|Applied Biocode Inc., of Santa Fe Springs, Calif.||Biocode SARS-CoV-2 assay||Molecular in vitro diagnostic; runs on the Biocode MDx-3000||For the qualitative detection of SARS-CoV-2 nucleic acids in respiratory samples including nasopharyngeal swabs, nasal swabs, oropharyngeal swabs and bronchoalveolar lavage||Received emergency use authorization from the U.S. FDA|
|Cae Inc., of Montreal||Cae Air1||Ventilator||Delivers pressure control, volume control and pressure support ventilation using room air or pressured oxygen||Received Health Canada certification|
|Candela Corp., of Wayland, Mass.||CO2re laser||CO2 platform equipped with 6 treatment modes and multiple customized handpieces||For the treatment of genitourinary syndrome of menopause and stress urinary incontinence in adult women||Received Health Canada approval|
|Enexor Health Systems LLC, of Franklin, Tenn.||X-Vent||Emergency ventilator; utilizes a piston driven air system controlled by a Schneider Electric industrial-grade programmable logic computer||Provides invasive and noninvasive ventilatory support for adult patients > 35 kg of weight with respiratory insufficiency or failure||Received emergency use authorization from the U.S. FDA|
|Foundation Medicine Inc., of Cambridge, Mass.||Foundationone Cdx||Comprehensive genomic profiling test for solid tumors||Identifies tumor mutational burden-high patients (≥ 10 mutations/megabase) with unresectable or metastatic solid tumors across all tumor types who could potentially benefit from Keytruda||Received U.S. FDA approval as a companion diagnostic for Keytruda (pembrolizumab, Merck)|
|Tandem Diabetes Care Inc., of San Diego||T:slim X2 pump with Control-IQ technology||Insulin pump with an advanced hybrid closed-loop feature to increase time in range||For the management of diabetes mellitus in people requiring insulin||Received expanded pediatric indication from the U.S. FDA for use in individuals 6 years of age and greater; was previously approved for ages 14 and older|
For more information about individual companies and/or products, see Cortellis.