AllotropeMedical, a Houston based medical startup has devised StimSite, a novel, hand-held,
single use device that precisely identifies ureter during surgery; thus,
eliminating the need for ureteral stenting.
It is specifically useful in all gynecological,
colorectal and oncosurgeries. Gynecological surgery accounts for 50% of all iatrogenic
ureteric injuries
It is estimated that around 3 million
surgeries performed in US annually, require an identification of ureter. The
rate of ureteric injuries is around 2% with disastrous consequences and the
total healthcare burden of this complication is about $3.2B every year.
It is also estimated that about 30% surgical
time is spent on identifying the ureter.
The surgeon can simply place the tip
of the device in the vicinity of the ureter and with a push of a button, the
ureter goes into contraction and the full length of ureter towards kidney and
bladder can be identified.
There is no other smooth muscle
structure in that anatomical region, so the device specifically identifies
ureter only.
The device is single use, battery
operated and avoids additional procedures like cystoscopy on the operation
table.
Allotrope aims to initially market the
device for two high volume procedures, Hyterectomy (750,000 in US) and colon resection
(300,000 cases). The current alpha prototype is a hand held, stand alone device
that can be used in both open and minimal invasive surgeries. The company plans
to enter the Robotic market in future by designing device for their platforms.
Currently, StemSite is at pre-FDA state,
but plans to get FDA clearance through the 510(k) pathway, and entering the
marketplace by first quarter of 2019.
Allotrope has recently won second
place in MedTech Innovator’s 2017 competition, among 600 startups.
Here is a video by Allotrope showing the
functioning of the device.
We are one step closer to the goal of
repairing dead heart muscle in human beings, because of a research breakthrough
by biomedical engineers at Duke
University. The researchers have succeeded in creating a fully functioning
artificial human heart muscle large enough to patch the area typically seen in
patients who have suffered a heart attack.
The study was published on line in Nature
Communications on November 28, 2017.
Ilia Shadrin, a biomedical engineering
doctoral student at Duke University and first author on the study said in a newsletter,
"Right now, virtually all existing therapies are aimed at reducing the
symptoms from the damage that's already been done to the heart, but no
approaches have been able to replace the muscle that's lost, because once it's
dead, it does not grow back on its own. This is a way that we could replace
lost muscle with tissue made outside the body."
It is estimated that around 12 million
people worldwide suffer for myocardial infarction and continue living with the
damaged tissue that could not contract or send electrical signals, both of
which are necessary for proper heart function.
The heart patch is grown from human pluripotent
stem cells and contains a myriad of different type of cells like cardiomyocytes,
fibroblasts, and endothelial and smooth muscle cells, to create a tissue
patch similar to functioning heart muscle. The patch can secrete enzymes and
growth hormone that could help in recovering from the ischemic damage.
All these cells are put in specific
combination in a jelly-like substance, where they reorganize and grow into
functioning tissue. Each individual tissue patch has to be ‘custom made’ in
separate container that needs a rocking and swaying motion, instead of being
static.
Currently, these patches have been
successfully implanted into animal hearts. The researchers have to make many modifications
to create the same tissue for human heart like increasing the thickness and vascularization.
Here is the video by Duke University showing
the patch contracting on its own, a 3D visualization of the patch’s cells, and
the rocking bath that proved critical to the heart patch’s record-breaking
size.
Artificial intelligence (AI) has become a permanent fixture in medical
practice and if you are attending a recent conference, you will see or hear the
words like deep learning, machine learning or artificial neural networks everywhere.
It is going to forever change how physicians work and will help in
increasing workflow efficiency, improve diagnosis by new algorithm and totally
change the way the patients and physicians interact.
AI is particularly useful in field of radiology, as it can scan thousands
of X-rays or images in minutes, compare it with old reports and will act as a
second set of eyes to confirm the physicians's diagnosis and not replace physicians as feared.
