TransEnterix is changing its name and slightly altering its mission in surgical robotics. The Research Triangle Park, NC-based company will be named Asensus Surgical and will start trading under the new ticker symbol, NYSE American: ASXC starting March 5. The company said the name change reflects the company's broader vision of shaping the future of surgery by integrating computer vision and machine learning with surgical robotics. It also reflects the company’s mission of opening up a new category of procedures, performance-guided surgery.
Medtronic Recalls Valiant Navion
A safety issue observed during a global clinical trial has prompted Medtronic to issue a global recall of unused Valiant Navion thoracic stent graft systems. In the interest of patient safety, the company has told physicians to immediately stop using the device until further notice. Medtronic said three patients in the Valiant Evo trial were observed to have stent fractures. Two of those patients have confirmed type IIIb endoleaks, and one patient has died.
And in case you missed our last Medtech in a Minute report...
Nearly one year ago, FDA allowed many antibody tests to be sold and shipped unreviewed. It was an effort to get tests onto the market as quick as possible to deal with growing threat of COVID-19. In an editorial published in The New England Journal of Medicine, FDA officials admitted this measure was a mistake.
Guardant Health launched a liquid biopsy test for the detection of residual and recurrent colorectal cancer. The Guardant Reveal is considered the industry's first blood-only test designed to detect, with seven-day turnaround time, residual disease after surgery and recurrence months earlier than current standard-of-care methods. In other liquid biopsy news, Personal Genome Diagnostics raised $103 million in a series C round to help with the advancement of its tissue and liquid biopsy tests.
FDA cleared AlifeCor's technology for an expanded range of ECG determinations and had research with Mayo Clinic published in the peer-reviewed journal Circulation. AliveCor's KardiaMobile, a robust heart monitoring solution backed by strong data, is available on Amazon.