Updated to include share prices TransEnterix (NYSE:TRXC) said today that the FDA responded to the 510(k) application for its robotic surgery SurgiBot system, saying that the platform does not meet the criteria for substantial equivalence based on the data and information in the application. Research Triangle Park, N.C.-based TransEnterix claims SurgiBot as the 1st patient-side robotically enhanced laparoscopy […]
TransEnterix
TransEnterix pushes Surgibot decision date back
TransEnterix (NYSE:TRXC) yesterday said the FDA isn’t finished reviewing the 510(k) application for its SurgiBot robot-assisted surgery device, meaning the decision it had expected to come during the 1st quarter isn’t likely to happen until mid-April. Research Triangle Park, N.C.-based TransEnterix claims SurgiBot as the 1st patient-side robotically enhanced laparoscopy platform, designed to be wheeled to a patient’s […]
Analyst: Medtronic most likely to challenge Intuitive Surgical in robot-assisted surgery
Medtronic (NYSE:MDT) is the most likely rival to Intuitive Surgical‘s (NSDQ:ISRG) dominance in the robot-assisted surgery space, but is still at least a year away from putting a competing device on the market, according to 1 analyst covering the medical device industry. Sunnyvale, Calif.-based Intuitive has a long lead, having had its flagship da Vinci system since 2000 and is […]
TransEnterix finalizes response to FDA over 510(k) for SurgiBot
TransEnterix (NYSE:TRXC) said today it finalized its response to the FDA in relation to the 510(k) application for its SurgiBot system. Research Triangle Park, N.C.-based TransEnterix says the SurgiBot is the 1st patient-side robotically enhanced laparoscopy platform, designed to be wheeled to a patient’s bedside and operate through a single port. “We are pleased to have […]
TransEnterix surges on takeover speculation
TransEnterix (NYSE:TRXC) shares surged today on speculation that the robot-assisted surgery company could be acquired by Johnson & Johnson (NYSE:JNJ). Johnson & Johnson chairman & CEO Alex Gorsky said this week that the healthcare conglomerate stayed off the mergers & acquisitions trail last year because valuations were too high. That’s not the case this year, Gorsky […]
Intuitive Surgical CEO Guthart unfazed by upcoming competition
Gary Guthart, the longtime CEO of robot-assisted surgery pioneer Intuitive Surgical (NSDQ:ISRG), said yesterday that he’s confident Intuitive will be able to compete as smaller rivals begin hitting the market as early as this year and bigger players loom on the horizon. “We have known for years and have anticipated for years. We didn’t wake up yesterday […]
Angiodynamics CFO Frost resigns, moves to Analogic | Personnel Moves
AngioDynamics (NSDQ:ANGO) said today its CFO and exec veep Mark Frost resigned from his position to join Analogic (NSDQ:ALOG) as senior veep, treasurer & CFO. AngioDynamic’s veep and global controller Michael Trimach will serve as Interim CFO as the company searches for a permanent replacement. The Albany, N.Y.-based company said Frost will stay on to facilitate a smooth […]
TransEnterix puts up $100m for Sofar’s ALF-X robot-assisted surgery device
TransEnterix (NYSE:TRXC) said yesterday that it acquired the Telelap ALF-X robot-assisted surgery device from Italy’s Sofar SpA in a deal worth $99.8 million. The Telelap ALF-X device has CE Mark approval in the European Union for minimally invasive surgery procedures. Research Triangle Park, N.C.-based TransEnterix makes the SurgiBot robot-assisted surgery device. The deal included $25 million in up-front […]
Philips Healthcare’s India chief takes over new emerging markets biz | Personnel Moves
Royal Philips (NYSE:PHG) has promoted its India managing director and CEO Krishna Kumar to a position managing its emerging healthcare business division, according to The Times of India. Kumar is slated to continue as managing director of Philips India division until December, at which point he will lead the development of consumer and profesisonal healthcare […]
TransEnterix offering goes over-allotment, raises $52m
TransEnterix (NYSE:TRXC) said today it exercised an underwriter’s over-allotment option for its most recent funding round, selling an extra 2 million shares of common stock at the public offering price of $3 per share. Stifel and RBC Capital Markets were book-runners for the round, with Raymond James, BTIG and Ladenburg Thalmann as co-managers. Proceeds from the original sale of […]
TransEnterix opens $50m follow-on funding round
TransEnterix (NYSE:TRXC) said yesterday that it’s looking for $50 million from a follow-on offering of common stock to finance the sales and marketing of its SurgiBot robot-assisted surgery device. The Research Triangle Park, N.C.-based company has not yet revealed the amount of shares, share price or date the offering will open. Stifel and RBC Capital Markets will be […]
