FDA Approves Robotic Arm Device for Stroke Survivors

Federal regulators have granted clearance to market a robotic arm brace designed to help stroke survivors regain use of paralyzed limbs and relearn how to move affected muscles, the device's maker said Tuesday.

Myomo Inc. said it would begin marketing the e100 NeuroRobotic System to rehabilitation clinics and medical specialists now that it has Food and Drug Administration clearance.

The lightweight brace slides onto an arm. Sensors placed on the front and back parts of the upper arm detect slight muscle contractions. That triggers a motor — contained in a backpack that the user also wears — that allows the user to control the arm's movement.

Unlike other devices to help stroke survivors regain mobility, no electrical stimulation or invasive procedures are required, Myomo says. Rather, the device helps individuals use their own biological signals to recover muscle control.

The destruction of brain cells from a stroke causes loss of function. The researchers say with repetitive therapy, other neurons can take over some of the lost function.

Boston-based Myomo — whose name is an acronym for "My Own Motion" — developed the arm based on research by two Massachusetts Institute of Technology graduates who won a $50,000 MIT business plan competition in 2004. Myomo is the privately held company that the MIT grads, John McBean and Kailas Narendran, are using to market the device.

The device is expected to cost $5,000 to $10,000, with specific pricing information forthcoming, said Maureen Liberty, a Myomo spokeswoman. The company isn't making sales projections.

The device is intended for use in clincal settings, and hasn't yet been shown to be safe or effective for home use, the company said. Clinical studies haven't demonstrated any known side effects or risks for stroke patients in therapy.