Adam Flanders, M.D., co-director, neuroradiology and vice-chair of
informatics at Jefferson University Hospitals, Philadelphia, and chair of the
RSNA Radiology Informatics Committee, discusses the impact of AI at Radiological Society of North America annual meeting( RSNA) 2017.
With a wide
array of features like GPS, depth perception and many health-related features
like BP and ECG monitoring, Smartphones have become indispensable part of our
daily lives. They are the health gadgets of future. But, so far nothing was
much developed for diabetics, other than the use of phone screen to display results of continuous glucose monitoring on the screen.
Engineers at
the University of California San Diego have cleverly integrated a glucose
monitor in the smartphone case and app, that will enable diabetic patients to
record and track their blood glucose readings, whether they’re at home or on
the go.
Currently, there
is no way for people with diabetes to check the blood glucose when they are out
of the house or travelling. They must pack the whole kit and carry it along
with them.
Patrick
Mercier, a professor of electrical and computer engineering at UC San Diego is
the brain behind this new gadget. “Integrating blood glucose sensing into a
smartphone would eliminate the need for patients to carry a separate device,”
said Patrick Mercier, he said in a news release. “An added benefit is the
ability to autonomously store, process and send blood glucose readings from the
phone to a care provider or cloud service.”
The new
device is named GPhone, and has two main parts. A slim, aesthetically designed,
3D printed case that fits over the smartphone with a permanent, reusable sensor
at the top left corner.
The sensor
has to be activated by one-time use enzyme packed pellets that magnetically
attach to the sensor.
To run a
test, a user has to activate the sensor by dispensing a pellet on it, followed by
adding a drop of blood to the now activated sensor. The sensor measures the
glucose concentration and wireless send it via a Bluetooth to a custom designed
android app, that displays the results on the screen.
The user can
communicate the results with his healthcare provider or store it in icloud, to
track it over a long period of time.
The pellet is
discarded after use and the sensor is deactivated. A 3D printed stylus with
capacity of 30 pellets store them, and remains attached to the side of the
case.
The pellet
contains enzyme called glucose oxidase which reacts with glucose and generates
an electrical signal in proportion to glucose levels that is picked by the
sensor’s electrode.
The work is
currently at proof of concept stage. Joseph Wang, nanoengineering
professor and his other colleagues dream of integrating the monitor with the
smartphone instead of case. They are also working currently to reduce the amount
of blood needed for testing and bringing down the cost of the pellets, which
are costlier than usual test strips.
Researchers
from Duke University and Stanford University have designed a $10 microchip to
make a simple 3D ultrasound imaging device that produces 3D scans similar in
quality to CT or MRI scans using your regular 2D ultrasound machine.
The
researchers and physicians from Duke demonstrated their device on Oct. 31 at
the American College of Emergency Physicians (ACEP) Research Forum in
Washington, D.C.
The budget
microchip is roughly the size of a fingernail, and like a Nintendo Wii video
game controller, the chip registers the probe’s orientation, then uses software
to seamlessly stitch hundreds of individual slices of the anatomy together in
three dimensions to give an instant 3-D
model similar in quality to a CT scan or MRI. And the better the ultrasound machine
being used, the higher the quality of the generated 3D image.
The chip can be added to your regular
2D ultrasound armament by using a 3D printed clip on attachment. 3D ultrasound machines can cost
around $250,000, around five times more than their 2D counterparts.
Joshua Broder,
M.D., an emergency physician and associate professor of surgery at Duke
Health and one of the creators of the technology got the idea behind the chip
while playing Nintendo games with his son
After working on the chip for a year, he took
sketches to Duke’s Pratt School of Engineering, connecting with
then-undergraduate Matt Morgan, and biomedical engineering instructors and
professors Carl Herickhoff and Jeremy Dahl, who have since taken positions at
Stanford where they continue to develop the device.
