de novo pathway

Med Device Monday – De Novo Clearance of The Miris Human Milk Analyzer

Breast milk is often considered a “superfood” for babies; it contains the appropriate vitamins, minerals, and nutrients to support a baby’s growth and development (not to mention hormones and enzymes that promote maturation and digestion, and antibodies that help the baby resist infection!). It’s no wonder why breast milk is often referred to as “nature’s first health plan.”

Yet for infants born preterm (before 37 weeks gestation), or with certain health conditions, breast milk may not contain sufficient protein or provide enough energy. For these infants with increased nutritional needs, knowing the macronutrient content of the breast milk being provided could give vital information to the health care team and parents, allowing them to make informed decisions on how to fortify the breast milk based on the individual needs of the infant.

In December 2018, the U.S. Food and Drug Administration permitted marketing of the Miris Human Milk Analyzer (HMA) to Miris AB of Sweden. The Miris HMA uses an infrared spectroscopy system to analyze samples of human milk, and provides a quantitative measurement of fat, protein and total carbohydrate content, as well as calculations of the total solids and energy content contained in the milk. The prescription device is intended for use by trained health care personnel at clinical laboratories, providing healthcare professionals with a new tool to aid in the nutritional management of newborns and young infants at risk for growth failure due to prematurity or other medical conditions.

FDA reviewed the Miris HMA test through the De Novo premarket review pathway, a regulatory pathway for low-to-moderate-risk devices of a new type. Along with its granting, FDA established a list of special controls to provide for the accuracy and reliability of tests intended to measure the nutritional content of human milk to aid in the nutritional management of certain infants. These special controls, when met along with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. As discussed in our previous blogs about the De Novo pathway, this action also creates a new regulatory classification; meaning subsequent devices of the same type and intended use may go through FDA’s 510(k) process.

Already on sale in over 25 countries worldwide, the Miris HMA is now available to analyze breast milk and guide the individual nutrition of preterm babies in the U.S. The new device supports Miris’ mission, “to make individual nutrition, based on human milk, available globally to improve neonatal health.” We’re excited to see a new device on the market that has the potential to help one of the most vulnerable patient populations. Go babies!


Additional Reading:

1.      FDA Press Release

2.      De Novo Letter for The Miris Human Milk Analyzer

3.      NIH: Do breastfed infants need other nutrition?

4.      CDC: Breastfeeding

5.      Miris Website

Med Device Monday: ThermoNeuroModulation Device to Treat Migraines

It’s Medical Device Monday! As excited as we are here at AcKnowledge RS about Mondays, it is known by many as #MigraineMonday on social media. Well, today we have some exciting news for sufferers: a stimulator by Scion NeuroStim LLC called the ThermoNeuroModulation (TNM) Device. Although it is currently for prescription use only, it is still a step forward for those who experience migraines.

IMAGE FROM http://www.accessdata.fda.gov/fda.gov/cdrh_docs/reviews/DEN170023.pdf

IMAGE FROM http://www.accessdata.fda.gov/fda.gov/cdrh_docs/reviews/DEN170023.pdf

Over 39 million Americans suffer from migraines; 2-3 million of those 38 million suffer from chronic migraines. During a migraine, a person may experience a variety of symptoms including vertigo, pain, sensitivity to light, or nausea. Some people suffer from vestibular migraines that cause repeated bouts of dizziness and may or may not include headache. Vestibular migraines can also lead to issues with balance, extreme motion sensitivity, vomiting, and feeling disoriented.  

Migraine treatments for traditional migraines are relatively limited; you can take pain-relieving medications or preventive medications, depending on the severity and frequency of your migraines. Pain-relieving medications can range from ibuprofen to opioids. Preventive medications include cardiovascular drugs, antidepressants, Botox, and even anti-seizure drugs. Both approaches clearly involve the use of pharmaceuticals, and unfortunately may not alleviate pain or prevent migraines from happening again.

