Company Product Description Indication Status
Agilent Technologies Inc., of Santa Clara, Calif. Genetisure Dx Postnatal assay Qualitative assay to be used on the Surescan Dx Microarray Scanner system and analyzed by Cytodx software For the postnatal diagnosis of copy-number alterations and copy-neutral loss of heterozygosity from genomic DNA, obtained from the peripheral whole blood in patients who have been referred for chromosomal testing based on clinical presentation Received clearance from the Ministry of Health, Labour and Welfare in Japan
Carmat SA, of Vélizy-Villacoublay, France Total artificial heart Bioprosthetic artificial heart system For use as a bridge to transplant in patients with end-stage biventricular heart failure Received the CE mark
Interscope Inc., of Whitinsville, Mass. Endorotor system Includes a power console, foot control, specimen trap and single-use catheter; used to perform direct endoscopic necrosectomy For resecting and removing necrotic tissue for patients with walled-off pancreatic necrosis Received marketing authorization from the U.S. FDA via the de novo pathway
Quidel Corp., of San Diego Solana SARS-CoV-2 assay Isothermal reverse-transcriptase helicase-dependent amplification assay; yields results from up to 11 samples in 25 minutes For the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal and nasal swab specimens Received emergency use authorization from the U.S. FDA

Notes

For more information about individual companies and/or products, see Cortellis.