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Printable Handouts
Navigable Slide Index
- Introduction
- Contents
- Medical devices
- Digital Health Technologies (DHTs)
- What are Digital Therapeutics (DTx)?
- Examples of DTx
- DTx can address various medical needs
- Potential benefits of DTx
- Comparing development: DTx and drugs/biologics
- Drugs/biologics vs. DTx
- Drug-DTx combinations may be developed
- DTx: regulatory pathways (USA FDA | CDRH)
- DTx: multi-stakeholder perspective
- DTx can potentially address health disparities
- A recent example of DTx added value
- Summary
- Thank you!
Topics Covered
- Digital Therapeutics (DTx)
- Technology and medical devices
- Digital health technologies
- Comparison of digital therapeutics and drugs/biologics
- Drug-DTx combinations
- Digital therapeutics and COVID-19
Links
Categories:
External Links
- US FDA: What is Digital Health?
- Digital Therapeutics Allicance. Digital Health, Digital Medicine, Digital Therapeutics (DTx): What’s the difference?
- Digital Therapeutics: Definition and Core Principles
- US FDA: Digital Health Center of Excellence
- Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19)
Talk Citation
Sverdlov, A. (2025, January 30). Introduction to digital therapeutics [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved February 12, 2025, from https://doi.org/10.69645/JFBB2228.Export Citation (RIS)
Publication History
Financial Disclosures
- Oleksandr Sverdlov is an employee and holds stock at Novartis.
A selection of talks on Clinical Practice
Transcript
Please wait while the transcript is being prepared...
0:00
Hello, everyone!
My name is Alex Sverdlov,
I'm a Senior Director of
Biostatistics at Novartis.
Today, I'm going to give
a brief introduction to
the field of digital
therapeutics.
0:16
Here is the outline of my talk.
I'll start with an overview of
digital health technologies and
their importance in
modern healthcare.
I will go over some
defining features of
digital therapeutics and
provide some examples.
Then, I will speak to
the importance and
the need for building
the evidence base for
digital therapeutics,
and the potential added value of
these products in practice.
Finally, I will
give a summary and
the future perspective
on digital therapeutics.
0:51
The idea of using technology to
provide life support and
treatment is not new.
Medical device systems of
various complexity have
become ubiquitous.
One can give
multiple examples of
medical devices in
different areas.
For instance,
the cardiac pacemaker is
a remarkable invention with
about a 300-year history,
that has been a
critical driver of
many developments in cardiac
science and medicine.
Its development started with
the experiments in
electrophysiology in
the 18th century.
With the creation of initial
machines in the 1920s and
external stimulators designed
and built in the 1950s.
It was miniaturized
and transitioned to
microprocessor-controlled
implantable pacemakers in the 1990s,
and it continued development
in the early 21st century.
As another example,
let us consider the
success stories of
various artificial organs
such as artificial kidneys.
Hemodialysis as a means of
replacing renal function,
started in the 20th century and
these tools evolved from
capillary dialyzers and sorbent
systems in the 1960s to
wearable artificial
kidney systems.
A recent U.S. FDA clearance of
the Artificial Kidney 98
Dialysis Machine highlights
a significant milestone in
bringing new improved
quality of care for
many patients who
are on hemodialysis.