The TNM Device is a non-drug solution for migraines that was granted through the de novo process in April 2017. Per the device description in the FDA de novo Classification Request:

“The TNM Device is intended to stimulate the vestibular system using tightly controlled thermal waveforms. The TNM Device is indicated for the prophylactic treatment of episodic migraine in adolescent and adult patients 12 years or older.”

The device is a non-invasive, home-use, DC-powered device that uses an over-the-ear headset with metallic earpieces that protrude into the external ear canals. While the user reclines and relaxes during treatment, the earpieces change temperature from 16-42°C. The controlled thermal fluctuations interact with the user’s vestibular system, causing changes that are used to treat their migraine headaches. The control unit with touchscreen display allows the patient to manage the treatment.

The TNM Device was studied in a multi-center, triple-blind, placebo-controlled, randomized study. Half of the patients were treated with the device while the other half received a placebo device. After three months of treatment, patients experienced a 21% decrease in total headache pain scores and the duration of migraine days decreased from 7 to 4.

The de novo pathway provided a mechanism for devices such as the TNM Device to undergo FDA review even though there are no other devices like it on the market. We hope that this device can help those who suffer from migraines. After all, don’t we all want a migraine-free Monday/week/life?

Are you interested in the de novo pathway? Check out our original blog post and update about if the de novo pathway is right for your device!

Additional reading:





Med Device Monday: Help for Dry Eyes by AesculaTech

How is it October already? Soon it’ll be November and time to VOTE (don’t forget!)

Every year since we started the AcKnowledge RS blog, we’ve dedicated a month to medical devices that have not yet received FDA approval. It’s an easy way to see what cool things people are inventing, and maybe give you a small glimpse into the future. Who knows, you might be able to “ask your doctor whether Device XYZ is right for you” in the next few years!

We start this month with AesculaTech, named after Asclepius, the Greek god of healing. This LA-based biomedical startup is developing a thermally responsive hydrogel for treatment of dry eye syndrome. Dry eye syndrome is pretty much what it sounds like: a prolonged absence of adequate lubrication and moisture on the surface of the eye. Symptoms of dry eye include constant eye irritation, stinging, burning or scratchy sensation in the eyes, sensitivity to light, redness and blurred vision or eye fatigue. There are a host of factors that increase your risk of having dry eyes, including prolonged computer use, frequent flying, birth control pills, smoking, contact lens wear, diabetes, arthritis, antihistamines, allergies, and aging. So pretty much “living” can lead to dry eye! A 2012 Gallup poll showed that more than 26 million Americans suffer from dry eyes, and this number is expected to increase to more than 29 million within 10 years.

There are prescription medications as well as over-the-counter (OTC) eye drops currently used for the treatment of dry eye syndrome. Unfortunately, many prescription medications need to be used for a long time before any improvement in the condition is evident, and OTC eye drops (artificial tears) only bring temporary relief and require frequent reapplication.

AesculaTech’s propriety material, the AesculaGel, is unique in that it can achieve three different states of matter. AesculaTech co-founder and chief science officer Niki Bayat refers to the AesculaTech Gel as “Reverse Chocolate” as at low temperatures, the AesculaGel is a liquid. However, as it warms up it turns into a gel, only reaching solid state when it hits body temperature.

eye.closeup

To simplify, the liquefied AesculaGel is injected by your doctor into your tear duct which then solidifies as it reaches body temperature. A tiny plug forms that prevents tears from draining away from the surface of the eye. This procedure is intended to be performed during a quick, in-office procedure and last for about a year.

Pre-clinical animal trials using AesculaGel have shown statistically significant increases in tears in the eyes. The company is now preparing for human clinical trials before a pre-market submission to FDA.

According to Aesculatech, AesculaGel is initially being tested for the treatment of dry eye syndrome but there are plans to use the gel for the treatment of glaucoma. According to Bayat and co-founder Andrew Bartynski, AesculaGel has a wide range of potential applications, including pharmaceuticals, medical devices, cosmetics, and textiles. Moreover, since AesculaGel could be used for sustained, localized drug delivery therapies, patient non-compliance to drug regimens to treat chronic conditions could also be potentially addressed.

