NEWTON, Mass.--(BUSINESS WIRE)--The Learning Corp, an award-winning digital therapeutics provider, today announced that it has received Breakthrough Device designation from the United States Food and Drug Administration (FDA) for its Speech Therapy (ST) App, which is designed to provide accessible cognitive, speech and language therapy to stroke patients.
The first cognitive linguistics application to achieve this status by FDA, ST App’s Breakthrough Device designation is also the first for The Learning Corp, which combines AI and real-world evidence to deliver next-generation brain health products and research. ST App is designed as an accessible, home-based therapy solution for patients that also allows clinicians to check in remotely on progress.
“We are thrilled that FDA has decided to grant Breakthrough Device designation to our ST App, and we look forward to collaborating with the Agency on expediting development of our therapeutic to market,” said Shaheen Lakhan, MD, PhD, Vice President of Research and Development at The Learning Corp. “This designation marks not only a milestone for our company, but the next step in empowering patients to take control of their brain health by improving access to care.”
Per FDA, the Breakthrough Devices Program is for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. For ST App, the designation applies to patient use in the post-discharge phase to improve cognitive, speech and/or language abilities in adults who have suffered a stroke resulting in related deficits. According to the CDC, every year an estimated 795,000 Americans will have a stroke and more than 180,000 will be left with communication disorders like aphasia, a neurological condition that impairs the production or comprehension of speech and language.
For more information, please visit thelearningcorp.com.
About Speech Therapy App
The Learning Corp’s Speech Therapy (ST) App is a digital therapeutic designed to provide accessible cognitive, speech and language therapy to stroke patients. The application is modeled to provide systematic and structured therapy analogous to what is typically provided by a speech-language pathologist (SLP), and can be accessed by the patient from any location using a supported device. ST App is powered by The Learning Corp’s leading-edge NeuroPerformance Engine™ (NPE), the patented AI at the core of all of the company’s products, including its award-winning cognitive therapy platform Constant Therapy.
About The Learning Corp
The Learning Corp is a leading digital therapeutics company that combines AI and real-world evidence to deliver next-generation brain health and wellness products. The company created Constant Therapy, an app that gives its tens of thousands of users with brain injuries or cognitive disorders direct access to clinically proven exercises that can help them rebuild their cognitive and speech functions. As the discovery platform for developing The Learning Corp’s digital therapeutics, Constant Therapy can be adapted for investigational trials and customized for potential care delivery across a multitude of CNS conditions involving speech, language, and/or cognitive deficits such as acquired brain injuries (stroke, traumatic brain injury), mild cognitive impairment, dementia, multiple sclerosis, Parkinson’s disease, major depressive disorder and epilepsy. For more information, visit thelearningcorp.com.