The team has used Duke’s own 3-D
printing labs to create a prototype, in the form of a streamlined plastic
holster that slips onto the ultrasound probe. A physician can use the probe as a
regular 2D probe or add the 3-D capability by simply snapping on a plastic
attachment containing the location-sensing microchip. To get the best 3-D
images, the team also devised a plastic stand to help steady the probe as the
user hones in on one part of the anatomy.
The microchip and the ultrasound probe
connect via computer cables to a laptop programmed for the device. As the user
scans, the computer program whips up a 3-D model in seconds.
Both Duke and Stanford are testing the
technology in clinical trials to determine how it fits in the flow of patient
care. The creators believe some of the most promising uses could be when CT
scans or MRIs are not available, in rural or developing areas, or when they are
too risky.
“Instead of looking through a keyhole
to understand what’s in the room, we can open a door and see everything in
front of us.”
This upgrade is especially important
for babies and trauma patients who cannot be moved. The team has already
received a grant from Emergency Medicine Foundation and General Electric to
conduct clinical trials for application of the device to located bleeding vessels
in trauma patients.
The quality of resulting 3D model is comparable
to images produced by a 3D sonography machine, CT scan or MRI scan.”
Clinical trials are already on the way
to test the technology in real life applications and emergency scenarios.
Here is a video in which Dr.Broder demonstrate
the device .
Apple announced
the launch of its previously stated Heart Study with the release of the Heart
Study app. The Apple Heart Study app is an innovative research study that uses
data from Apple Watch to identify irregular heart rhythms, including those from
potentially serious heart conditions such as atrial fibrillation (AFib). This
study is being conducted in collaboration with Stanford Medicine to accelerate
discovery in heart science.
Anyone who
is 22 years or older, resident of US and owns an apple watch series 1 or newer
can download the app. As a part of study, the app will collect data throughout
the day, and monitor your heart rate and rhythm. It notifies you on your iPhone and apple watch, if an
irregularity is detected .
After
the notification, you’ll receive a free video consultation on your iPhone with
the study’s medical professionals for further analysis. - The video
consultation connects you with a board-certified, licensed primary care
provider- 24 hours a day, 7 days a week.
In some
cases, you will also receive a BioTelemetry electrocardiogram (ECG) patch for
additional monitoring. The patch is mailed to study participants at no cost,
and required to be worn for 7 days. The data will be analyzed to see if patient
is suffering from Afib or other problems of irregular rhythm.
“Through the
Apple Heart Study, Stanford Medicine faculty will explore how technology like
Apple Watch’s heart rate sensor can help usher in a new era of proactive health
care central to our Precision Health approach,” said Lloyd Minor, Dean of
Stanford University School of Medicine. “We’re excited to work with Apple on
this breakthrough heart study.”
To monitor
and calculate the rate and rhythm,Apple Watch’s sensor uses LED lights flashing hundreds of times per
second and light-sensitive photodiodes to detect the amount of blood flowing
through the wrist as an indicator of the heart’s activity. The data gathered
along with Apple’s powerful software algorithms identifies an irregular heart
rhythm.
This method
which is also used in other wearables, is considered less sensitive than ECG
sensors. So, the ability of Apple watch to detect arrhythmias would be a giant
leap in wearables market.
Recently,
AlivCor has launched FDA approved KardiaBand, a single-lead ECG device for the
Apple Watch.
AliveCor announced FDA clearance of the KardiaBand single-lead ECG device
for the Apple Watch. AliveCor are the pioneers in field of personal EKG
technology. It’s now easy to keep a watch on your heart simply by wearing this
device around your wrist. Pairing with the expertise and artificial intelligence
of Apple Watch, Kardiaband can detect sinus heart rhythm and atrial
fibrillation(Afib) discreetly in just 30 seconds by simply a touch of the
button.
KardiaBand is a self-contained, FDA-cleared, miniaturized ECG device.
The results
are displayed on the apple watch. The Kardia app pairs with SmartRhythm, a new
feature within the Kardia app, and receives continuous inputs about the heart
rate, rhythm and physical activity from Apple Watch's activity sensors. Using a FDA-cleared analysis algorithm, it
can sense if something is not normal and notifies the user to capture an EKG. The Kardia’s ECG analysis algorithm also
identifies if the ECG is normal or not. The captured EKG can be mailed to a healthcare provider.
