FM DECEMBER 2018 ISSUE - digital edition

devices&gadgets
Shoulder
arthroplasty
system approved
S
houlder Innovations
received US FDA approval
for InSet Humeral Short Stem
System.
The clearance covers
products meant for partial or
total shoulder arthroplasty
used in the treatment of
degenerative, rheumatoid
or traumatic arthritis in the
shoulder.
The new InSet shoulder
system provides innovative
features and solutions to
address potential problems
encountered with current
total shoulder replacement
systems.
Leveraging its
breakthrough InSet glenoid
design, Shoulder Innovations
is commercialising a shoulder
replacement implant system
focused on improving
outcomes related to glenoid
loosening. This forms the
leading cause of shoulder
replacement failure.
The InSet technology
has been shown in testing
to significantly reduce
glenoid implant micromotion
and simplifies the
surgical technique, potentially
reducing complications or
increase implant longevity,
according to a company
release.
Device to treat urinary
incontinence gets nod
Atlantic Therapeutics said the US FDA
granted a DeNovo clearance for its
Innovo therapy device, an externally
worn electrical muscle stimulator for the
treatment of stress urinary incontinence in
adult females.
FDA cleared the transcutaneous
electrical stimulation continence device
following the results of two randomized
controlled trials demonstrating it to be
an effective and low-risk device for the
treatment for stress urinary incontinence in
adult females.
The data from its pivotal US trial
showed 87.2% of patients were dry or
mild after a 12-week treatment period,
with 93% of patients experiencing
improvement in just 4 weeks.
This follows the presentation of data
from an earlier placebo-controlled trial
conducted in Europe that demonstrated
significant improvement across all study
endpoints.
Innovo’s Multipath technology
uses electrical muscle stimulation to
deliver 180 perfect and complete pelvic
floor contractions to the entire network of
pelvic floor muscles in every
30-minute session. It is designed
to optimally
strengthen the
pelvic floor and
re-educate the
muscles that
control bladder
function.
EAP for AI tech
to detect
haemorrhage
software medical
A device for intracranial
haemorrhage detection has
been granted the Expedited
Access Pathway (EAP)
designation by the USFDA.
The device, based on
deep learning technologies,
automatically analyses
noncontrast head CT images.
It is designed to be highly
sensitive to the presence of
intracranial haemorrhage
(ICH) in these scans and to
alert the treating physician
78 / FUTURE MEDICINE / DECEMBER 2018