The Sport surgical system, which is intended for minimally invasive gynecological procedures, has been put on hold as Titan Medical looks for more money for R&D and regulatory submissions.
TSolution One robot for total knee replacement receives FDA approval
Think Surgical enters a competitive orthopedic surgery market with U.S. approval for the use of its TSolution One surgical robot for total knee replacement.
Titan Medical delays Sport surgical robot timeline
Titan Medical has delayed plans for submitting its Sport robotic surgical system to work on further development and funding.
Corindus Vascular Robotics to be acquired by Siemens Medical Solutions for $1.1B
Corindus Vascular Robotics, whose CorPath GRX has FDA approval for percutaneous coronary and vascular procedures, will be acquired by Siemens Healthineers.
Myomo scales up production, training for MyoPro device for upper-body mobility
Myomo is working with contract manufacturers for its MyoPro assistive devices, which use sensors, algorithms, and motors to help wearers regain upper-limb function.
AdventHealth is first in Florida to use TransEnterix surgical robot for gynecological procedures
Robot-assisted surgery is growing, as new technology enables applications for additional operations. AdventHealth for Women in Florida is an early user of TransEnterix’s Senhance for gynecological procedures.
Robotic catheter brings autonomous navigation into human body
Boston researchers recently demonstrated a robotic catheter that could autonomously navigate through the body to repair a cardiac valve.
Food robotics pioneers take orders for growing industry appetite
Attendees and speakers at a food robotics event in San Francisco discussed the biggest challenges facing developers and users of robots and AI for cooking, delivery, and tracking.
Intuitive Surgical da Vinci SP robot wins clearance for new procedures
Intuitive Surgical won another indication from the Food and Drug Administration (FDA) for its da Vinci SP robot-assisted surgery device. The Sunnyvale, Calif.-based company said the FDA added single-port radical tonsillectomy and tongue base resection procedures to the mix. Initially cleared in April 2014 for urological procedures, in June 2018 the federal safety watchdog added a clearance…
FDA warns about using surgical robots for cancer treatment
Keynotes | Speakers | Exhibitors | Register The U.S. Food and Drug Administration (FDA) has issued a warning against the use of surgical robots in mastectomies and other surgeries for the treatment or prevention of cancer. The FDA said the safety and effectiveness of surgical robots have not been established for use in mastectomies or…
Ion lung biopsy system from Intuitive Surgical wins FDA approval
Intuitive Surgical Inc. yesterday said that the U.S. Food and Drug Administration approved its Ion system. The robotic endoluminal system is designed to enable doctors to conduct minimally invasive biopsies deep within the lung. Ion includes an articulating robotic catheter with an outer diameter of only 3.5 mm that is able to move 180 degrees in…
Corindus submits CorPath GRX to FDA for robotic neurovascular interventions
Corindus Vascular Robotics this week said it applied to the U.S. Food and Drug Administration for premarket clearance to use its CorPath GRX robotic surgical platform in neurovascular interventions. The Waltham, Mass.-based company has already received FDA clearance for percutaneous coronary interventions (PCI), which it won in 2016, and for peripheral vascular interventions (PVI), which it won last…
TransEnterix Senhance surgical robot gets approved for new procedures
TransEnterix has won expanded indications from the Food and Drug Administration for its Senhance robot-assisted surgical system. The system is now cleared for hernia and gallbladder procedures. There are approximately 760,000 inguinal hernia and 1.2 million laparoscopic cholecystectomy procedures performed annually in the U.S. With this clearance, the system’s total addressable annual procedures in the…
Auris Health Wins FDA Approval for Monarch Surgical Robot
Auris Health, previously known as Auris Surgical Robotics and formed by Intuitive Surgical (NSDQ:ISRG) founder Dr. Frederic Moll, won FDA clearance for its Monarch robotic endoscopy platform. The Redwood City, Calif.-based company said it’s Monarch robotic platform’s initial aim will be on treating lung cancer, with the FDA clearance indicating the device for use in…
Regulatory Challenges Holding Back Healthcare AI
It was the last question of the night, and it hushed the entire room. An entrepreneur expressed his aggravation about the US Food and Drug Administration’s (FDA) antiquated regulatory environment for AI-enabled devices to Dr. Joel Stein of Columbia University. Stein, a leader in rehabilitative robotic medicine, sympathized with the startup, knowing that tomorrow’s exoskeletons…
Renishaw wins FDA approval for neurosurgery planning software
Renishaw, a British engineering company, received approval by federal officials to sell the latest version of its neurosurgery planning software in the U.S. The FDA granted 510(k) clearance for Renishaw’s neuroinspire software that blends MRI and CT datasets into a 3D volume, enabling neurosurgeons to identify and outline regions of interest. The approach is designed…
TransEnterix CEO Pope, riding high on FDA nod, eyes the laparoscopic surgery market
Share prices for TransEnterix (NYSE:TRXC) have more than doubled since the robot-assisted surgery company won an important clearance from the FDA last week and CEO Todd Pope is optimistic about his companies chances against the undisputed market leader, Intuitive Surgical (NSDQ:ISRG). Morrisville, N.C.-based TransEnterix, which acquired Senhance for $100 million in September 2015, finalized its clearance bid last…
TransEnterix wins FDA nod for Senhance robot-assisted surgery platform
TransEnterix (NYSE:TRXC) said last week that it won 510(k) clearance from the FDA for its Senhance robot-assisted surgery platform. TransEnterix, which acquired Senhance for $100 million in September 2015, finalized its clearance bid last month after applying in April. “The clearance of the Senhance system in the U.S. is a milestone in the progress of robotics and is…
TransEnterix responds to FDA more info request
Robotics medical company TransEnterix filed its response to the Food and Drug Administration’s additional information request on its Senhance Surgical Robotic System 510(k) submission. The Senhance robotic-assisted surgery system is designed to improve minimally invasive surgery, namely in laparoscopy operations, through haptic feedback and eye sensing camera control. “We are very pleased to have submitted…
Globus Medical jumps on FDA nod for Excelsius GPS robot-assisted surgery platform
Globus Medical (NYSE:GMED) said today that it won 510(k) clearance from the FDA for its long-awaited Excelsius robot-assisted surgery platform, which is designed to integrate intra-operative CT and fluoroscopic imaging technologies. Audubon, Pa.-based Globus said the clearance covers minimally invasive and open orthopedic and neurosurgical surgeries, including screw placement in spinal and orthopedic procedures. The system won CE…
7 medtech stories we missed this week: July 21, 2017
From Second Sight’s South Korean market entry to Sanuwave’s Indonesian distribution deal, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Second Sight enters South Korea market Second Sight announced in a July 5 press release that it has entered the market in South Korea with the implantation…
Intuitive Surgical wins FDA nod for inguinal hernia repairs with da Vinci Xi
Update: Removed information claiming benefits of robotic hernia surgeries at request of Intuitive Surgical, which said that the data came from an inaccurate source and was not valid. Intuitive Surgical (NSDQ:ISRG) said today it won FDA clearance for inguinal hernia repairs with its da Vinci Xi robotic surgical system. Inguinal hernias occur when tissue presses through…