The diagnostic
yield is at par to a 14-day ambulatory event monitor and Holter monitor.
Physicians
can use KardiaBand for arrhythmia assessment,
managing patients with AFib, diagnosing AFib early in high risk patients and patient
management of cardiac risk factors.
"KardiaBand
paired with SmartRhythm technology will be life-changing for people who are
serious about heart health," said Vic Gundotra, CEO, AliveCor.
"These capabilities will allow people to easily and discreetly check their
heart rhythms when they may be abnormal, capturing essential information to
help doctors identify the issue and inform a clear path of care to help manage
AFib, a leading cause of stroke, and other serious conditions."
AFib affects
nearly 30 million people round the globe, with 1 in 4 people more than 40 years
at risk of developing it. It is leading cause of stroke and 2 out of 3 strokes
are preventable if detected and managed on time.
Dr. Ronald
P. Karlsberg, MD FACC, Board Certified Cardiologist and Clinical Professor of
Medicine, Cedars Sinai Heart Institute and David Geffen School of
Medicine UCLA said, "This is a paradigm shift for cardiac care as well as
an important advance in healthcare."
"Today,
EKGs are available only in offices and hospitals, using complex equipment, and
usually only after a life-threatening event, for example a stroke. With an EKG
device on the wrist, AFib can be detected wherever the patient is, 24 hours a
day. In randomized research trials, KardiaMobile, the first AliveCor EKG
device, proved to be superior to routine care provided by physicians. Today,
KardiaBand is a giant leap in personalized health care," he added.
People all
around the world would be benefitted by AliveCor, because it provides peace of
mind by providing important diagnostic tool and communication between the
patient and cardiologist.
The device
runs on an internal lithium battery with a lifetime of 1-2 years, the sensor in
KardiaBand is always ready to use - with the recording screen open on your Apple
Watch, simply touch your index finger to the KardiaBand sensor to start a
recording.
KardiaBand
is available starting today for $199 and requires subscription to
AliveCor's Premium service for $99 a year. The combined system
includes SmartRhythm notifications on Apple Watch; unlimited EKG recordings;
automatic detection of Atrial Fibrillation or normal sinus rhythm; the
unlimited ability to send EKG readings to anyone via email; unlimited cloud
history and reporting of all EKGs ever taken; weight and medication tracking;
and a mailed monthly paper report on readings taken each calendar month.
If you do
not have Apple Watch, you can still use Kardia to record EKG on your mobile. The
basic service and Kardia app for mobile costs $99 as compared to KardiaBand
which costs $199.
Hologic Inc.
announced it has received 510(k) clearance from the U.S. Food and Drug
Administration (FDA) for its Quantra 2.2 Breast Density Assessment Software.
The software helps radiologists and clinicians to provide information about
breast density to women during routine breast cancer screenings.
Quantra standardizes
breast density reporting and helps eliminates the visual subjectivity by
radiologists, through a proprietary algorithm powered by machine learning. The
software classifies the breast tissue into four density categories based on ACR Breast Imaging Reporting and Data System( ACRBI-RADS®) Atlas 5th Edition, based on the distribution of
fibroglandular tissue and texture of breast
tissue.
The BI-RADS®
Atlas provides standardized breast imaging findings terminology, report
organization, assessment structure and a classification system for mammography,
ultrasound and MRI of the breast.
The Quantra
software is compatible with Hologic's 3D Mammography systems, including the new
3Dimensions mammography system, which is designed to be the fastest, highest
resolution breast tomosynthesis system ever, with the 'Intelligent 2D imaging
technology'.
Nearly 40%
of women between the age of 40 and 74 have dense breasts, which can make it
difficult to detect breast cancer during annual screenings and necessitates additional
imaging, resulting in increased patient anxiety and unnecessary facility costs.
