|Diatherix Eurofins LLC, of Huntsville, Ala.||SARS-CoV-2 assay||Lab-developed test that uses target enriched multiplex polymerase chain reaction technology||Fior the qualitative detection of nucleic acid from SARS-CoV-2 in nasal swabs, nasopharyngeal swabs/wash, oropharyngeal swabs/throat swabs, bronchial aspirates, or sputum||Received emergency use authorization from the U.S. FDA|
|Medtronic, of Dublin||Carpediem system||Continuous renal replacement therapy device||Provides continuous hemodialysis or hemofiltration therapy to critically ill pediatric patients weighing between 2.5 and 10 kg (or 5.5 to 22 lbs)||Received marketing authorization from the U.S. FDA via the de novo premarket review pathway|
|Photopharmics Inc., of American Fork, Utah||Phototherapy device||Noninvasive, in-home device||Treatment for Parkinson's disease||Received breakthrough device designation from the U.S. FDA|
|Psychemedics Corp., of Acton, Mass.||Psychemedics Microplate EIA for Cotinine In Hair||Enzyme immunoassay||Detects nicotine use||Received 510(k) clearance from the U.S. FDA|
|Senseonics Holdings Inc., of Germantown, Md.||Eversense XL Sensor||Implantable continuous glucose monitoring system||Continually measures glucose levels in patients with diabetes||Received MRI conditional approval from a European notified body|
|Vuno Inc., of Seoul, South Korea||Vuno Med-LungCT AI||Artificial intelligence (AI) solution for chest computed tomography (CT) scans||Detects pulmonary nodules as a way to screen for early stage lung cancer||Approved by the Ministry of Food and Drug Safety in South Korea|
For more information about individual companies and/or products, see Cortellis.