Medical Device Monday: Artificial Intelligence to Detect Vision Loss in Diabetic Adults

Today’s science and technology is truly beginning to look like a SciFi movie: robots and medical devices with artificial intelligence performing tests and tasks to help make new discoveries and form conclusions that we might not be able to. We— as humans— can only do so much, but with the help of new, smarter medical devices, we can make more discoveries, improve diagnoses, and enhance a patient's quality of life. Artificial intelligence (AI) is a technology that uses algorithms and software to interpret complex data without human help, and is something that has definitely been on the medical horizon for a while. Thanks to the Breakthrough Devices Pathway (defined in a Wednesday Wisdom earlier this month), a new medical device has just been granted by the FDA that will help millions of patients.

IDx-DR is a device recently granted via the de novo pathway, and is geared towards adults with diabetes who run the risk of vision loss. There are more than 30 million adults living with diabetes in the US today, and one of the risks that comes with diabetes is vision loss, or diabetic retinopathy. Diabetic retinopathy is the most common cause of vision loss among adults with diabetes, and occurs when high blood sugar levels lead to swelling and leakage of blood vessels in the retina. There are two stages of diabetic retinopathy: the initial stage is called the Non-Proliferative Diabetic Retinopathy (NPDR) and the advanced stage is called the Proliferative Diabetic Retinopathy (PDR) which can lead to blindness. In NPDR, the tiny blood vessels weaken and can leak blood and fluid into the retina. Sometimes the blood vessels close and blood cannot reach the macula; these events lead to a blurry vision. In PDR, damaged vessels eventually close off leading to the growth of new, abnormal blood vessels in the retina. These new blood vessels can also be leaky...leading to an imbalance of the normal flow of fluid out of the eye...leading to pressure build up and eventual optic nerve damage. Additionally, the scar tissue stimulated by the growth of new blood vessels may lead to retinal detachment. IDx-DR is the first medical device to use artificial intelligence to detect higher levels of retinopathy in diabetic adults, and is a medical device developed to discover and detect these indicators to prevent vision loss.

Early detection of diabetic retinopathy is very critical in preventing vision loss, and this new medical device is one that works to make early detection more common, ultimately cutting down the percentage of diabetic adults that lose vision from diabetic retinopathy. The current mode of diagnosis involves a visit to the ophthalmologist who will either do a fluorescein angiography— where a yellow dye is injected to see what is happening with the retina— or an Optical Coherence Tomography (OCT) to measure the thickness of the retina.

Compared to these modes of diagnosis, IDx-DR promises to provide an immediate, reliable assessment for diabetic retinopathy which can be used even at a primary care physician’s office. One of the great things about it is you don’t have to be a rocket scientist to use it! It is designed to be user-friendly, and can be administered by trained novice operators who have no prior experience with ocular imaging.

Don’t believe me? Let’s figure out how this thing actually works...

Using a Topcon NW400 camera, the operator captures images of the retina. The retinal images are then uploaded onto a computer where the IDx-DR software is installed. The IDx-DR software then analyzes retinal images using algorithm to detect signs of retinopathy.  In less than a minute, the operator will receive a results report with one of the three outputs:

a.       Exam quality is insufficient if the images are of low quality

b.      Negative for more than mild diabetic retinopathy. Retest in 12 months.

c.       More than mild diabetic retinopathy detected. Refer to an eye care professional.

In a 2017 clinical study, IDx-DR was tested on 900 diabetic patients across 10 sites in the US. IDx-DR was successful in detecting mild diabetic retinopathy with 87% sensitivity and 90% specificity. That’s pretty awesome! Unfortunately, IDx-DR cannot be used on patients who already have vision loss, blurred vision, or floaters. It is also contraindicated in patients diagnosed with other eye issues, like macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion. Finally, IDx-DR can be used to only detect diabetic retinopathy and not any other ophthalmic diseases.

With an estimated 24,000 people who go blind from diabetic retinopathy each year due to lack of screening, IDx-DR promises to be a novel device in managing diabetic retinopathy. The benefit of this device far outweighs the risk and we're excited to see it come to market!  

Image from https://www.retinamd.com/

Image from https://www.retinamd.com/

Med Device Monday: Diagnostic for Detection of Brain Trauma

Image from thepinetree.net

Image from thepinetree.net

Every once in a while, a "breakthrough" medical device promises to address unmet medical needs through its innovative technology. Such devices are reviewed by the FDA under their Breakthrough Devices Program, which allows for expedited development and release of the devices into the market. One such promising in vitro diagnostic device is for detection of mild traumatic brain injury (mTBI)—commonly known as concussion. The Banyan BTI (Brain Trauma indicator) is a biomarker-based, in vitro diagnostic blood test developed by Banyan Biomarkers, Inc. That's right! A blood test for brain trauma. Truly, we are living in the future. 

