Mendaera has received FDA 510(k) clearance for its Focalist handheld robotic system, which enhances the precision of ultrasound-guided needle placement across multiple specialties.
For over a century, surgeons performing delicate procedures have relied on stereoscopic microscopes to gain a sense of depth. These tools mimic human vision by presenting slightly different images to each eye, allowing the brain to perceive three-dimensional structures—a crucial aid when working with fragile blood vessels or intricate brain tissue. Despite modern upgrades like digital displays and video capture, today’s operating microscopes still depend on the same core principle: two views, interpreted by the human brain.
Intuitive Surgical (Nasdaq: ISRG)+
announced today that it received CE mark for its da Vinci 5 surgical robotic system.
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Levita Magnetics announced today that it received expanded FDA 510(k) clearance for its MARS (magnetic-assisted robotic surgery) system.
Brain Navi Biotechnology announced today that it received FDA 510(k) clearance for its NaoTrac stereotaxic guiding surgical robotic device.
Johnson & Johnson MedTech (NYSE: JNJ)+
today announced the U.S. launch of its Ethicon 4000 surgical stapler.
Distalmotion announced today that it received FDA 510(k) clearance for the use of its Dexter surgical robot in adult cholecystectomy (gallbladder removal).
The company said in a news release that the latest clearance marks a significant step forward in gastrointestinal (GI) motility monitoring. It offers clinicians an advanced, non-invasive tool for assessing whole-gut transit times with unmatched accuracy and patient comfort.