Remote robotic system for endovascular procedures
Microbot Medical received FDA 510(k) clearance for its LIBERTY Endovascular Robotic System, the first FDA-cleared single-use, remotely operated robotic system for peripheral endovascular procedures. The company has since commenced a limited market release of the system, which they believe has potential to enhance procedure efficiency, lower costs, and improve overall quality of care.
The LIBERTY pivotal study showed 100% success in robotic navigation to target and zero device-related adverse events. It also showed a 92% relative reduction in radiation exposure for physicians. Its remote design is expected to improve ergonomics, aiding in reducing the physical strain on healthcare providers.
Microbot Medical
https://microbotmedical.com
Hybrid endoscope
Outlook Surgical obtained FDA clearance of its Inova 1 Towerless Endoscope System, overcoming the limitations of traditional surgical endoscopy by combining the best features of rigid and flexible scopes in one platform. For more than 30 years, surgical endoscopy has relied on either rigid or flexible scopes, each with inherent limitations. Rigid endoscopes provide precision but lack maneuverability, while flexible scopes allow navigation but require two-handed operation.
Specifically designed for head and neck procedures, the Inova 1 Hybrid Endoscope is designed to work hand-in-hand with existing surgical instruments. Instruments can attach directly to the scope, enabling one-handed operation while ensuring the working tool remains continuously in the field of view. Its design eliminates the need for bulky external towers, cameras, or light sources, making the device lighter, thinner, and more portable than existing systems.
Outlook Surgical
https://www.outlooksurgical.com
Full-body weight-bearing CT scanner
Planmed is introducing its Planmed XFI to the U.S. market after receiving FDA 510(k) clearance. The full-body weight-bearing CT scanner uses cone beam computed tomography (CBCT) to image the entire body in an upright or supine position. The scanner is designed to find subtle fractures and misalignments during the first visit to the clinic. CBCT technology offers insights into conditions commonly missed when only using conventional methods, such as 2D radiographs.
Planmed XFI can detect problems not apparent when the body is at rest; it provides fast 3D imaging at the point of care. The scanner delivers ultra-high resolution and patient adaptability and can be used for both pre- and postoperative imaging.
Planmed
https://www.planmed.com
Transcatheter aortic valve replacement system
Medtronic received U.S. Food and Drug Administration (FDA) approval for the expanded Redo-TAVR indication of the Evolut transcatheter aortic valve replacement (TAVR) system. This approval allows for the implantation of a new Evolut transcatheter aortic valve (TAV) inside any failed previously implanted TAV and follows CE (Conformité Européenne) Mark for Evolut PRO+, FX, and FX+ systems.
The Redo-TAVR procedure is indicated for patients experiencing failure of any TAV, including but not limited to severe aortic stenosis, who are at high risk for open-heart surgery.
Medtronic
https://www.medtronic.com
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