Company Product Description Indication Status
Reflexion Medical, of Hayward, Calif. Reflexion X1 Biology-guided radiotherapy system; combines fan-beam computed tomography with a linear accelerator For stereotactic body radiotherapy, stereotactic radiosurgery and intensity modulated radiotherapy in the treatment of tumors Received marketing clearance from the U.S. FDA
Roche Group, of Basel, Switzerland Cobas SARS-CoV-2 test Real-time RT-PCR test that runs on the Cobas 6800/8800 systems For the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in nasopharyngeal and oropharyngeal swab samples Received U.S. FDA emergency use authorization for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988
Transenterix Inc., of Morrisville, N.C. Intelligent Surgical Unit Enables machine vision of the camera for a surgeon using the Senhance robotic system Intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue in gynecological surgery, colorectal surgery, cholecystectomy and inguinal hernia repair Received 510(k) clearance from the U.S. FDA

Notes

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

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