Perhaps most importantly, women with very dense breasts are four to five times
more likely to develop breast cancer than women with less dense breasts.
The software
is one of several groundbreaking products that is available for demonstration
in Hologic's booth (#4705) at the ongoing 103rd Scientific
Assembly and Annual Meeting of the Radiological Society of North America (RSNA)
at McCormick Place in Chicago from Nov. 26 to 30.
Pete Valenti,
Hologic's Division President, Breast and Skeletal Health Solutions said, "As
the global leader in breast cancer screening technology, we relentlessly pursue
the development of clinically superior products that address the unmet and
changing needs of our customers and their patients, especially when it comes to
breast density. Quantra software is yet another example of our dedication and
we are proud to feature it – along with a number of other new, breakthrough
products – for the world's leading radiologists at RSNA this week."
Earlier this
year, FDA approved its Genius 3D Tomosynthesis Mammography as the only test
superior to 2D mammography for routine breast cancer screening for women with
dense breasts.
Hologic also commercially launched its Smart Curve breast stabilization system at the same time, that makes mammography experience less
painful for women without compromising on image quality and diagnostic
accuracy.
Hologic
Worldwide Quantra Volumetric Breast Density Assessment
A Robot
named Xiaoyi have cleared China’s medical licensing examination in August of
this year, reported south China morning post. The robot is aptly named Xiaoyi which means ‘little
doctor’ and completed the test in fraction of time as compared to his human competitors.
In practice
run, Xiaoyi could only score 100/600 and the passing score is minimum of 360.
Disappointed
by the practice test score, Xiaoyi decided to study hard and was trained to absorb
the contents of dozens of medical textbooks, 2 million medical records, and
400,000 articles to develop the kind of reasoning needed to be a doctor, The
Beijing News reported on the weekend.
It passed
the test with a score of 456.
The first
robot to ever pass a medical licensing examination is developed by iFlyTek, in
coordination with Tsinghua University.
The robot
was able to identify words, link between words and sentences to develop a capacity
to reason, but did not do well in question pertaining to patients’ cases.
So, the
healthcare industry can be rest assured that Xiaoyi will actually not replace
physicians and health care providers in current setting. But, it can certainly
be useful in assisting physicians to interpret the signs and symptoms faster
and making suggestions.
The robot
will officially be launched in March 2018 and the company vision is, it can
help patients in remote Chinese villages, which are always short of primary
care physicians.
China has
already opened the world’s first artificial intelligence based treatment
center.
3-D printing
technology allows you to print in three dimensions, instead of usual two. It is
emerging technology that has many lives saving applications in medical field
and its full potential is yet to be utilized by the physicians and researchers.
It is called bioprinting when it is used in medical arena to print body parts.
You can
print body parts made up of gamut of materials from powdered titanium alloy,
plaster, ceramic and glass to thermoplastic and even photopolymers. The body
parts can be grasped in hands.
It has some
special applications in cardiology, and can be divided into 3 categories. It
allows for printing models of babies with congenital heart diseases, so that
the surgeon is trained before the actual procedure and knows instantly what
operation is to be performed. Customized heart parts that are very near to the
natural body parts can be printed so that replacement surgeries are easy and functional.
It has a huge potential in the field of adult structural heart defects. The
third category is a distant ‘moonshot’-the 3D fabrication of an entire,
implantable replacement heart.
The actual
technology is nearly 30 years old, but has made its way in the medical field
since last 10 years.
Imaging of
the heart model primarily by computed tomography (CT) and magnetic resonance
imaging is the first step in printing the heart. A 3-D modelling program then
makes a digital file in a computer-aided design (CAD) file. The digital file is
then uploaded to a 3-D printer along with the appropriate raw material and the
object is created layer by layer.
In this
video Dee Dee Wang, M.D., Director, Structural Heart Imaging at Henry Ford
Hospital, Detroit, explains how her center uses 3-D printing and computer aided
design (CAD) software to improve patient outcomes.
