Company Product Description Indication Status
Binx Health Inc., of Boston, Binx Io Molecular point-of-care testing platform Detection of chlamydia and gonorrhea in vaginal swab and male urine specimens Received expanded 510(k) clearance from the U.S. FDA for detection in male urine specimens
Cerus Endovascular Ltd., of Fremont, Calif. 021 Contour Neurovascular System A fine mesh braid that is deployed across the neck of the aneurysm sac Treatment of saccular intracranial aneurysms Received CE mark approval
Nines Inc., of Palo Alto, Calif.  NinesAI Artificial intelligence (AI)-based software Supports the automated radiological review of CT head images for the possible presence intracranial hemorrhage and mass effect to aid radiologists in triaging case Received U.S. FDA clearance
Refine USA LLC, of Jacksonville, Fla. Rejuvapen Nxt Microneedling device For wrinkle reduction and aesthetic use Received 510(k) clearance from the U.S. FDA 
Rheonix Inc., of Ithaca, N.Y. Rheonix COVID-19 MDx Assay Automated RT-PCR assay for the Rheonix Encompass MDx workstation; provides same-day test results For the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory samples Received emergency use authorization from the U.S. FDA
Synaptive Medical Inc., of Toronto  Evry Superconducting, head magnetic resonance imaging  technology For diagnostic imaging  at the point of care in critical care settings Received U.S. FDA clearance

Notes

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

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