Company Product Description Indication Status
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

Notes

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