FDA

FDA Debates Framework for AI-Based Medical Devices

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

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FDA Approvals For Smart Algorithms In Medicine In One Giant Infographic

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.

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FDA grants De Novo clearance to smartphone-controlled acute migraine-relief device

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.

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Patient Hurt by Do-It-Yourself Artificial Pancreas Prompts FDA Warning

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

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Tiered FDA medical device security guidance concerns industry

brThe U.S. Food and Drug Administration (FDA) recently released its draft guidance on managing cybersecurity in medical device premarket submissions.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

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FDA Commissioner Scott Gottlieb to step down

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

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FDA’s new draft guidance could hinder applications for digital combination products

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,

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Healthcare And Medicine Needs A Global FDA

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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