Company Product Description Indication Status
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authorization via the de novo premarket review pathway; had previously received emergency use authorization, which is no longer in effect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

Notes

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