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