Myomo gets US nod for "smart" paralysis brace:
This article was originally published in Clinica
The US FDA has approved a noninvasive, wearable, "smart" elbow brace that can help patients whose arms have become paralysed following a stroke relearn how to move their upper limbs. The Myomo e100 NeuroRobotic system, made by Boston, Massachusetts-based firm Myomo, enables patients to self-initiate and control movement of affected limbs using their own biological signals. No electrical stimulation or surgery is required. When a patient's electrical muscle activity signal fires in response to attempted movement, the device senses the signal from the skin's surface. It then employs advanced robotics to "reward" the patient with feedback in the form of actual motion. The theory is that by facilitating the patient's ability to practise tasks repeatedly, new connections are formed in the brain and existing connections are reinforced, resulting in improved ability to move the arm.
You may also be interested in...
A randomized COVID-19 study spanning the whole of the UK could help to bolster the UK’s reputation as a location for future clinical trials. It is also being seen partly as the result of the UK regulator's "decisive action" in fast-tracking trials for potential COVID-19 therapies.
Manufacturers of endoscopic equipment, biofeedback devices and thermometers were among those cited for regulatory violations in US FDA warning letters this week. A total of four device-related enforcement missives were released by the agency.
The biopharma industry has struggled to recruit patients into clinical trials that adequately reflect the diverse patient populations they hope to reach with new products. Failure to improve minority subgroup participation now will cost trial sponsors later.