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510(k)

The FDA clearance follows earlier US marketing approval for the firm's C. Difficile assay.

The test detects 20 common viruses and bacteria that cause upper respiratory infections using the firm's high-throughput, automated MDx-3000 instrument.

Applied BioCode said that it now has access to higher volume laboratories that use the Roche MagNa Pure 96 System for sample extraction.

Akonni has received clearance for a molecular diagnostic instrument and a saliva-based pharmacogenomics test for warfarin metabolism.

The in vitro diagnostic is designed to detect whole gene segments for influenza A and B viruses and can characterize viruses as seasonal or nonseasonal.

The test completes a suite of assays designed to detect pathogens that can cause sepsis using the firm's ePlex system.

The firm had also applied for marketing clearance for its gram negative and fungal pathogen panels in October.

The enteric panel detects the viral cause of infectious diarrhea symptoms including norovirus, rotavirus, adenovirus, human astrovirus, and sapovirus.

The proposal establishes procedures and criteria for the de novo classification of medical devices that would clarify requirements for submission and review.

The US Food and Drug Administration is developing a new approach for clearing medical devices to take technological advances and modern safety and performance requirements into account.

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Russian CRISPR researcher moves along with plans to ultimately alter the genes of embryos of deaf couples, though awaits regulatory approval, Nature News reports.

University of California, San Francisco, researchers have uncovered a gene mutations that appears to make a father-son duo more efficient sleepers.

NPR reports a large health insurer has begun to cover some pharmacogenetic tests for psychiatric drugs.

In PLOS this week: genome-wide association study of non-syndromic orofacial cleft subtypes, epigenetic and transcriptomic analysis of pancreatic ductal adenocarcinoma, and more.