Tag Archive for: medical device

Wearable health-tracking devices have soared in popularity over the last decade as fitness enthusiasts look to quantify their activity. But the technology is also finding a welcome home in the medical world, where patients with chronic conditions are using it to monitor their day-to-day health.

The Embrace is a wrist-worn smart watch from Massachusetts Institute of Technology spinoff Empatica. It recently received FDA clearance to detect the most severe kinds of seizures for patients with epilepsy, as well as track their frequency and duration. The company raised nearly $800,000 on an Indiegogo campaign back in 2015 to get the product off the ground, hitting more than 500% of its funding goal.

Machine-Learning Monitors Seizure Indicators

Epilepsy affects 65 million people worldwide. In the U.S., 1 out of every 26 people will be diagnosed with the seizure disorder at some point in their lives, according to the Epilepsy Foundation. Early detection and warning systems for epilepsy sufferers can save lives or prevent serious injury brought on by a severe convulsive seizure, and Empatica has positioned itself to be one of the leaders on developing that critical technology.

The $249 Embrace uses advanced machine-learning capabilities to help patients and their caregivers closely monitor their seizure activity. It measures several different seizure indicators, including electrodermal activity — a signal associated with the fight or flight response. Such activity is studied by stress researchers to note the physiological changes that accompany a seizure, according to MedCityNews. The Embrace also monitors sleep and physical activity levels, which patients can use to correlate with what triggers a seizure for them.

The success rate in clinical trials of the Embrace have been promising to say the least. The 135 patients tested across multiple epilepsy monitoring sites were fitted with the device while also being continuously monitored with video-EEG. Throughout 272 days, 6,530 hours of data was recorded, and the Embrace’s algorithm successfully detected 100% of the patients’ seizures, according to Empatica.

The Embrace comes with an accompanying subscription-based app which can instantly alert caregivers to the onset of a seizure via SMS or by phone, even notifying them of their patient’s location. The app can also be used to remotely monitor the functionality of the device. For now, the Embrace is not available over the counter, requiring a prescription from a neurologist.

Competition Heats Up for Advanced Warning Systems

Having epilepsy is something many patients are reluctant to admit to friends or family, which is why the device was designed with attractive aesthetics in mind as opposed to an overtly medical appearance. This enables users to wear the device as they would any other wearable fitness or sleep tracker without alerting the general public to their condition, a valuable privacy measure for those who don’t wish to broadcast their condition while still getting the benefits.

The Embrace is not the only device out there with the goal of detecting seizure activity. Others have developed similar seizure detection systems to collect and share data with doctors to give them a picture of their patients’ condition between regular appointments.

SmartMonitor initially developed a smart watch to detect shaking similar to a convulsive seizure, and recently released its technology in the form of an app for Apple Watch. THREAD Research also developed a smart watch app used to track epileptic seizures for ResearchKit in association with Johns Hopkins University.

Detecting and identifying seizures is a good start toward empowering sufferers of epilepsy to track their condition in real-time, but the next frontier for developers of such technology will be to create systems that warn patients even before a seizure occurs.

With millions of epilepsy sufferers in the U.S. alone, demand for such technology is strong, and it will likely not be long before advance seizure warning systems become reality.

Achieving medical software and hardware compliance is less stressful when developers and stakeholders have a structured, detailed and easy-to-use data information management process in place. Learn more in our white paper, “Application of Risk Analysis Techniques in Jama to Satisfy ISO 14971.”

After kicking off with a rare torrential downpour in Las Vegas that forced even Google to seek shelter, the 2018 Consumer Electronics Show — better known as CES — officially concluded on Jan. 12.

CES is an annual tech-stravoganza where companies large and small descend on Sin City to unveil their latest innovations.

Although the booths and displays have been taken down and packed up, the products and technology unveiled throughout the week will undoubtedly shape the coming years across many sectors.

Here are some quick highlights, and stay tuned for a look at CES 2018 announcements from the autonomous vehicle sector later this week.

Artificial Intelligence

Any direction you looked in Las Vegas last week, chances are you saw the words “Hey Google” (the Google Home wake word) festooned on everything from billboards to the Las Vegas monorail.

Google’s voice-powered smart home assistant is clearly giving Amazon’s Alexa a run for its money in spite of its first-mover advantage.

Alexa was also a prominent player at CES this year as well, with devices ranging from watches to robots to home appliances and yes, even toilets, starting to incorporate Amazon’s proprietary AI engine.

Elsewhere, while Samsung used the event to show off the latest version of its smart home assistant, Bixby, AI like Apple’s Siri/HomeKit and Microsoft’s Cortana were all but unseen, according to numerous reports.

This means Apple and Microsoft may have some serious ground to make up — at least, in terms of perception — as CES 2018 cemented Amazon and Google’s dominance in the space.

Consumer Electronics

The concept of a smart home is morphing beyond voice-enabled speakers and smart thermostats. Based on some of the reveals at CES this year, it won’t be long before every room in the house is equipped with some form of AI smarts.

Kohler’s Verdera smart mirror was on display at CES, which brings the full suite of Amazon’s Alexa voice controls to your bathroom. The Verdera enables voice control like other smart home devices, including adjusting lights and temperature, playing music, and more, all during your morning routine.

Also featured by Kohler was its DTV Prompt, a smart showerhead (also Alexa-enabled, no surprise there) that allows you to, using voice control, turn on your shower, adjust the flow and temperature, and even create pre-set personalized shower setting profiles for multiple-member households.

