Home / Tag Archives: medical device

Tag Archives: medical device

Scott Gottlieb: FDA Eyes Regulatory Framework for AI-Based Medical Devices

Scott Gottlieb, commissioner of the Food and Drug Administration, announced the release of a discussion paper as the agency considers developing new regulatory framework to advance the development of artificial intelligence-based medical devices. “We are exploring a framework that would allow for modifications to algorithms to be made from real-world learning and adaptation, while still ensuring safety and effectiveness of the software as a medical device is maintained,” Gottlieb said in a statement published Tuesday

Read More »

FDA Issues Draft Guidance for Medical Device Cyber Management

The Food and Drug Administration has released a draft guidance to provide recommendations that seek to help companies address cyber risks in medical devices prior to the submission of premarket applications for their products. FDA said Thursday the recommendations in the guidance document aim to facilitate the review process for premarket submissions and reduce the risk of patient harm associated with devices with cyber vulnerabilities.

Read More »

ImmixGroup’s Lloyd McCoy: DoD’s FY 2017 Budget Request Seeks to Deploy Commercial EHR System by 2022

Lloyd McCoy Jr., a market intelligence manager at immixGroup, has said the Defense Department’s budget request for fiscal year 2017 contains health information technology initiatives that would prioritize the deployment of a commercial electronic health record system. McCoy wrote in a Fedscoop commentary published Tuesday that DoD proposed the commercial …

Read More »

FDA Opens Comment Period on Medical Device Cybersecurity Guide

The Food and Drug Administration has released draft guidance to help manufacturers protect medical devices against cyber threats throughout the product lifecycle. The guide outlines postmarket strategies for the medical device industry to monitor, identify and address cybersecurity risks that could affect the performance and safety of their technology offerings, the FDA …

Read More »

FDA’s Suzanne Schwartz: Medical Device Manufacturers Need to Protect Against Cybersecurity Risks

The U.S. Food and Drug Administration recommends that cybersecurity measures become an inherent part of medical device design and development in the recently released final guidance for device manufacturers on cybersecurity risk management. “There is no such thing as a threat-proof medical device,” Suzanne Schwartz, director of emergency preparedness/operations and medical countermeasures at …

Read More »