Company Product Description Indication Status
4D Molecular Therapeutics, of Emeryville, Calif. 4D-310 Gene therapy Fabry disease The U.S. FDA has granted fast track designation
Bayer AG, of Leverkusen, Germany Gadavist (gadobutrol) Imaging Bulk Package Gadolinium-based contrast agent that allows for multipatient dosing For intravenous use in magnetic resonance imaging Received U.S. FDA approval
Hyperfine Research Inc., of Guilford, Conn. Swoop Portable magnetic resonance imaging device Enables bedside visualization of internal structures Received 510(k) clearance from the U.S. FDA
Inmode Ltd., of Lake Forest, Calif. Morpheus8 Full-body subdermal adipose remodeling device For minimally invasive skin and tissue remodeling Received U.S. FDA clearance
Ischemaview Inc. (dba RapidAI), of Menlo Park, Calif. Rapid LVO Uses a vessel tracker in conjunction with assessment of brain regions with reduced blood vessel density For identification of suspected large vessel occlusions (LVOs) Received U.S. FDA clearance
Osprey Medical Inc., of Minnetonka, Minn. Dyevert Power XT Reduces dye dosage without affecting image quality Reduces contrast induced acute kidney injury in patients undergoing angiography Received the CE mark
Quidel Corp., of San Diego Lyra Direct SARS-CoV-2 Assay Real-time RT-PCR assay; uses a reformulated buffer that replaces extraction with a simple 10-minute heat step For the in vitro qualitative detection of human coronavirus SARS-CoV-2 from viral RNA Received Health Canada authorization
Spectronrx, of Indianapolis Hymon SARS-CoV-2 Test Kit Molecular diagnostic For the qualitative detection of nucleic acid from the SARS-CoV-2 in upper respiratory and bronchoalveolar lavage specimens Received expanded emergency use authorization from the U.S. FDA to include use with Applied Biosystems Quantstudio 5 Thermocyclers; earlier authorization specified use with Applied Biosystems 7500 PCR systems only

Notes

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