Medical Design Briefs - February 2025 - 16

Landmark FDA Clearance
May Accelerate Compelling
Digital Therapeutics
F
or the 565 million people worldwide
struggling with mental
health issues, and the billions
more who love and support them,
a recent decision made by the
Food and Drug Administration (FDA) offers
encouragement and hope. The
agency has cleared a novel new software
designed to be integrated directly
into, or used alongside, existing
media - video games, mobile
apps, and more - to treat mental
health conditions (see Figure 1).
The clearance marks a significant
step forward in the rapidly evolving
field of digital therapeutics
(DTx), bringing potentially
life-changing mental health treatments
directly to the place where
people already spend time -
with media.
What Is a Digital
Therapeutic (DTx)?
Digital therapeutics encompass
evidence-based software
programs designed to prevent,
manage, or treat medical
conditions (see Figure 2). While
they have been around for years,
the excitement of this new field
was long overshadowed by the numerous
hurdles and challenges in
bringing DTx devices to market,
gaining adoption, and driving
compliance. The DTx industry has
also suffered from excessive hype,
coupled with failure to meet expectations,
and a resulting lack of
funding and government support.
Fortunately, recent advancements
appear to have DTx poised to finally
live up to its promises.
The basic construct of DTx involves
a device for sensing patient
vitals and/or directing therapeutic
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Medical Design Briefs - February 2025

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Medical Design Briefs - February 2025 - COV1a
Medical Design Briefs - February 2025 - COV1b
Medical Design Briefs - February 2025 - COV1
Medical Design Briefs - February 2025 - COV2
Medical Design Briefs - February 2025 - 1
Medical Design Briefs - February 2025 - 2
Medical Design Briefs - February 2025 - 3
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Medical Design Briefs - February 2025 - 5
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Medical Design Briefs - February 2025 - COV3
Medical Design Briefs - February 2025 - COV4
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