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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

Bioprinting Ear Tissue Tagged Rare Disease Treatment

3-D bioprinter

A company developing 3-D printed outer ear tissue received a rare pediatric disease designation on its treatment designed for children. . . . → Read More: Bioprinting Ear Tissue Tagged Rare Disease Treatment

Retail Clinics Offer A.I.-Enabled Eye Diagnostics

Fundus photograph

A chain of primary care clinics in grocery stores is adding diagnostics using artificial intelligence to detect an eye disorder resulting from type 2 diabetes. . . . → Read More: Retail Clinics Offer A.I.-Enabled Eye Diagnostics

Safety Reports Analyzed with A.I. to Reduce Medical Errors

Data and person graphic

Research is underway to write algorithms for analyzing free text and other unstructured data in safety report databases to reduce medical errors. . . . → Read More: Safety Reports Analyzed with A.I. to Reduce Medical Errors

Partnership to Assess Digital Gut Disease Treatments

Circuit board

A digital therapeutics enterprise and a company developing therapies for intestinal disorders are evaluating the potential of digital treatments for gut diseases. . . . → Read More: Partnership to Assess Digital Gut Disease Treatments

FDA – New Processes, Incentives Needed for Drug Shortages

Pills and dollar bill

A report from the Food and Drug Administration identifies the causes of recent shortages of some drugs, and calls for new processes and incentives to prevent future shortages. . . . → Read More: FDA – New Processes, Incentives Needed for Drug Shortages

FDA Tags Biofilm Disruption Device as Breakthrough

MRSA bacteria

A system using an electric current to break up bacterial communities on orthopedic implants received a breakthrough-device designation from the Food and Drug Administration. . . . → Read More: FDA Tags Biofilm Disruption Device as Breakthrough

Real-World Evidence Assessed for Cancer Drug Trials

Two medical technology companies are evaluating real-world evidence from patients to simulate randomized clinical trials for testing new cancer treatments. . . . → Read More: Real-World Evidence Assessed for Cancer Drug Trials

Peanut Allergy Patch Under FDA Review

Peanutes in shells

A device to build a tolerance of peanuts in children with a peanut allergy, worn like a patch on the skin, is under review by the Food and Drug Administration. . . . → Read More: Peanut Allergy Patch Under FDA Review