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You may recall an article about Ekso Bionics that we published back in March 2014. It profiled the wearable bionic suit developed by the Richmond, CA–based company that helps people with a lower-extremity weakness, even those who suffer from spinal cord injuries, to stand up and walk. This technology is doing good, and the device looks pretty damn cool, to boot.

Norbert Sparrow

December 8, 2014

2 Min Read
Ekso Bionics webcasts technology day

You may recall an article about Ekso Bionics that we published back in March 2014. It profiled the wearable bionic suit developed by the Richmond, CA–based company that helps people with a lower-extremity weakness, even those who suffer from spinal cord injuries, to stand up and walk. This technology is doing good, and the device looks pretty damn cool, to boot. See for yourself: The company will host a technology and development day tomorrow, which it is webcasting. Ekso Bionics has also been in the news of late.

ekso-bionics-1412-250.jpgFirst off, the company raised $22.8 million last week to further market and ramp up sales of its exoskeleton for those with impaired movement, but the funds will also go toward developing able-bodied applications, according to CEO Nathan Harding, as reported by MedCity News. Beyond the medical and therapeutic applications of its technology, Ekso's hydraulic-powered Human Universal Load Carrier (or HULC, one letter short of a marvel of an invention) is being looked at by Lockheed Martin for military and industrial use. The device could help able-bodied soldiers carry up to 200 pounds of gear without fatigue.

So, that's good. But what about an announcement earlier this month from Ekso that FDA wants it to submit a 510(k)? A 510(k), or premarket notification, requires demonstration of substantial equivalence to a predicate device or compliance with special controls established by FDA. Ekso has said that it has submitted the 510(k) to FDA and that the agency will allow it to continue marketing the product while the filing is under review. The company is required, however, to notify its customers that its application is under review. According to the Regulatory Affairs Professionals Society (RAPS; Rockville, MD), FDA may have had second thoughts about potential safety risks associated with the exoskeletons and cites the classification of stair-climbing wheelchairs as an example.

"Unlike hand-operated wheelchairs, which are considered Class I medical devices, the mechanical complexity and more advanced use of stair-climbing wheelchairs present novel safety risks," writes RAPS. "For example, FDA expressed concern that a mechanical failure could cause a user to suffer a bad fall (such as down a flight of stairs), become trapped, have an allergic reaction to materials used in the device, or be burned or shocked by a battery failure. Regulators may well have similar concerns about the Ekso device, which is used in similar patient populations and situations," according to RAPS.

Ekso is taking all of this in stride and at this moment is putting the finishing touches on tomorrow's technology and development day, which will be held from 7:30 to 10:30 AM Eastern time. The presentation featuring the company's industrial and medical exoskeleton technology will be webcast live and also will be made available on demand on the company's website.

About the Author(s)

Norbert Sparrow

Editor in chief of PlasticsToday since 2015, Norbert Sparrow has more than 30 years of editorial experience in business-to-business media. He studied journalism at the Centre Universitaire d'Etudes du Journalisme in Strasbourg, France, where he earned a master's degree.

www.linkedin.com/in/norbertsparrow

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