7D Surgical Expands Spine and Cranial Technology Offering

mJOULE Launches in the United Kingdom Reports Sciton

"Sciton is dedicated to worldwide support and growth. We continue to demonstrate our commitment to developing high quality devices and marketing efforts for our physician and medspa partners worldwide." says Lacee J. Naik, Vice President of Marketing and Public Relations.

FDA Issues Draft Guidance on Remanufacturing and Discussion Paper Seeking Feedback on Cybersecurity Servicing of Medical Devices

With this in mind, the FDA is issuing today's draft guidance to help clarify whether activities performed on medical devices are likely remanufacturing as well as a discussion paper on cybersecurity servicing of devices.

Irrimax Receives FDA Clearance for Irrisept

"This new clearance from the FDA further solidifies Irrisept as the market leader in wound irrigation," said Mark Alvarez, CEO of Irrimax.

7D Surgical announced today important additions to its cranial and spinal product lines. The company has received both 510(k) clearance from the U.S. Food and Drug Administration (FDA) and a medical device license from Health Canada for its Cranial Biopsy Kit, which allows neurosurgeons to use image guidance to accurately target brain lesions during needle biopsy procedures. In their effort to support a wide range of surgical instruments, 7D Surgical is also announcing the commercial release of its Universal Tracking Kit which spine surgeons can use to track and visualize almost any rigid surgical instrument on the MvIGS system, including third-party vendor taps and screwdrivers.

“7D Surgical has successfully transitioned from a start-up organization to a growth company, having launched more than 33 MvIGS programs since our full commercial release a little over a year ago. We are very proud of our team for commercializing these latest products in the spine and cranial markets,” said Beau Standish, CEO of 7D Surgical. “2020 will be another break out year for our Machine-Vision innovations and continued North American and international expansion.”

The 7D Surgical MvIGS system utilizes completely new camera-based technology and machine vision algorithms to eliminate the long-standing frustrations with legacy surgical navigational platforms. The system uses only visible light, eliminating the patient and staff exposure to intraoperative radiation which is common with older technologies. This results in a nearly instantaneous patient registration in almost any surgical position.

“We have completed more than 1,500 clinical cases with the 7D Surgical System and the feedback from our surgeon users has been tremendous.  I am excited to offer these new technologies to our customer base which expands the functionality of the MvIGS system while maintaining our clear advantages in speed and reduced radiation exposure to operating room staff and patients,” said Brian Stuart, Vice-President of Sales & Marketing at 7D Surgical.

spot_img

DON'T MISS

Hyperfine Adds Medtech Leader and Visionary Scott Huennekens as Executive Chairman

Mr. Huennekens’ public boards include Chairman of Acutus Medical (IPO August 2020); Chairman of Envista (IPO September 2019); and board member of Nuvasive. He also serves as a board member and past Chairman of the Medical Device Manufacturer’s Association (MDMA).

One Drop Reports Carrie Siragusa, CPA Appointed VP of Commercial Strategy, Biosensor

Formerly Head of Innovation and Diabetes Portfolio at Sanofi, Siragusa will be part of a team bringing a multi-analyte dermal sensor (biosensor) with continuous health sensing capabilities to market with a mission to provide broader access to continuous glucose monitoring.

Barbara Moorhouse Appointed as Medica Non-Executive Director

Barbara has extensive business and management experience in the private, public, and regulated sectors.

Subscribe to Medical Device News Magazine here.

Related Articles