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Skin Cancer Apps Shown Misleading, Unreliable

Phone photo

A review of smartphone apps that photograph and purport to analyze skin conditions for signs of cancer shows the apps are unreliable in detecting cancer. . . . → Read More: Skin Cancer Apps Shown Misleading, Unreliable

A.I. Heart Ultrasound Software Cleared by FDA

Caption Guidance screen

Software guided by algorithms that capture top-quality ultrasound images of the heart is now authorized by the Food and Drug Administration. . . . → Read More: A.I. Heart Ultrasound Software Cleared by FDA

Skin Patch Senses Glucose, Emits Insulin as Needed

Insulin patch

A bio-engineering team developed a small patch worn on the skin that in lab mice and pigs senses blood glucose levels and releases insulin when required. . . . → Read More: Skin Patch Senses Glucose, Emits Insulin as Needed

FDA Approves Children’s Peanut Allergy Drug

Palforzia capsules

The U.S. Food and Drug Administration on Friday approved the first treatment for children to reduce severe allergic reactions to peanuts. . . . → Read More: FDA Approves Children’s Peanut Allergy Drug

FDA Clears A.I. Algorithms for Stethoscopes

Heart check

Algorithms used in analytical software for digital stethoscopes to diagnose irregular heart rhythms received marketing clearance from the U.S. Food and Drug Administration. . . . → Read More: FDA Clears A.I. Algorithms for Stethoscopes

FDA Issues Draft, Final Gene Therapy Guidance

Adeno-associated virus

The U.S. Food and Drug Administration today issued new draft guidance for reviewing gene therapies as orphan drugs for rare diseases. . . . → Read More: FDA Issues Draft, Final Gene Therapy Guidance

FDA Clears Placenta Cell Brain Cancer Trial

Pregnant woman

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. . . . → Read More: FDA Clears Placenta Cell Brain Cancer Trial

Infographic – Mediocre ClinicalTrials.gov Report Rates

Chart: Clinical trials report

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. . . . → Read More: Infographic – Mediocre ClinicalTrials.gov Report Rates

Artificial Pancreas System Cleared by FDA

Artificial pancreas system

A system for automatically measuring blood glucose levels and dispensing insulin for people with type 1 diabetes is authorized by the Food and Drug Administration. . . . → Read More: Artificial Pancreas System Cleared by FDA

FDA Blocks Monthly HIV Drug Combo

T-cell infected by HIV

The U.S. Food and Drug Administration rejected a combination of experimental and existing drugs given once a month to treat HIV. . . . → Read More: FDA Blocks Monthly HIV Drug Combo