Company Product Description Indication Status
Abbott Laboratories of Abbott Park, Ill. Triclip Transcatheter tricuspid valve repair system Nonsurgical treatment for people with tricuspid regurgitation Received the CE mark
Cipla Ltd., of Mumbai Albuterol inhaler Generic of Proventil HFA (albuterol sulfate) metered dose inhaler, 90 mcg/Inhalation Treatment or prevention of bronchospasm in patients four years of age and older Received approval from the U.S. FDA
Diacarta Inc., of Richmond, Calif. Quantivirus PCR diagnostic test Real-time quantitative reverse transcriptase PCR assay for use on Applied Biosystems 7500 and Quantstudio 5; produces results within 2 hours following RNA extraction Detects the N, Orf1ab and E genes of SARS-CoV-2 in nasopharyngeal swabs, oropharyngeal swabs and sputum samples Received emergency use authorization from the U.S. FDA
DNAe Group Holdings Ltd., of London Lidia-SEQ Direct-from-specimen platform that performs genomic analysis on a microchip Tests for bloodstream infections and antimicrobial resistance to identify infections that can lead to sepsis Received breakthrough device designation from the U.S. FDA
Vapotherm Inc., of Exeter, N.H. Oxygen Assist Module Algorithm-based module for use with most versions of Vapotherm's Precision Flow systems Maintains oxygen saturation in target range Received breakthrough device designation from the U.S. FDA
Silk Medical Aesthetics Inc., of Boston Injectable form of Evolved By Nature's Activated Silk Silk-based dermal filler For use in the nasolabial fold of the face for volume correction Received investigational device exemption from the U.S. FDA to initiate a human clinical trial

Notes

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

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