Digital Health,
Journal Year:
2022,
Volume and Issue:
8, P. 205520762210890 - 205520762210890
Published: Jan. 1, 2022
Concerns
have
been
raised
over
the
quality
of
evidence
on
performance
medical
artificial
intelligence
devices,
including
devices
that
are
already
market
in
USA
and
Europe.
Recently,
Medical
Device
Regulation,
which
aims
to
set
high
standards
safety
quality,
has
become
applicable
European
Union.
The
aim
this
article
is
discuss
whether,
how,
Regulation
will
help
improve
entering
market.
introduces
new
rules
for
risk
classification
result
more
subjected
a
higher
degree
scrutiny
before
market;
stringent
requirements
clinical
evaluation,
requirement
appraisal
data;
post-market
surveillance,
may
spot
early
any
new,
unexpected
side
effects
risks
devices;
notified
bodies,
expertise
personnel
consideration
relevant
best
practice
documents.
guidance
Coordination
Group
evaluation
device
software
MEDDEV2.7
guideline
also
attend
some
problems
identified
studies
devices.
likely
impact
however,
dependent
its
adequate
enforcement
by
Union
member
states.
Insights into Imaging,
Journal Year:
2024,
Volume and Issue:
15(1)
Published: Feb. 5, 2024
Abstract
Objective
To
provide
a
comprehensive
framework
for
value
assessment
of
artificial
intelligence
(AI)
in
radiology.
Methods
This
paper
presents
the
RADAR
framework,
which
has
been
adapted
from
Fryback
and
Thornbury’s
imaging
efficacy
to
facilitate
valuation
radiology
AI
conception
local
implementation.
Local
newly
introduced
underscore
importance
appraising
an
technology
within
its
environment.
Furthermore,
is
illustrated
through
myriad
study
designs
that
help
assess
value.
Results
seven-level
hierarchy,
providing
radiologists,
researchers,
policymakers
with
structured
approach
AI.
designed
be
dynamic
meet
different
needs
throughout
AI’s
lifecycle.
Initial
phases
like
technical
diagnostic
(RADAR-1
RADAR-2)
are
assessed
pre-clinical
deployment
via
silico
clinical
trials
cross-sectional
studies.
Subsequent
stages,
spanning
thinking
patient
outcome
(RADAR-3
RADAR-5),
require
integration
explored
randomized
controlled
cohort
Cost-effectiveness
(RADAR-6)
takes
societal
perspective
on
financial
feasibility,
addressed
health-economic
evaluations.
The
final
level,
RADAR-7,
determines
how
prior
valuations
translate
locally,
evaluated
budget
impact
analysis,
multi-criteria
decision
analyses,
prospective
monitoring.
Conclusion
offers
valuing
Its
layered,
hierarchical
structure,
combined
focus
relevance,
aligns
seamlessly
principles
value-based
Critical
relevance
statement
advances
by
delineating
much-needed
valuation.
Keypoints
•
Radiology
lacks
assessment.
provides
dynamic,
method
thorough
bridging
implementation
gap.
Bioengineering,
Journal Year:
2024,
Volume and Issue:
11(5), P. 451 - 451
Published: May 2, 2024
Artificial
intelligence
(AI)
has
been
implemented
in
multiple
fields
of
medicine
to
assist
the
diagnosis
and
treatment
patients.
AI
implementation
radiology,
more
specifically
for
breast
imaging,
advanced
considerably.
Breast
cancer
is
one
most
important
causes
mortality
among
women,
there
increased
attention
towards
creating
efficacious
methods
detection
utilizing
improve
radiologist
accuracy
efficiency
meet
increasing
demand
our
can
be
applied
imaging
studies
image
quality,
increase
interpretation
accuracy,
time
cost
efficiency.
mammography,
ultrasound,
MRI
allows
improved
while
decreasing
intra-
interobserver
variability.
The
synergistic
effect
between
a
potential
patient
care
underserved
populations
with
intention
providing
quality
equitable
all.
Additionally,
allowed
risk
stratification.
Further,
application
have
implications
as
well
by
identifying
upstage
ductal
carcinoma
situ
(DCIS)
invasive
better
predicting
individualized
response
neoadjuvant
chemotherapy.
advancement
pre-operative
3-dimensional
models
viability
reconstructive
grafts.
Radiology,
Journal Year:
2025,
Volume and Issue:
314(2)
Published: Feb. 1, 2025
This
article
describes
the
status
and
potential
expansion
of
artificial
intelligence
in
thoracic
imaging,
including
practical
issues
for
its
clinical
implementation
into
daily
practice
as
well
challenges
opportunities.
Digital Health,
Journal Year:
2022,
Volume and Issue:
8, P. 205520762210890 - 205520762210890
Published: Jan. 1, 2022
Concerns
have
been
raised
over
the
quality
of
evidence
on
performance
medical
artificial
intelligence
devices,
including
devices
that
are
already
market
in
USA
and
Europe.
Recently,
Medical
Device
Regulation,
which
aims
to
set
high
standards
safety
quality,
has
become
applicable
European
Union.
The
aim
this
article
is
discuss
whether,
how,
Regulation
will
help
improve
entering
market.
introduces
new
rules
for
risk
classification
result
more
subjected
a
higher
degree
scrutiny
before
market;
stringent
requirements
clinical
evaluation,
requirement
appraisal
data;
post-market
surveillance,
may
spot
early
any
new,
unexpected
side
effects
risks
devices;
notified
bodies,
expertise
personnel
consideration
relevant
best
practice
documents.
guidance
Coordination
Group
evaluation
device
software
MEDDEV2.7
guideline
also
attend
some
problems
identified
studies
devices.
likely
impact
however,
dependent
its
adequate
enforcement
by
Union
member
states.
