|Biofire Diagnostics LLC, of Salt Lake City||Biofire Respiratory Panel 2.1 (RP2.1)||Molecular diagnostic||Simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids, including SARS-CoV-2, in nasopharyngeal swabs||FDA granted marketing authorization via the de novo premarket review pathway; had previously received emergency use authorization, which is no longer in effect|
|Boston Scientific Corp., of Marlborough, Mass.||Therasphere Y-90 Glass Microspheres||Radioembolization technology||Treatment of patients with hepatocellular carcinoma||Received U.S. FDA approval; was previously available under a humanitarian device exemption|
|Braintale SAS, of Paris||Brainquant||Software-as-a-service solution||Provides quantitative measurement of white matter microstructure from brain diffusion MRI||Received CE mark for enhanced version|
|Catalyst Orthoscience Inc., of Naples, Fla.||Reverse shoulder system||Single-tray arthroplasty system||Use in patients experiencing severe shoulder arthritis in conjunction with a grossly deficient or non-functional rotator cuff||Received 510(k) clearance from the U.S. FDA|
|Life Spine Inc., of Huntley, Ill.||Prolift Wedge expandable spacer system||Lordotic expandable implant with Osseo-Loc surface technology||For micro invasive transforaminal lumbar interbody fusion and posterior lumbar interbody fusion procedures||Received 510(k) clearance from the U.S. FDA|
|Stimdia Medical Inc., of Minneapolis||Pdstim system||Electrically stimulates the phrenic nerves in a patient's neck||Facilitates in weaning patients from mechanical ventilation||Received breakthrough device designation from the U.S. FDA|
For more information about individual companies and/or products, see Cortellis.