Saturday, April 21, 2018
The agency released a five-point plan outlining regulatory changes to bolster medical device safety, including requiring manufacturers ensure devices can be updated and patched.
[ Read More ]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
[ Read More ]The Food and Drug Administration has issued plans – some of which will require Congressional approval – for enhancing the safety of medical devices. Those include several proposals for advancing cybersecurity, including imposing new requirements on device manufacturers.
[ Read More ]The FDA is requesting Congressional funding and authority to create a medical device cybersecurity response team, a public-private partnership that can respond to incidents and investigate attacks. The team would be part of a $70 million request to advance digital health technology.
[ Read More ]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
[ Read More ]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
[ Read More ]U.S. health regulators said on Wednesday it will allow sale of the first medical device that uses artificial intelligence (AI) software to detect greater than a mild level of the most common cause of vision loss among more than 30 million Americans living with diabetes.
[ Read More ]The FDA has launched a free mobile app version of its [email protected] online database that offers consumers information on agency-approved drugs. The new app, called [email protected] Express, is free and currently available for download on iOS and Android.
[ Read More ]A new AI application that can analyse imaging data and alert physicians of a potential stroke in patients has received approval from the U.S. Food and Drug Administration (FDA). The Viz.AI Contact app uses an AI algorithm to analyse computed tomography (CT) scans and identify signs of a stroke in patients. When the app identifies
[ Read More ]The FDA plans to use approximately $400 million to create a Center of Excellence on Digital Health, which would house the agency’s new precertification program, and develop analytic and natural language processing tools to integrate real-world data from at least 10 million EHRs. …read more
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