Monday, October 2, 2023
Monday, October 2, 2023

Contact: 561.316.3330

Brainlab Announces Both Loop-X Mobile Imaging Robot and Cirq Robotic Alignment Module for Spine Received FDA Clearance

Brainlab notes following on CE mark approvals last summer, the FDA clearance paves the way for Brainlab to now enter the US markets with the Cirq robotic alignment module for spine procedures, and Loop-X, the first fully robotic intraoperative imaging device on the market.

The first-of-its-kind, Loop-X works seamlessly with the full Brainlab digital surgery portfolio or with a customer’s existing surgical setup. Independently moving imaging source and detector panels enable flexible patient positioning and non-isocentric imaging which reduces the amount of radiation exposure and increases the variety of indications which can be treated. This mobile imaging robot can be controlled wirelessly with a touchscreen tablet. Loop-X was developed in close collaboration between Brainlab and partner medPhoton based in Salzburg, Austria, where the first Loop-X was installed. Hospital San Juan de Dios León in Spain recently performed the world’s first navigated spine surgery using Loop-X mobile imaging robot technology.

Following on the success and growing install base for Cirq, a universal platform for robotic tasks, the new Cirq Robotic Alignment module is capable of fine tuning the alignment to a pre-planned trajectory and freeing up surgeons’ hands, enabling them to focus on the patient’s anatomy. Surgeons at Royal London Hospital in the United Kingdom have already used Cirq Robotic Alignment for a range of cases from routine lumbar fusions to complex deformity and cervical fractures.

“We’re expanding and diversifying our digital surgery portfolio with robotics across all indications,” said Sean Clark, President, Brainlab, Inc. “Our customers want to offer their patients advanced technologies close to home. Brainlab technologies are designed to enable greater freedom for clinicians and enhance outcomes for patients.”

The recent availability of these robotic medical devices is bringing a futuristic vision of the modern digital operating room closer to reality supporting surgeons in their day-to-day work and bringing benefits to their patients.

SourceBrainlab
Medical Device News Magazinehttps://infomeddnews.com
Our publication is dedicated to bringing our readers the latest medical device news. We are proud to boast that our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall purpose and objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

OTHER NEWS

4SC Receives Orphan Drug Designation (ODD) for resminostat (Kinselby) in CTCL from the US FDA

Jason Loveridge, Ph.D., CEO of 4SC, commented: “Receiving orphan drug designation for resminostat provides us with a number of important benefits, most crucially 7 years’ market exclusivity in the US, a key foundation of our efforts to commercialise Kinselby.  We are currently preparing a marketing authorisation application for Kinselby in the EU, which remains on track for submission in Q1 2024.”

Abyrx Receives FDA Clearance for MONTAGE ® Settable Bone Putty for Use in Cardiothoracic Surgery

By expanding the range of FDA-cleared surgical applications for MONTAGE, this latest milestone positions Abyrx to build upon the more than 25,000 units of MONTAGE that have been used to date by surgeons in trauma, orthopedics, sports medicine, foot and ankle, and craniomaxillofacial procedures.

FDA Grants Fast Track Designation to 9MW3011

9MW3011 has been approved to clinical study by NMPA and FDA, respectively. The first person has been dosed in the clinical study in China in March, 2023.

MicuRx receives FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designation for Contezolid and Contezolid acefosamil

"We are pleased to gain the QIDP and Fast Track designations for DFI as recognition that contezolid and contezolid acefosamil are novel new agents to meet an important unmet need in this common and challenging infection", stated Dr Zhengyu Yuan, Chief Executive Officer at MicuRx. 

Via Nova Therapeutics Announces FDA clearance of Investigational New Drug (IND) Application for VNT-101

"We look forward to evaluating VNT-101 in the clinic," said Don Ganem MD, Co-Founder and CEO of Via Nova Therapeutics. "This is an important step to developing a flu antiviral with a novel mechanism of action, and a milestone for Via Nova Therapeutics as we advance our first compound into the clinic."

By using this website you agree to accept Medical Device News Magazine Privacy Policy