FDA

FDA Unveils Plan for ‘Software as a Medical Device’ Review

The proposed voluntary program is for review of “software-as-a-medical-device” products, or SaMD – software that is “intended to treat, diagnose, cure, mitigate or prevent disease or other conditions.” Today, such software faces the same regulatory review as medical device hardware.Examples of SaMD range from software that allows a smartphone to view images obtained from a

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FDA chief sees big things for AI in healthcare

Scott Gottlieb, MD, is bullish on the opportunities artificial intelligence could bring to EHRs, decision support and more.At AcademyHealths 2018 Health Datapalooza on Thursday, the U.S. Food and Drug Administration offered a vote of confidence for artificial intelligence in healthcare, promising more refined strategies for regulation, touting its tech incubator for AI innovation and announcing

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FDA takes a longand long-termlook at device safety in new plan

The Food and Drug Administration appears to be taking a proactive and long-term approach toward improving medical-device safety. On April 17, the FDA released its Medical Device Safety Action Plan, in which regulators set out their goals for improving device safety, including tracking a product’s safety throughout its life-cycle and catalyzing innovation that will make

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FDA permits marketing of AI-based device to detect certain diabetes-related eye problems

The U.S. Food and Drug Administration today permitted marketing of the first medical device to use artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes.Diabetic retinopathy occurs when high levels of blood sugar lead to damage in the blood vessels of the retina, the

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FDA grants first approval to autonomous AI-powered medical device

For the first time, the Food and Drug Administration has approved marketing a medical device that uses artificial intelligence that doesn’t require a clinician to interpret the input.On Wednesday, IDx, an Iowa-based company, received approval to market its retinopathy-detecting software, IDx-DR. This is the first screening device the FDA has authorized that doesn’t need a

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