Sunday, June 24, 2018
The Food and Drug Administration should consider some sort of measuring stick when assessing a vendor’s cybersecurity culture to determine if it qualifies for the agency’s proposed fast-path program for premarket approval of “software as a medical device” products, some industry stakeholders say.
[ Read More ]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
[ Read More ]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
[ Read More ]The Food and Drug Administration plans to launch a full-scale version of its digital health precertification program by the end of the year. Dubbed Pre Cert 1.0, the program will be the first formal iteration of a pilot project launched with nine companies last September.
[ Read More ]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
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