Tuesday, June 25, 2019
A reimagined approach to premarket review for AI and machine learningdriven modifications to medical devices is underway at the federal agency. The FDA is crafting a new regulatory framework to promote the development of safe and effective medical devices powered by advanced artificial intelligence algorithms. The agency sees promise in adaptive AI and machine learning
[ Read More ]We strongly believe that only digital health can bring healthcare into the 21st century and make patients the point-of-care. Mental health algorithms mimicking empathy? A.I. outsmarting human doctors? Simple big data analytical software presented with clever marketing tactics? Its difficult to assess the actual state of play when it comes to artificial intelligence in healthcare.
[ Read More ]Theranica, an Israel-based biomedical technology company focused on developing advanced electroceuticals for migraine and other prevalent diseases, announced on May 28 that the U.S. Food and Drug Administration (FDA) granted a De Novo request for its smartphone-controlled electroceutical, Nerivio Migra, utilising Remote Electrical Neuromodulation for the acute treatment of migraine.
[ Read More ]The U.S. Food and Drug Administration warned diabetics against building their own artificial pancreas system to help control blood sugar levels after a patient using one suffered an accidental insulin overdose.A large community of diabetics has been using hacked-together, do-it-yourself systems to control their disease. The systems connect glucose monitors to insulin pumps using computer
[ Read More ]brThe U.S. Food and Drug Administration (FDA) recently released its draft guidance on managing cybersecurity in medical device premarket submissions. However, leading companies such as GE Healthcare and industry groups have voiced concerns over the tiered approach, saying this will result in confusion and potential discrepancies. They want the tiered system eliminated or amended. Industry
[ Read More ]Some of the associations submitting comments on FDA’s draft guidance suggested modifications to the agency’s call for a “cybersecurity bill of materials,” or CBOM, that medical device makers would need to submit to the FDA for premarket review. Some also critiqued FDA’s proposal to define two tiers of medical devices based on their cybersecurity risk
[ Read More ]At the Food and Drug Administration, the physician and venture investor promoted policies focused on innovating approaches to population health, opioids, chronic disease, AI and precision medicine. Despite the concerns of some that his close ties with the pharmaceutical industry offered the potential for “unprecedented financial entanglements with the industries he would regulate as FDA
[ Read More ]Released yesterday, the document outlines FDA’s preference toward single applications for combination products. The FDA released new draft guidance yesterday regarding premarket review for combination products those with a mix of components that span across the agencys drug, biologic and device product categories.The proposed premarket guidance, which may still be adjusted based on public feedback,
[ Read More ]A health monitoring watch being developed by Alphabet, Google’s parent company, has received 510(k) clearance from the U.S. Food and Drug Administration as a medical device. This means that the FDA has found the devices to be safe and effective, and that they can legally be sold in the US.
[ Read More ]Globalization reached healthcare big time: a French patient can easily ask a Belgian company to sequence the DNA of his tumor tissue, then convince a Swiss pharma company to sign them up for a relevant clinical trial on a Spanish island. Not only that but also the recent controversies around gene editing in babies in
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