Company Product Description Indication Status
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

Notes

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

No Comments