share
Time to read: 3 minutes

FDA Grants Constant Therapy Health Breakthrough Device Designation for Speech Therapy App

Constant Therapy | Communication disorders

FOR IMMEDIATE RELEASE

Contact:
Constant Therapy Health
P: 1-888-233-1399
support@constanttherapy.com

Digital health innovator’s cognitive linguistics application stands out as first of its kind to receive breakthrough device recognition from FDA 

NEWTON, MA (April 14, 2020) Constant Therapy Health, 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 Constant Therapy Health, 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 Veera Anantha, PhD, President, Co-founder and CEO of Constant Therapy Health. “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 Constanttherapyhealth.com.

###

About Speech Therapy App

Constant Therapy Health’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 Constant Therapy Health’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 Constant Therapy Health

Constant Therapy health 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 Constant Therapy Health’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, and epilepsy. For more information, visit constanttherapyhealth.com.

Twitter
Visit Us
Follow Me
LinkedIn
Share
INSTAGRAM

8 Comments

  1. Vyshnavi

    Hi,

    Is Constant Therapy App and Speech Therapy (ST) App are same or different?

    Best regards

    Reply
    • Constant Therapy

      Hi Vyshnavi, thanks for your question! The ST app (which is still in development) was actually modeled after our publicly available app, Constant Therapy, which you can download today from the App Store, Google Play Store or Amazon store. It contains the same library of speech, language and cognitive therapy exercises. If you’d like to speak to someone about the Constant Therapy app you can contact our support team at 1-888-233-1399 or email support@constanttherapy.com and we can answer your questions and walk you through how to get set up.

      Reply
  2. Elizabeth Eugenio

    Is this provided or supported by my health insurance or do I have to pay for it? everyone want to sell us a product we may not even be able to use.

    Reply
    • Lisa Gundlach

      Hi,Elizabeth- At this time Constant Therapy is not covered by insurance. Two things to note:
      – We have a 14-day free trial to help you figure out if it is a fit for you: https://app.constanttherapy.com/signup/
      Hope this is helpful!

      Reply
  3. Sheharyar Shaikh

    DO YOU HAVE SPEECH THERAPY IN LANGUAGE URDU /hindi

    Reply
    • Constant Therapy

      Thanks for checking. Constant Therapy is not currently available in URDU/hindi.

      Reply
  4. SB

    Shows promise; however, in one section of the CT description, we are informed that it was designed for stroke patients with resultant communication disorders. Later, we are further informed that a mixed group of disorders can benefit from the CT app, including those patients suffering from dementia. Research appears somewhat flawed in conception.

    Moreover, if an AI app is simply supplanting clinician services, why isn’t it covered by insurance (particularly as you already obtained FDA device approval)?

    Unless we’re talking about BCI, there should be no discussion of ‘breakthrough tx’.

    Reply
    • Constant Therapy

      Thank you for your insightful feedback and for highlighting the broad applicability of the Constant Therapy app! Constant Therapy is effectively used to support a diverse range of neurological disorders, including dementia, which is supported by emerging research.

      As you mentioned, Constant Therapy is not intended to replace clinicians but rather to augment the therapy process, providing patients with additional practice and feedback that is essential for recovery outside of regular therapy sessions. As for insurance coverage, it’s an evolving area. While we do have FDA breakthrough designation for stroke, insurance coverage for digital therapy tools like Constant Therapy is still an area of active development. We are continuously working with insurance providers to expand coverage options.

      We appreciate your engagement and are keen to continue these important discussions to improve patient care and accessibility to advanced therapeutic technologies!

      Reply

Submit a Comment

Your email address will not be published. Required fields are marked *