Home / Tag Archives: Food and Drug Administration

Tag Archives: Food and Drug Administration

DARPA Unveils Scent-Based Technology for Mosquito Risk Reduction

The Defense Advanced Research Projects Agency is in need of research teams for the development of a scent-based technology to lower mosquito attraction through the temporary alteration of skin microbiome. The four-year ReVector project seeks to repel mosquitoes through the mediation of skin microbiome interaction and body metabolites to reduce the instances of disease transmission, DARPA said Friday.

Read More »

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 »

DHS Helping FDA Cyber Secure Medical Devices

The Department of Homeland Security is working with the U.S. Food and Drug Administration to protect connected medical devices from emerging cyber threats, Federal News Network reported Thursday. In October, DHS began using the medical device security playbook the FDA issued to guide the government and industry in protecting such technologies.

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FDA Issues Draft Guidance for Medical Device Cyber Management

The Food and Drug Administration has released a draft guidance to provide recommendations that seek to help companies address cyber risks in medical devices prior to the submission of premarket applications for their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 »

FDA Unveils Health Data Science Projects Under Incubator Program

Scott Gottlieb, commissioner of the Food and Drug Administration, has introduced information technology initiatives under the agency’s data science incubator program during  the Health Datapalooza conference in Washington, D.C., MedCityNews reported Thursday. Gottlieb highlighted the FDA’s Information Exchange and Data Transformation program that seeks to standardize methods to examine potential applications of artificial …

Read More »