveillance for these products. However, the change may also take some of the noise out of the registration process in the U.K. market, thanks to the standardization of information the GMDN represents.
The EU’s In Vitro Diagnostic Regulation (IVDR) has not yet been fully implemented, but Australia’s Therapeutic Goods Authority (TGA) is wasting no time attempting to harmonize with the IVDR.
Radiotherapy fractionation has had a significant impact on the morbidity associated with the procedure across a number of cancer types, and the U.K. National Institute for Health and Care Excellence (NICE) says it may be time to fractionate further for some breast cancer patients.
Artificial intelligence (AI) faces a number of interesting hurdles in the EU, such as the still-developing Artificial Intelligence Act (AI Act), which seems destined to treat health care uses as high-risk propositions. Corinne Dive-Reclus, director of global lab insights at Roche Diagnostics, said there are possible solutions, such as overwriting the AI Act’s risk classifications with the risk category provided by existing regulations, but there is an open question as to whether a fix will be in place to prevent a potentially disastrous risk framework for AI in health care.
IA Medical SAS raised $1.5 million to accelerate the development of its Alix chatbot, designed to support and make life easier for caregivers of patients suffering from Alzheimer's disease. The Klesia GIE investment fund, which depends on Agirc-Arrco GIE, the administrator of the French private-sector pension scheme, and the French sovereign bank BPIFrance SA contributed 46.42% of the financing. More than half of this financing corresponds to an opening of IA Medical SAS's capital to individual partners, including doctors.
The French government is officially launching a major national program for digital health. This priority research program and equipment (PEPR) in digital health is being piloted by two major government research bodies, the National Institute for Health and Medical Research (INSERM) and the National Institute for Research in Digital Science and Technology (INRIA). It has a budget of $65 million over seven years
Negotiations over the text of the EU’s Artificial Intelligence Act (AI Act) are drawing to a close, but stakeholders are concerned about several key aspects of the legislation, such as how the term “artificial intelligence” is defined. However, Medtech Europe and other groups, including medical professional societies, are also concerned that the provisions for governance of data would seem to exclude real-world data as a source of evidence, an oversight they say will diminish the utility of AI software in health care.
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