FDA greenlights ortho robot, automated MRI brain modeling

Dave Pearson | | Radiology Business | Business Intelligence
Green Light

MicroPort Navibot of Foxboro, Mass., is cleared to sell a robotic surgery system that uses CT scan data for planning total knee replacements and precisely placing implants during the operation, the company announced Aug. 8.

Also as of this week, ClearPoint Neuro of Solana Beach, Calif., may market software that automatically identifies, labels and quantifies the volume and shape of brain structures on MRI scans.

MicroPort Navibot’s newly approved system, called SkyWalker, is “capable of providing the surgeon with information that can help to achieve the desired joint line reconstruction while providing data to optimally balance soft tissues,” according to the announcement.  

The company says it plans to develop other orthopedic applications soon.

ClearPoint Neuro’s new offering, Maestro Brain Model, combines malleable surfaces with shapeable models and machine learning algorithms to aid evaluation of patients with mild traumatic brain injury.

The company is building iterations of the current versions with plans to “quantify drug delivery using intraoperative imaging and simulate patient-specific infusions in targeted brain regions,” says ClearPoint Neuro VP Lyubomir Zagorchev, PhD, who previously worked on the platform as an employee of Philips, according to a news release.

Other Recent FDA Approvals of Note:

Prostate AI cleared for U.S. sales
Mobile fluoroscopy machine, DR detector cleared for U.S. sales
Noteworthy FDA approvals of the week: Ceiling-mounted CT angiography, AI for brain-adjacent bleeds
FDA clears AI assessor of stricken dense brain tissue
FDA gives nod to MRI acceleration software equipped with AI
FDA grants IDE clearance for next-phase trial of ‘Flash’ radiation therapy
3D hologram system for guiding precision surgery gets FDA nod
FDA clears 3D print application for head/face and ortho structures
Image-guided spinal surgery system cleared
Pulmonary embolism AI cleared
FDA greenlights expansion of CT-guided, robotically supported IR system
Implantable heart stimulator conditionally cleared for MRI
FDA clears spinal-tap test that could challenge PET in Alzheimer’s diagnostics
FDA greenlights portable, wearable 3D breast POCUS
Dave Pearson
Dave Pearson

Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.

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