FDA clears DeepWell SDK to be used in games for stress reduction

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Mental
health-focused
studio
DeepWell
has
received
clearance
from
the
US’
Food
and
Drug
Administration
for
its
biofeedback
SDK
to
be
used
therapeutically
to
help
with
stress
reduction
and
high
blood
pressure.

This
means
DeepWell
will
be
able
to
make
the
SDK
available
to
other
firms
who
might
want
to
use
it,
with
the
end
goal
to
“accelerate
the
commercialisation
of
video
games
and
other
immersive
media
as
FDA-cleared
digital
therapeutics,”
the
announcement
said.

It
clarified
that
any
media
incorporating
DeepWell
technology
will
be
available
without
needing
a
prescription.

DeepWell’s
SDK
is
described
as
providing
“biostimulation
in
interactive
media
that
activates
the
user’s
vagus
nerve
while
greatly
increasing
patient
engagement,
reducing
sympathetic
nervous
system
activation,
and
releasing
dopamine
for
coping
that
improves
resilience
to
reduce
stress
and
hypertension.”

When
asked
for
more
details
and
clarification
about
what
it
means
and
about
the
practical
applications,
a
spokesperson
for
the
company
told

GamesIndustry.biz

that
the
SDK
can
be
implemented
primarily
in
three
ways,
and
took
the
integration
of
a
breathing
mechanic
as
an
example
(DeepWell
previously
released
a
VR
game
called
Zengeance
where
players
had
to
breathe
audibly
as
part
of
the
main
gameplay
mechanic).

One
option
is
to
have
said
breathing
mechanic
be
incorporated
directly
as
part
of
a
title’s
gameplay,
with
the
spokesperson
explaining:
“For
example,
in
a
sports
game
players
could
hold
a
vocal
hum
to
accurately
fill
a
metre
to
get
the
perfect
swing.
Or
the
player
could
enter
a
‘sharpshooter’
game
where
they
must
relax
and
control
their
breathing
to
eliminate
camera
movement
and
increase
their
accuracy.”

The
second
option
is
to
have
it
be
“adjacent
to
the
media,”
the
firm
said,
explaining:
“For
example,
in
a
Zelda
game
you
could
enter
a
special
temple
that
enhances
your
player
abilities
for
completing
a
breathing
challenge.”

Finally,
the
breathing
mechanic
can
be
“added
to
a
platform
of
organised
content,”
with
the
example
given
being
a
distinct
‘Mental
health’
tab
on
Netflix
or
the
App
Store
that
“shows
specifically
recommended
games/apps/shows/movies
for
mental
health,
with
a
recommendation
to
try
a
game
or
media
that
has
the
breathing
mechanic
enabled.”

It’s
unclear
exactly
how
that
differs
from
existing
mental
health-focused
apps
that
offer
breathing
exercises,
or
what
other
applications
are
possible.

Co-founder
of
DeepWell
and
paediatric
neurosurgeon
Dr.
Samuel
Browd
explained
as
part
of
the
announcement
that
only
20
out
of
350,000
digital
wellness
products
have
been
FDA
cleared,
“including
just
five
for
mental
health
and
only
one
SDK”
(which
is
DeepWell’s).

Co-founder
and
chairman
Ryan
Douglas
further
explained:
“Our
technology
could
be
used
in
future
digital
treatments
for
pain,
PTSD,
epilepsy,
sleep
disorders,
immune
disorders,
Parkinsons,
Alzheimer’s,
and
as
a
critical
connection
point
for
brain
computer
interfacing.”


DeepWell
was
founded
in
March
2022
,
originally
the
brainchild
of
Douglas
and
of
Devolver
Digital
co-founder
Mike
Wilson.
The
latter
announced
last
May
that

he
departed
the
firm
in
late
2023

“along
with
almost
all
of
the
games
industry
colleagues
[he]
brought
to
that
company.”

He
explained:
“[I]
have
absolutely
nothing
to
do
with
the
game
they
released
on
the
Quest
store
(which
they
called
Zengeance)
and
which
my
colleagues
also
asked
to
have
their
names
removed
from.
I
still
have
high
hopes
and
strong
beliefs
for
the
power
of
games
and
other
digital
media
to
benefit
people,
but
could
not
see
a
path
to
getting
it
done
in
that
company.”

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