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…
Intuitive Surgical wins FDA nod for daVinci X platform
Intuitive Surgical (NSDQ:ISRG) said today it won FDA 510(k) clearance for its new da Vinci X robotic surgical system, with a planned release of the platform later this year. The newly cleared da Vinci X system offers access to multiple robotic-assisted surgical technologies at a lower price than previous models, the Sunnyvale, Calif.-based company said. The…
FDA deals setback to Globus Medical’s ExcelsiusGPS robot-assisted surgery platform
Globus Medical (NYSE:GMED) said yesterday that the FDA won’t accept the 510(k) clearance bid for its ExcelsiusGPS robot-assisted surgery platform, likely delaying its launch until the 3rd quarter. Globus said in a regulatory filing that the federal safety watchdog told it that the company hadn’t “sufficiently addressed the FDA’s questions” about its original clearance application. Audubon, Pa.-based Globus…
Medrobotics wins colorectal indication for Flex robot-assisted surgery system
Medrobotics said today that it won 510(k) clearance from the FDA for a colorectal procedure indication for its Flex robot-assisted surgery platform. The Raynham, Mass.-based company won expanded CE Mark approval in the European Union last October for Flex for performing colorectal procedures. The system won 510(k) clearance from the FDA for transoral procedures in July 2015 (that indication…
TransEnterix files FDA 510(k) application for Senhance, prices $24.9m round
TransEnterix (NYSE:TRXC) said today that it filed an application with the FDA seeking 510(k) clearance for its Senhance robot-assisted surgery platform and priced a $24.9 million funding round. The application is a huge step forward for the company, CEO Todd Pope told MassDevice.com today in a telephone interview. “The most important milestone that we’ve hit now is…
FDA clears Mazor X Align spinal surgical planning software
Mazor Robotics (NSDQ:MZOR) said today it won FDA clearance for its Mazor X Align spinal surgical planning software, with plans to launch in early May. The Mazor X Align software is designed to assist surgeons in planning for spinal deformity correction and spinal alignment procedures with the Mazor X Surgical Assurance platform, the Israel-based company said.…
7 medtech stories we missed this week: March 31, 2017
This week we saw a few FDA 510(k) clearances and one of the 1st uses of a next-generation surgical robot in Asia. Here are 7 medtech stories we missed this week but thought were still worth mentioning: 1. Corindus touts first Asian use of next-generation robot Corindus Vascular Robotics announced in a March 31 press…
Intuitive Surgical warns of risks on Obamacare repeal, NAFTA withdrawal, Brexit
Intuitive Surgical (NSDQ:ISRG) last week warned of the risks posed to its business by the geopolitical shifts of the past year, including the likely repeal of Obamacare, the U.S.’s threatened abrogation of the North American Free Trade Agreement and Great Britain’s pending exit from the European Union. Uncertainty around Obamacare repeal In its annual report filed…