Find out more about the switch to the Medical Self.
When you look at consumer health tech, you see a lot of ideas that fit more into the murky wellness category over medical. The reality is that device FDA approval or clearance is a complex process including over 1700 types of devices.
The regulation process can last up to 18 months and this is after a company has completed rigorous medical trials, There’s even now startups such as Enzyme to guide startups through the regulatory and compliance lifecycle.
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This year at CES, it seemed that health tech was getting a lot more serious. While there’s plenty of biometric data being collected without any real path to behavioral change — most people know they snore already, for example, the data collected in becoming more complex. We’re also seeing some devices looking at treating conditions that greatly impact a person’s wellbeing that has been underlooked. Let’s take a look.
Withings Scan Watch
Withings unveiled ScanWatch at this year’s CES, the world’s first clinically validated hybrid smartwatch to detect both risks of arrhythmia (AFib) and sleep apnea. Developed by cardiologists and sleep experts, It is Withings’ most medically advanced wearable to date, helping users and their physicians monitor overall health with a smartwatch that identifies highly prevalent, yet largely underdiagnosed cardiovascular and sleep issues.
Since AFib symptoms are irregular or may not even be known to users, ScanWatch offers a new early warning detection capability. Through its embedded PPG sensor, the device can continuously monitor heart rate, which allows it to alert users to a potential issue even if they don’t feel palpitations. When ScanWatch detects an irregular heartbeat through its heart rate sensor, it will prompt the user via the watch display to take an ECG reading.
When users do experience symptoms or have been alerted of an abnormal heart rate, they can easily take an ECG, in just 30 seconds, through three built-in electrodes by simply touching both sides of the bezel. During the measurement, users can see the live electrocardiogram displayed on the watch screen or in the accompanying Health Mate app. All data collected can easily be shared with a doctor or healthcare professional.
ScanWatch can detect the presence of night sleep apnea episodes through a SpO2 sensor that emits and absorbs a light wave passing through blood vessels. All night long, it measures oxygen saturation levels to identify when levels are inadequate due to breathing disturbances such as sleep apnea. It’s worth noting that sleep apnea can only be properly diagnosed and treatment recommended through a sleep study, but this may be the wake-up call needed for a largely underdiagnosed condition, especially in women.
We won’t see this in the US for a few months yet as it’s currently waiting for FDA approval.
Valencell Blood Pressure Monitoring
When it comes to wearable tech, Valencell is probably the most respected company there is, with over ten years in operation and a team of optical, mechanical, electrical engineers, and exercise scientists. Their innovations are backed by over 80 granted patents and another 100+ pending. They’ve integrated biometric sensor technology into more than 45 different devices that have come to market.
Blood pressure monitoring is one of the hardest biometrics to incorporate into wearable tech. Valencell has developed the world’s first calibration-free, cuff-less blood pressure monitoring technology for wearables.
The technology works using PPG-only in the ear or at the finger – no ECG, no pulse transit time or other methodology. That means one sensor, one location on the body for simple integration and ease-of-use. The technology can be integrated into consumer earbuds, hearing aids, or finger-based implementations on mobile devices, pulse ox clips or other similar devices
It’s been tested with more than 30,000 data sets in more than 4,000 subjects around the world, and it’s currently being validated in a clinical study to demonstrate it meets the ISO 81060-2:2013 standard. Valencell now has evaluation kits available for device makers to independently test and validate the technology.
Laser 272 PowerFlex Cap
Ok, let me start by saying this one’s FDA cleared. It’s a hat embedded with 272 “medical grade” lasers to treat hair loss.
According to the company the cap:
“Delivers nourishing laser light to your hair follicles to reduce inflammation and stimulate cellular energy to create a healthier environment for hair growth. This boost of laser light may encourage blood flow to the follicle, bringing in more oxygen and nutrients, activating antioxidant defences and speeding up the elimination of DHT.”
What’s interesting is that the promotion material includes photos of women wearing the hat – an untapped customer in the hair loss market? Does it work? To be honest, I have no real idea, but surely it’s time for tech innovation to treat an all too common problem.
The Elitac Balance Belt
Elitac develops wearables combining the integration of electronics and textiles, specializing in the development of haptic wearables. The Elitac Wearable Lab conducts R&D in technology that communicates with the user via touch or vibration.
The BalanceBelt helps people living with BVL (Bilateral Vestibular Loss) or a balance disorder that affects their ability to walk, by providing insight into the position of the body. It continuously measures in which direction the user is leaning and gives feedback using vibrators. The belt is activated by the press of a button, making it extremely easy to use. It is worn around the waist and includes small vibration motors that release a vibrating alert if the patient’s body is at risk of being thrown off balance.
The haptic technology developed by Elitac encourages the wearer to subconsciously correct their posture themselves.
Elitac is also working on an interesting Mission Navigation Belt designed for hands-free and intuitive haptic navigation for soldiers in the field. It provides fast information flow and increases agility through haptic sense, simultaneously reducing the load on hands, eyes, and ears. Currently, the belts are being tested by the NL Ministry of Defense and will be commercially available in 2020.
ClearUP Sinus Pain Relief
ClearUP Sinus Pain Relief is life-changing for anyone who suffers from seasonal allergic rhinitis or year-round allergies. It uses gentle microcurrent waveforms to reduce allergy-related sinus pain. To use, simply glide the tip along the outside of the cheek, nasal bone and under the brow bone for a quick five-minute treatment.
ClearUP guides the user to the most optimal treatment points with a light and vibration system. As the device vibrates, it delivers a low-level, proprietary electrical stimulation waveform called microcurrent that stimulates sinus nerve fibers under the skin of the face.
The device was FDA cleared in January 2019, and research reveals four out of five experienced sinus pain relief after one five-minute treatment.
WAHU Adaptive Sole
This is the kind of tech that if it’s done well, we’ll wonder how we ever did without it. WAHU is an active shoe sole that can adapt to changes both in the external environment, like terrain, temperature or humidity, and in the dynamic state of the user.
It works according to a series of interconnected chambers, with a particular bellow structure, filled by fluid through a miniaturized electroplunger, able to be locked and unlocked. This mechanism allows the sole volumetrics changes and, consequently, its grip and cushioning.
Micro-compressors, interconnected cavities and artificial intelligence allow the user to select, through an app, the settings that maximize performance and comfort in any situation, from indoor surfaces to trails, trekking, and urban surroundings.
Wahu can generate a digital signature for the user based on their stride, analyze plantar (foot arch) pressure or prevent falls. The idea of fiddling with an app isn’t terribly appealing but perhaps a more instinctive responsive shoe will be available in the future? It’s ostensibly a prototype, their appearance at the show is an opportunity to gain interest from shoe manufacturers.