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TransEnterix Announces FDA 510(k) Submission for 3mm Senhance Instruments
Jun. 08, 2018 09:02AM PST
Medical Device InvestingTransEnterix (NYSE American:TRXC), a medical device company that is digitizing the interface between surgeons and patients to improve minimally invasive surgery, today announced the Company filed a FDA 510(k) submission for additional Senhance System instruments including 3 millimeter diameter instruments. As quoted in the press release: The clearance of these instruments would allow the Senhance …
TransEnterix (NYSE American:TRXC), a medical device company that is digitizing the interface between surgeons and patients to improve minimally invasive surgery, today announced the Company filed a FDA 510(k) submission for additional Senhance System instruments including 3 millimeter diameter instruments.
As quoted in the press release:
The clearance of these instruments would allow the Senhance to be used for microlaparoscopic surgeries, allowing surgeons to make tiny incisions that are deemed virtually scarless for patients.
“TransEnterix is the first company to seek FDA clearance for robotically-driven 3 millimeter instruments for abdominal surgery in the U.S.,” said Todd M. Pope, TransEnterix CEO. “We believe Senhance robotic assistance can enable surgeons to expand their use of virtually scarless surgery in more patients, and expands the value that robotics can bring over traditional manual approaches.”