Skip to main content

Bruker Registers Mass Specs with Korean Regulators as Medical Devices for IVD Apps

NEW YORK, Aug. 10 (GenomeWeb News) - Bruker Daltonics has registered its autoflex II MALDI-TOF mass spectrometers as class I medical devices with the Korean Food and Drug Administration, the company said today.

 

The registration helps Bruker's customers obtain regulatory approval for mass spectrometry-based in vitro diagnostic methods they developed, according to the company.

 

The mass spectrometers are already being used by GeneMatrix of Korea for molecular diagnostics applications, which the company offers to medical centers and university hospitals in Korea, according to Bruker. The autoflex II instruments are also part of Bruker's ClinProt system for peptide and protein biomarker profiling.

The Scan

Gap in COVAX Doses

BBC News reports that COVAX is experiencing a vaccine shortfall, as the Serum Institute of India has paused exports.

Sanofi, GSK Report Promising Results

The Wall Street Journal reports that the candidate SARS-CoV-2 vaccine from Sanofi and GlaxoSmithKline has had encouraging early results.

Influence of Luck

The New York Times examines how the US avoided variant-fueled increases in COVID-19 cases.

PLOS Papers on Retina GWAS, Hantaan Virus, COVID-19 Phenome-Wide Association Study

In PLOS this week: genome-wide association study of retinal morphology, analysis of hantaan virus found in a mouse, and more.