Traumatic brain injury (TBI) is an injury to the brain following a violent blow to the head. Accidents, sport-related concussions, and falls can all cause TBI. In turn, TBI can be classified as either Mild and Severe. Mild TBI, or mTBI, causes loss of consciousness for less than 30 minutes, resulting in cognitive dysfunctions such as memory loss, attention deficits, and mood swings. It is often missed at the time of initial injury. Severe TBI, on the other hand, causes loss of consciousness for more than 30 minutes. This is due to penetrating skull injury which can result in severe cognitive impairment and even a comatose state for the patient. According to the Centers for Disease Control and Prevention (CDC), in 2013 TBI resulted in approximately 2.5 million emergency visits and 282,000 hospitalizations out of which 94.5 percent of TBIs are mTBIs or concussions.

Banyan BTI detects the presence of two brain-specific biomarkers—UCH-L1 (Ubiquitin Carboxy-terminal Hydrolase-L1) and GFAP (Glial Fibrillary Acidic Protein)—which are quickly released into the blood following a concussion. Measuring these protein levels within 12 hours of a head injury can help identify intracranial lesions following an incident.

The current mode for detecting brain tissue damage is to use a neurological scale, called the 15-point Glasgow Coma Scale, followed by a computed tomography or CT scan of the head. The current methodology is defective in the sense that over 90% of patients with mild TBI have a negative CT scan. Moreover, the CT scan has the disadvantage of considerable radiation exposure to patients. Availability of a blood test for mTBI/concussion will likely reduce the amount of CT scans done—saving essential dollars for our health care system.

According to a multi-center, clinical study of 1,947 individual blood samples from adults with suspected mTBI or concussion, and compared with CT scan results, Banyan BTI was able to predict the presence of intracranial lesions with an accuracy of 97.5 percent. Banyan BTI was cleared by FDA via the de novo pathway, and it promises to be the first objective blood test that will help clinicians rule out the need for unnecessary CT scans in persons with mTBI.

These are exactly the types of breakthrough devices that FDA seeks to get to market: it's less invasive and risky for patients, and provides quick results at a lower cost. What's not to like? 


Further Reading:



Med Device Monday: The First Neonatal MRI

This week, FDA announced their clearance of the first magnetic resonance imaging (MRI) device for neonatal patients.

MRI is a diagnostic method used in radiology to make various pictures of the internal structures and organs of the body. Until MRI was approved for neonatal care, babies in neonatal intensive care units (NICUs) had to be taken out of the unit and brought to a traditional MRI suite, creating a variety of challenges and complications for this vulnerable population.

Photo from aspectimagining.com

Photo from aspectimagining.com

Exposure outside the unit to various illnesses and even the act of moving a very fragile newborn made getting these valuable (and even lifesaving) images problematic, to say the least. Further, traditional MRI units aren't designed for fragile newborns. 

The Embrace Neonatal MRI machine is designed specifically for infants. The child is placed in a temperature-controlled incubator which then is positioned in the machine. If quick access is needed, the baby can typically be accessed in about 30 seconds.

Check it out:

According to FDA's press release, the machine is designed "specifically for imaging of the neonatal head. The Embrace Neonatal MRI System may be used on neonates with a head circumference up to 38 centimeters and weight between 1 and 4.5 kilograms....The Embrace Neonatal MRI System is contraindicated for patients weighing more than 4.5 kilograms or with a head circumference of more than 38 centimeters. It is also contraindicated for all infants with metallic or electronically active implants since the MRI may cause tissue near the implant to heat or the implant to malfunction." Tiny babies! In these cases, MRI could be used to look for brain damage, hemorrhage, cranial abnormalities, etc. 

Healthcare for children and newborns is certainly more comprehensive than simply miniaturizing the adult version! But, in this case, it seems to have worked. I'm glad to see a device like this cleared, as I imagine it will be life-changing indeed.



Further Reading:

Clearance database entry

More info on pediatric devices

FDA's press release


Med Device Monday: Quicker Diagnosis for Concussion

Concussions have been a bit of a hot topic over the past few years. From little leagues to pro athletes, and even to the silver screen, more attention is being paid to these and other Mild Traumatic Brain Injuries (MTBI)—and with good reason. 

Mild brain injuries can be anything but mild. This category of trauma includes concussions (the most common type of MTBI), and symptoms can include pain and headache, nausea, vomiting, fatigue, drowsiness, changes in sleep patterns, and problems with balance or vision. While there is no treatment for MTBI, diagnosis means the patient can rest and avoid activities that will worsen the damage while giving it time to heal. Multiple concussions in a short amount of time can lead to longterm problems, like Alzheimer's and dementia, but can even cause immediate death.

