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THINQ provides quantitative reports that include images of the brain with color-coded segmentations, in addition to plots that show how its measurements compare with reference data. Read More
The rapid four-in-one diagnostic is used on the GeneXpert System, and its largest model can run up to 80 tests at a time and process approximately 2,000 tests daily, Cepheid said. Read More
The new regulation goes into effect on May 26, 2022, except for in vitro diagnostics that qualify for a grace implementation period that extends to May 27, 2024. Read More
ISU’s vaccine is “intended to address some of the limitations of the vaccines currently in development by targeting room temperature storage and single-dose nasal self-administration as key capabilities,” Zeteo said. Read More
“Of serious concern is the fact that around 18 months away from IVDR date of application, the specific Class D conformity assessment infrastructure is limited or missing altogether,” MedTech Europe said. Read More
The solution provides several algorithms for heart conditions that can be run remotely, including normal and atrial fibrillation algorithms with improved sensitivity and specificity. Read More
The adjustable mesh device can be sequentially expanded, allowing its applied force to be gradually increased while the blood vessel is monitored. Read More
Claria provides on-screen dialysis instructions in 38 languages, as well as a web-based app that gives step-by-step, voice-activated instructions to direct therapy. Read More
The FDA issued an Emergency Use Authorization (EUA) for Lucira Health’s rapid coronavirus test, the first one authorized for self-testing at home and priced at an affordable $50. Read More
When undergoing an FDA inspection of a manufacturing plant, complying with agency requests and professional interactions with the investigators are the key, a panel of former FDA investigators advised during the 15th Annual FDA Inspection Summit hosted by FDAnews. Read More