Minimally invasive surgery device start up Human Xtensions said today it won FDA 510(k) clearance for its HandX device.
The HandX device is a light-weight, handheld device designed to translate a surgeon’s natural hand motions into more complex movements inside the patient, the Israel-based company said.
The device is part of a series of electromechanically-simplified surgical systems the company is developing in a modular format, Human Xtension said. The company also produces smart 5mm surgical tools designed to pass through trocars to improve access and freedom of movement in MIS procedures.
“We believe in technology that gives virtuosic capacity to surgeons. The HandX demonstrates Human Xtensions’ commitment to driving the art of surgery into new frontiers. We are proud to develop solutions that open a new era in surgery, and to serve as the company on the horizon that offers smart multifunctional handheld platforms, suited for a wide range of MIS. By creating technology that is transparent and personalized for each surgeon, surgical teams can now refocus on their patients and on the procedure at hand. Human Xtensions strives to give surgeons the advanced ecosystem they need for taking a giant leap forward, into artefficient surgery,” co-founder, CEO & chair Dr. Tami Frenkel said in a press release.