Invu by Nuvo™
User Manual
Appendices
NV-UMLS-0012
97
Appendix B.
Benefit Summary
ID
Benefit
Magnitude
of Benefit
Rationale
1
Remote pregnancy
monitoring
High
a significant improvement over the existing standard
of care, with many immediate and critical benefits,
such as the ability to monitor women in remote/rural
areas, women with COVID, etc
2
improved
Uterine activity
sensitivity
Medium
Higher sensitivity than the current standard of care
increases the chance of capturing a contraction,
which in turn, increase the chance of accurately
identifying a late deceleration, the identification of
which is based on the temporal relation between the
contraction and the deceleration. However, in the
antepartum setting with the current standard of care,
uterine activity is viewed as less critical for fetal
monitoring than the fetal heart rate. Thus the benefit
is classified as ‘medium’. [I don’t want to put too
much weight on the MUA as we will likely need to
reduce sensitivity in some form in the future]
3
Improved signal
separation
High
this is a known problem with the current standard of
care, which can lead to hazardous results. Thus,
resolving this problem has significant benefits
4
Passive sensing
Low
the dangers associated with the active sensing
technologies of the current standard of care (namely
doppler) have not been clearly demonstrated in
humans, but only in animals. Thus the benefit is
classified as ‘low’
5
Device sensitivity is not
impacted by high BMI
High
the limitation of the current standard of care in high
BMI is a known problem, which in some cases can
lead to the utilization of invasive methods (see
references). Thus, resolving this issue has significant
benefits
6
No reposition Necessary
Medium
Having a device which allows for true self
administration is an essential ability in a remote
system. While this benefit is important, a remote
system can still function without it. Thus the benefit
is classified as ‘medium’
7
Patient Management
Medium
having full control by the physician over the tests
being performed, and having all the information is an
important and necessary ability in a remote system.