Developing Devices for Disabled Patients with FDA Encouragement
From: Medical Design Technology - 11/04/2104
By: William Maisel, MD, MPH, Deputy Center Director for Science, FDA

In recent months, FDA has reviewed a number of noteworthy products for people
with disabilities. And it has approved, cleared or allowed manufacturers to
market several new devices.

Products that have met FDA's premarket requirements include:

The DEKA Arm System, the first prosthetic arm that can perform multiple,
simultaneous, powered movements controlled by electrical signals from
electromyogram (EMG) electrodes;

The Nucleus Hybrid L24 Cochlear Implant System, which can help people aged 18
and over (who don't benefit from conventional hearing aids) with a specific
kind of hearing loss; and

The Argus II Retinal Prosthesis System, the first implanted device to treat
adult patients with vision loss from advanced retinitis pigmentosa (RP).

Each of the products recently approved or cleared by the agency has benefits
that outweigh its risks. For example, in June we allowed marketing of ReWalk,
a first-of-its-kind, motorized device. Risks associated with the
exoskeleton-like device include pressure sores and injuries from falls. But
the big benefit is that it can help patients with complete or partial
paraplegia to actually walk in their homes and communities. 

Read the entire article at:
http://www.mdtmag.com/blogs/2014/11/developing-devices-disabled-patients-fda-encouragement
http://blogs.fda.gov/fdavoice/index.php/2014/10/fda-encourages-development-of-devices-for-patients-with-disabilities/

Links:
DEKA Arm System
http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm396688.htm

Nucleus Hybrid L24 Cochlear Implant System
http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm389860.htm

Argus II Retinal Prosthesis System
http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm339824.htm

ReWalk
http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm402970.htm