Additional Reading:

1.       More info about AesculaTech

2.       Future plans for the AesculaGel for drug delivery

3.       More info from NIH about Dry Eye

Med Device Monday: BONEBRIDGE by Med-El

Hearing loss is the third most common health problem in the U.S after heart disease and arthritis. It is estimated that about 48 million Americans have some form of hearing loss, often caused by illness, genetics, or other ear-damaging elements that come with a modern lifestyle (e.g. sporting events, airplanes, concerts, and working with heavy machinery). FDA recently granted a de novo request for the BONEBRIDGE device, manufactured by Austrian company, Med-El. BONEBRIDGE is an active bone conduction implant system, and is designed for individuals 12 years and older who have conductive hearing loss, mixed hearing loss, or single-sided deafness.

To understand who should use this device, we need to understand a little more about the types of hearing loss. Hearing loss can be categorized into 4 categories:

  • Conductive: Any problem in the outer or middle ear that prevents sound from being conducted properly.

  • Sensorineural: Hearing loss that results from missing or damaged sensory cells (hair cells) in the cochlea and is usually permanent.

  • Mixed: As the name suggests— is a combination of conductive and sensorineural hearing loss, indicating damage in both the outer or middle ear, and the inner ear.

  • Neural: Neural hearing loss results from the lack of or damage to the auditory nerve, which is a bundle of fibers that carries auditory sensory information from the cochlea to the brain.


Traditional cochlear implants help patients who have sensorineural hearing loss as they replace the functional components of the inner ear (read more about cochlear implants on our blog from May 2016)! Alternatively, BONEBRIDGE is indicated for conductive or mixed hearing loss, which means sound cannot take the natural route through the outer and middle ear to the inner ear. This makes it difficult for the hearing loss sufferer to hear soft sounds and can also lead to the muffling of louder sounds.

Image from www.medel.com/us/bonebridge

Image from www.medel.com/us/bonebridge


BONEBRIDGE transmits sound waves via bone conduction directly to the inner ear, where they are processed as natural sound. The device consists of two components: an externally worn audio processor (called SAMBA), and a surgically-inserted bone conduction implant (called the BCI 601) which lies directly beneath the skin. The audio processor is held directly above the implant using magnetic forces.

Now, let’s get into the specifics of how this device works! Initially, the microphones of the audio processor pick up the sound waves. Then, the audio processor converts those sound waves into electrical signals, which are then transmitted through the skin to the implant. The implant, which is fixed in the temporal bone, converts these electrical signals into mechanical vibrations which are transmitted to the skull. The bone then conducts these vibrations to the inner ear. Signal transmission to the inner ear via bone conduction bypasses the outer and the middle ear, solving the complication of sound’s inability to pass through the natural route that comes with conductive and mixed hearing loss. The inner ear then processes these mechanical vibrations in a way that is similar to the way natural hearing is processed, and transmits nerve signals to the auditory nerve in the brain.

The audio processor is equipped with adaptive directional microphones, which adapts to different environments and individual usage. One of the really cool things about the audio processor (not that the device isn’t already super cool) is that it automatically identifies and minimizes noise interference in situations where there is loud background noise, which can become overwhelming to people who aren’t used to those background noises. The audio processor also comes with a remote control that has wireless connectivity capabilities. Using this remote control, the users can select different programs that have various settings depending on the user’s current environment or activity.

FDA classified BONEBRIDGE under product code PFO as a Class II device with special controls. These special controls include:

1.       Clinical performance testing

2.       Non-clinical performance testing (includes impact testing, mechanical Integrity testing, etc.)

3.       Biocompatibility testing

4.       Sterility of the patient-contacting components of the device

5.       Shelf life of the device

6.       Wireless compatibility, electromagnetic compatibility, and electrical safety

7.       Software verification, validation, and hazard analysis

8.       Labeling

 

We’re so excited to see medical technology like this enter the US market!

Additional Reading:

1.       FDA Classification Order

2.       Video explaining how the BONEBRIDGE works

3.       More info about BONEBRIDGE

4.       More info about the de novo process HERE and HERE

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/