AI-enabled chatbot Wysa receives FDA Breakthrough Device designation for patients with chronic pain, depression and anxiety

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AI Behav­ior Health Chat­bot App Fast-Tracked by FDA (Psy­chol­o­gy Today):

Recent­ly the U.S. Food and Drug Admin­is­tra­tion (FDA) grant­ed break­through device des­ig­na­tion to Wysa’s AI-based dig­i­tal men­tal health con­ver­sa­tion­al agent that deliv­ers cog­ni­tive behav­ioral ther­a­py (CBT) via a smart­phone to adults suf­fer­ing from depres­sion, anx­i­ety, and chron­ic mus­cu­loskele­tal pain…

Wysa’s admit­tance to the FDA Break­through Devices Pro­gram sig­ni­fies a giant leap for­ward for arti­fi­cial intel­li­gence in the men­tal health indus­try. Accord­ing to the FDA, the des­ig­na­tion was sup­port­ed by a clin­i­cal tri­al that “found Wysa to be more effec­tive than stan­dard ortho­pe­dic care and com­pa­ra­ble to in-per­son psy­cho­log­i­cal coun­sel­ing” … The study authors affil­i­at­ed with the Wash­ing­ton Uni­ver­si­ty in St Louis School of Med­i­cine in St Louis, Mis­souri, and the Uni­ver­si­ty of Wash­ing­ton in Seat­tle, Wash­ing­ton, wrote:

  • Patients who received a dig­i­tal men­tal health inter­ven­tion as part of ortho­pe­dic care report­ed greater two-month mean improve­ments in depres­sion, pain inter­fer­ence, and phys­i­cal func­tion than patients who received usu­al ortho­pe­dic care.
  • They also report­ed a greater mean improve­ment in phys­i­cal func­tion and com­pa­ra­ble improve­ments in depres­sion, anx­i­ety, and pain inter­fer­ence com­pared with ortho­pe­dic patients who received in-per­son psy­cho­log­i­cal counseling.

The Announcement:

Wysa Receives FDA Break­through Device Des­ig­na­tion for AI-led Men­tal Health Con­ver­sa­tion­al Agent (press release):

Wysa, a lead­ing arti­fi­cial intel­li­gence (AI) based dig­i­tal com­pan­ion for behav­ioral health, has announced that the U.S. Food and Drug Admin­is­tra­tion (FDA) has grant­ed Break­through Device Des­ig­na­tion for its AI-based dig­i­tal men­tal health con­ver­sa­tion­al agent for patients 18 years and old­er with a diag­no­sis of chron­ic mus­cu­loskele­tal pain (defined as pain last­ing longer than three months) and depres­sion and anxiety.

The device deliv­ers cog­ni­tive behav­ioral ther­a­py (CBT) via a smart­phone-based con­ver­sa­tion­al agent to reduce the symp­toms of depres­sion and anx­i­ety, reduce pain inter­fer­ence, and improve phys­i­cal function.

The des­ig­na­tion fol­lows an inde­pen­dent peer reviewed clin­i­cal tri­al, pub­lished in JMIR, that found Wysa to be effec­tive for man­ag­ing chron­ic pain and asso­ci­at­ed depres­sion and anx­i­ety, which was found to be more effec­tive than stan­dard ortho­pe­dic care, and com­pa­ra­ble to in-per­son psy­cho­log­i­cal counseling.

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