Category: Regulations
-
A.I. Heart Ultrasound Software Cleared by FDA
Software guided by algorithms that capture top-quality ultrasound images of the heart is now authorized by the Food and Drug Administration.
-
FDA Approves Children’s Peanut Allergy Drug
The U.S. Food and Drug Administration on Friday approved the first treatment for children to reduce severe allergic reactions to peanuts.
-
FDA Clears A.I. Algorithms for Stethoscopes
Algorithms used in analytical software for digital stethoscopes to diagnose irregular heart rhythms received marketing clearance from the U.S. Food and Drug Administration.
-
Virtual Assistants Offer Little Medical Emergency Help
An evaluation of four virtual digital assistants shows these services return widely varying levels of help with questions about first aid and medical emergencies.
-
FDA Issues Draft, Final Gene Therapy Guidance
The U.S. Food and Drug Administration today issued new draft guidance for reviewing gene therapies as orphan drugs for rare diseases.
-
FDA Clears Placenta Cell Brain Cancer Trial
A company developing cancer therapies with stem cells from human placentas says FDA cleared its request to start a clinical trial of a treatment for brain cancer.
-
Infographic – Mediocre ClinicalTrials.gov Report Rates
New data show most sponsors of clinical trials are not reporting their results on time to a U.S. government web site as required by law.
-
Infographic – U.S. Measles Cases Spike in 2019
CDC says the 1,282 cases is the largest annual number since 1992.
-
Food Banks Shown to Improve Nutrition, Food Security
Surveys of individuals in a food bank’s diabetes prevention program show the program in six months improves diet quality, overall health, and food security of participants.
-
Juul Delivers More Nicotine than Cigarettes, Other E-Cigs
Tests of aerosol compounds inhaled by lab animals show Juul devices send more nicotine into the blood stream than other e-cigarettes and ordinary cigarettes as well.