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Human Xtensions secures FDA approval for HandX smart digital handtop solution

Published 26 March 2018

Human Xtensions, a tartup company that develops handheld digital solutions for minimally invasive surgery (MIS), has received FDA 510 (k) clearance for HandX.

The smart, electromechanically-simplified surgical systems by Human Xtensions integrate all the components required for a modular platform, of which HandX is the first to be launched and be FDA cleared.

 HandX is designed as a light-weight, hand-held device that translates the surgeon's natural hand motions into complex movements inside the patient.

During MIS, Human Xtensions smart 5mm surgical tools pass through trocars, making much more possible in each MIS procedure, both in terms of access and natural freedom of movement. This also opens vast new horizons for converting open surgery into MIS, which expedites patient recovery and drastically improves outcomes.

Moreover, the HandX is suited for any skill level, and offers hospitals of all sizes an affordable cost-effective alternative to the heavyweight robotic systems that are operated remotely.

Human Xtensions co-founder, chairman, and CEO Dr Tami said: "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."

Human Xtensions is a medical device company, focusing on reinventing minimal invasive surgery (MIS) with disruptive handtop technology.

 Founded in 2012 with the vision of making MIS a smart art, Human Xtensions is headquartered in Israel and led by a multidisciplinary team of professionals that bring the best of all worlds, from medicine to technology, and from ergonomics to design.

Human Xtensions catalyzes an entirely new medical reality called Artefficient Surgery, with personalized digital platforms that combine the power of surgical robotics with the ease and affordability of hand-held solutions.

Source: Company Press Release