Company Product Description Indication Status
Brainsway Ltd., of Jerusalem Deep TMS system Transcranial magnetic stimulation (TMS) device For use as an aid in short-term smoking cessation in adults Received 510(k) clearance from the U.S. FDA
Guardant Health Inc., of Redwood City, Calif. Guardant-19 Reverse transcriptase polymerase chain reaction next-generation sequencing test Detection of the novel coronavirus U.S. FDA granted emergency use authorization
Helixbind, of Boxborough, Mass. Rapid/BSI First test for the Rapid platform Identifies the most common bloodstream infections (BSIs) associated with sepsis Awarded breakthrough device designation from the U.S. FDA

Notes

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

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