Unfortunately, it previously hasn't been easy to diagnose MTBI. Some are visible on electroencephalogram (EEG), and others via computerized tomography (CT) scan. CT scans use low doses of radiation to see inside the body, while EEGs do not. This is where Brainscope comes in! Brainscope explains that, "According to recent publications, 95% of all head-injured patients who go to the Emergency Department present with mild symptoms. The vast majority of these head-injured patients receive a CT scan, of whom over 90% are CT negative for structural brain injury, creating needless radiation exposure to patients. The Ahead 300 has the potential to significantly reduce costs and wait times associated with hospital visits and unneeded CT scans." Ahead 300 also allows for a diagnosis on the spot, reducing the need for multiple medical appointments, and along with that, the risk that those appointments might get missed and the injury never be diagnosed.

Photo from brainscope.com.

Photo from brainscope.com.

Using a blend of EEG and proprietary technology, a single-use headpiece is attached to a handheld device. Algorithms are used to analyze brain wave patterns and spot anomalies, resulting in a diagnosis.

In announcing FDA's clearance, Brainscope also shared that, "The Ahead 300 was developed in partnership with the U.S. Department of Defense through six research contracts, and with over 20 clinical studies at 55 sites and 16 peer-reviewed publications." Check out the clinical trial that helped demonstrate the Ahead 300's improved accuracy and expanded indications over the Ahead 200 (expanded injury time window and expanded patient age range).

Med Device Monday: SEEKER System from Baebies

Baebies! No, not what Beyoncé is pregnant with.

When babies are born, they undergo routine screening for certain diseases that typically have better outcomes when detected early. Conditions tested for include, but are not limited to, heart conditions and congenital defects, early hearing detection and intervention, sickle cell (inherited red blood cell) disease, plus a range of conditions that can be detected in the blood. As the CDC states, "Newborn screening identifies conditions that can affect a child's long-term health or survival. Early detection, diagnosis, and intervention can prevent death or disability and enable children to reach their full potential. Each year, millions of babies in the U.S. are routinely screened, using a few drops of blood from the newborn's heel, for certain genetic, endocrine, and metabolic disorders, and are also tested for hearing loss and critical congenital heart defects (CCHDs) prior to discharge from a hospital or birthing center."

At the beginning of February, FDA approved marketing of a new device, Baebies' SEEKER, that will test babies for four rare metabolic disorders. Specifically, four Lysomal Storage Disorders (LSDs)–Mucopolysaccharidosis Type I (MPS I), PompeGaucher, and Fabry–that cause fats, proteins, sugars and other substances to not be eliminated from cells properly, due to low levels of the enzymes that usually help flush them out. If left untreated, these conditions can lead to life-threatening and life-ending complications including kidney and liver damage, neurological disability, stroke, heart attack, and more.

Per FDA, the Secretary of Health and Human Services "recently added Pompe and MPS I to the list of routine recommended newborn screening programs and it is anticipated that additional states will begin requiring use of screening tests to detect these disorders...Several states currently mandate LSD screening in all newborns, including Illinois, Kentucky, Michigan, Missouri, New Jersey, New Mexico, New York, Ohio, Pennsylvania and Tennessee. However, until today [February 3, 2017] there were there were no FDA-authorized devices for screening of these disorders. Availability of the Seeker System provides laboratories with a screening tool that has been reviewed by the FDA for clinical and analytical validity. The Seeker System, consisting of the Seeker LSD Reagent Kit- IDUA|GAA|GBA|GLA and Seeker Instrument, works by measuring the activity level of proteins required for healthy lysosomal storage found in dried blood samples collected from the prick of a newborn’s heel 24 to 48 hours after birth. The Seeker Instrument is a device that automates the analysis of dried blood spots. Reduced enzyme activity of proteins associated with any of the four LSDs detected by the kit may indicate presence of a disorder. Results showing reduced enzyme activity must be confirmed using other testing methods, such as biopsies, genetic and other laboratory tests."

Photo from baebies.com.

Photo from baebies.com.

The SEEKER integrates well with other tests currently performed as it is non-invasive and utilizes the heel prick that babies already get for other newborn testing. It tests dried blood spot specimens, meaning not much blood is required to carry out the test. The system is designed to be easy-to-use and results are provided on-site in fewer than four hours. Per the manufacturer, all that is required to set up a SEEKER testing work station is a desktop PC, back-up power supply, the required software, and four SEEKER instrument units that read the samples.

Per Baebies, "Newborn screening, widely recognized as one of the most successful public health programs in the U.S., ensures that all babies are screened for certain serious conditions at birth. The program started more than 50 years ago and has since expanded to include more than 30 metabolic and genetic diseases. The recent addition of Pompe disease and MPS I to the Recommended Uniform Screening Panel (RUSP) have brought more recognition to the benefit of early detection through newborn screening for LSDs."

Adding some quick and easy tests to the bevy of newborn testing–and in turn providing more positive long-term outcomes–is a win for all. 


Further reading:

Seeker System Classification Order