For the pharmaceutical industry caught in the crosshairs of a potential trade war, the consequences of U.S. tariffs on China or Europe remain largely speculative, although both would be detrimental, according to a Korea Biotechnology Industry Organization (KoreaBIO) issue briefing Feb. 7.
Newronika SpA's AlphaDBS recently secured an investigational device exemption from the U.S. FDA allowing it to begin a pivotal trial to evaluate the safety and efficacy of its adaptive deep brain stimulation system in patients with movement disorders, including Parkinson's disease.
The European Commission issued a set of guidelines for the use of AI as a supplement to the EU’s Artificial Intelligence Act, a document of which chatbot developers will want to take note.
The U.K.’s National Institute for Health and Care Excellence (NICE) historically relies on cost savings to vet novel medical technologies, but that may soon change per a Feb. 7 announcement.
Skin Analytics Ltd. received CE mark for its AI-based tool Deep Ensemble for the Recognition of Malignancy (DERM), which can assess images of lesions and detect skin cancer autonomously. The technology has an accuracy rate of 99.8% compared to 98.9% for dermatologists.
For the pharmaceutical industry caught in the crosshairs of a potential trade war, the consequences of U.S. tariffs on China or Europe remain largely speculative, although both would be detrimental, according to a Korea Biotechnology Industry Organization (KoreaBIO) issue briefing Feb. 7.
To say that European investors are optimistic about the outlook for the med-tech sector in 2025 is an understatement. A couple of companies are already listed on public markets, acquisitions have been undertaken and med-tech players with cash-rich balance sheets are on the hunt.
The U.K. Medicines and Health Care Products Regulatory Agency has provided guidance on what does and does not constitute a regulated digital mental health technology, but developers should be aware that promotional claims could push a product from the unregulated to the regulated category.
C the Signs Ltd. recently received a capital injection of $8 million from Khosla Ventures to expand its AI-powered cancer prediction platform to the U.S. market.
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