Boston Scientific has agreed to acquire the surgical business of Lumenis for an upfront cash payment of $1.07 billion. Subject to close in the second half of the year, the deal includes Lumenis' energy-based medical solutions (laser systems, fibers and accessories) used in urology and otolaryngology procedures.
Medtronic is recalling the pump implant kit for its HeartWare Ventricular Assist Device after two deaths and many serious injuries were reported. This is the company's second HeartWare-related recall in about a year, and one of several in the device's history. The latest recall is because the device may fail to initially start, restart, or have a delay in restarting after the pump stops, according to a recent FDA MedWatch report.
FDA authorized marketing of a robot-assisted surgical device designed to help facilitate transvaginal hysterectomy in certain patients. Developed by Tel Aviv, Israel-based Memic Innovative Surgery, the Hominis Surgical System is intended for benign hysterectomy (removal of the uterus for non-cancerous conditions) with salpingo-oophorectomy (removal of one or both fallopian tubes and ovaries). Hominis is also the first robot-assisted surgical device with arms designed to replicate the motions and capabilities of a surgeon's arms, with shoulder, elbow, and wrist joints, allowing the surgical robot device to access and reach through areas not possible with other robots.
And in case you missed our last Medtech in a Minute report...
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.
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.
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.