Cianna
Medical, Inc. has received FDA clearance of the SAVI SCOUT® reflector for long
term use. The SAVI SCOUT reflector is an integral part of the SAVI SCOUT®
surgical guidance system, a novel wire free technology that uses real-time
audible and visual indicators for precise localization of tumor during
lumpectomy and excisional biopsy procedures.
This
technology is the first and only
non-radioactive implant, that uses electromagnetic wave technology,
with no restrictions on the length of time the reflector can remain in the
breast.
This will
enable the surgeons to precisely target the affected tissue using the
system’s capability of 360˚ detection and ability to pinpoint tumor location down
to ±1mm, this conserves breast tissue and is more aesthetic for women at the
same time increasing the surgical precision and reducing the need for repeat
surgery.
In addition,
a woman with in situ SCOUT reflector can easily undergo MRI, as it does not
interfere with the study.
The SCOUT
reflector is 4 mm in size, and remains completely passive till it is activated by
a handheld radar system. As the radar system is placed against breast, the
Scout system starts sending audio-visual cues for the precise position of the reflector.
It also
eliminates the need of same day surgery and can remain in place between the
time of biopsy to surgery.
Before the
clearance the reflector was only allowed to stay in place for 30 days, now the
time limit has been removed.
The device
received its initial clearance in 2014, based on a result of small pilot study
of 50 patients published later in June 2016 in the Annals of Surgical Oncology.
A larger subsequent
study also by Cox et al. was published in Annals of Surgical Oncologyinvolved 154 patients and the researchers
concluded that, “SCOUT provides a reliable and effective alternative method for
the localization and surgical excision of nonpalpable breast lesions using no
wires or radioactive materials, with excellent patient, radiologist, and
surgeon acceptance.”
Dr. Alice
Police was the first surgeon in the country to adopt SCOUT in late
2015, at UC
Irvine Medical Center, in Orange County, CA. “My focus is
always on finding a better breast cancer operation,” Dr. Police said.
“SCOUT is the standard of care for my breast localizations as I
utilize this wire-free approach for all scenarios requiring localization.
The distance feature provides more control over the procedure which is
important for predictable outcomes.”
Cianna
Medical requires that each site and physician using SCOUT Radar Localization successfully
complete training prior to initial cases.
Soon sutures
and staples are the current options for closing the skin, but a unique wound
closure device is in the market called microMend, developed by a Seattle-based
medical device company-KitoTech Medical.
The product is
a unique combination of butterfly shaped bandage and staples. The device is
made up of material similar to bandage, but has two arrays of tiny
“microstaples” on either side of the ‘wing’.
The device is flexible and combines
the strength of staples with easy application of a bandage, closing the wound
three times faster.
The even
distribution of staples results in less scarring and inflammation, and provides
an effective barrier against skin infection. No additional dressing is required
to close the wound It’s tensile strength lasts as long as it takes for the
wound to heal.
The removal
is painless, and it could be removed at home by patient himself when instructed
by a healthcare personnel.
microMend finds
initial applications in cosmetic and plastic surgeries, but it is also useful in
emergency settings, minimal invasive surgery, laparoscopic surgeries, vascular and
spinal surgeries.
KitoTech
Medical, recently introduced microMend at the recent Annual Meeting of the
American Society for Dermatologic Surgery (Oct 5 - 7). The company has
conducted initial studies with dermatologists and plastic surgeons, but more
studies with other surgical specialties are on the way.
The product
is a brain child of Dr. Ron Berenson, a biotech and medical device entrepreneur,
who got inspiration for this idea by the work of Dr. Marco Rolandi, a professor
at the University of Washington. He was working on the use of tiny chitosan
microneedles to heal wounds.
Dr. Ron
Berenson is hopeful that the product use will extend to many more specialties will
become a major player in the industry of wound closure products.
He says, “Its
simplicity is deceptive. In fact, the design and development process took
years.”