LG showed off its ThinQ smart refrigerator, a smart fridge that seems straight out of the future. The ThinQ has a 29-inch touchscreen display running WebOS that becomes transparent with two knocks, enabling users to see inside the fridge without opening the door. It also lets you enter your food’s expiration dates, which triggers reminders when something is about to spoil or when you’re running low on supply. It’s even got a camera inside the fridge so you can view its contents remotely, putting an end to the “do we have any butter?” questions at the supermarket.

Health and Wellness

CES 2018 was also a big showcase for some exciting emerging technology in the health space, much of it focusing on giving patients the ability to more efficiently monitor their well-being and even self-diagnose.

The EyeQue Insight, for example, is a viewer and mobile app that lets people test their own vision. Insight uses the same test done in an eye doctor’s office except on mobile phones, which the company told ExtremeTech lets people determine whether or not they need glasses, or whether their need to make updates to an existing prescription.

Eargo is making a run at the hearing aid business. The company’s on-site audiologists determine whether the user needs a hearing aid, and when the device arrives at your home, it’s already properly tuned, charged and ready to wear. It also incorporates fiber materials and an innovative fit, making it nearly invisible when worn.

Sleep is a cornerstone of good health, and the Nokia Sleep is looking to give you a detailed look at your body’s functions as you hit the hay, utilizing smart sensors and a mobile app to track everything from heart rate and breathing patterns to snoring.

The resulting data is then crunched, giving you a “sleep score” and even estimating how much deep, restful REM sleep you get in a typical evening. It can also be integrated into home automation devices to adjust lighting or temperature to optimize your slumber.

As the global population continues to explode, the world’s healthcare systems are straining to keep up with increased demand.

That’s why some outside-the-box thinking is necessary to keep the planet’s population healthy as it inches ever closer to 10 billion people.

Recently, at the second-annual Health++, Stanford’s Health Hackathon, some of the brightest engineering, product design and technology minds in the world came together to put their knowledge and passion to use in an attempt to alleviate some of the world’s heaviest health challenges.

More than 300 flocked from all corners of the globe to Stanford University in Stanford, California, for a caffeine-fueled weekend of coding and prototyping health tech products and apps. The following are six of our favorite innovations to come out of the hackathon.

YourPacifier
One of the hackathon’s winners, YourPacifier is a smart pacifier that monitors an infant’s hydration levels. While in use, YourPacifier continually senses the humidity of a baby’s lips, sending gathered data to an accompanying app.

When an anomaly is detected, the app alerts the parents, prompting them to answer some basic questions, which then determines whether re-hydration or even hospitalization may be necessary. The pacifier even includes an oral rehydration solution, which can be automatically administered in the event the child becomes severely dehydrated.

The team was inspired to create YourPacifier after seeing many children with severe dehydration in hospitals in Asia and the Pacific Islands, and learning that dehydration and diarrhea kill more than half a million children under age 5 each year.

Mobile EMT AppMobile EMT
When faced with a sudden injury, seconds count in determining what steps are necessary to get the appropriate medical attention.

Mobile EMT is a mobile solution that provides doctors with real-time access to your vital signs from anywhere in the world.

The system allows doctors to evaluate patients remotely and determine whether specialist intervention or hospitalization is necessary, or provide general medical assistance.

The idea is to equip EMTs with an app and a wireless device capable of recording vital signs. The device’s findings are then broadcast to doctors who specialize in treating the specific condition afflicting the patient.

MediBot
Chatbots are all the rage this year. MediBot harnesses that technology to give the nation’s 70 million low-income Medicaid patients easy access to detailed information on the program, as well as connect them to a physician who accepts it.

Using a Facebook Bot, patients can send messages 24 hours a day from anywhere to do everything from determine Medicaid eligibility, to find out who to call if you lose your insurance card. It even places automated calls on your behalf to check your Medicaid enrollment status.

The development team chose Medicaid recipients because they felt it’s a population currently underserved by innovators.

NutriLink
NutriLink AppIn the developing world, child malnourishment is a pervasive and deadly problem. In India, a lack of centralization of the government’s nutrition centers limits their usefulness, leaving children in desperate need going without treatment.

NutriLink allows users to locate the nearest government-run nutrition centers across India using Google Maps, displaying all local centers in an easy to read interface.

It can provide real-time information about capacity and bed availability at the centers, as well as contact information and directions.

Alexassist
As the world’s population ages, more people than ever are living with chronic medical conditions that need regular monitoring for the patient to stay healthy and live a longer life.

Leveraging Amazon’s Alexa voice assistant, Alexassist is designed to help patients monitor their chronic health conditions, such as diabetes, with a simple, voice-controlled interface.

The program, built using a Raspberry Pi 3, can even alert relatives if the patient’s health takes a turn for the worse. It acts as a sort of virtual in-home healthcare provider, offering helpful reminders to users to take medication or test their blood glucose levels.

Found in Translation
Effectively communicating with a physician is a critical aspect of patient care, but what happens when the doctor and patient don’t speak the same language?

Enter Found in Translation, an app that acts as an interpreter, providing real-time translation of conversations between doctor and patient.

Using voice recognition and Google Translate, the app allows both parties to communicate freely — in their native languages — to impart critical health information or diagnoses.

These were just some of the products and apps the hackers created at this year’s event. The innovation on display is all the more impressive considering each team built or developed their ideas from scratch over the course of a weekend.

There’s truly some incredible thinking happening in the health tech space, and we expect we will continue to see even greater things to come.

The future of healthcare is evolving rapidly, and companies building forward-thinking medical devices and related-products must also ensure they’re meeting modern quality and compliance standards. Learn how Jama Software can help by reading this profile of RBC Medical Innovations.