10 Medical-Device Wearables To Improve Patients' Lives
Wearable medical devices have expanded from hearing aids to everything from heartbeat monitors to pain management. Here are 10 medical wearables worth watching.
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Back in 1938, Chicago electronics manufacturer Aurex Corp. developed the first wearable hearing aid, marking one of the earliest steps into what has become the fast-growing medical device wearables industry.
The wearables industry, which includes medical devices, fitness and health gadgets, and infotainment devices like virtual reality gamer goggles and smartwatches primarily used for communication, is expected to grow to 170 million unit shipments this year, driving $20 billion in global manufacturer sales, said Shane Walker, principal analyst of digital health and wearable technologies at research firm IHS.
That's up 27% in unit shipments and a whopping 70% increase in revenue over last year, according to Walker. And the wearable medical device market is expected to contribute 30% of that revenue this year.
Between now and 2019, the medical-device wearables market is expected to increase revenue 8% annually and eventually see its slice of the ever-increasing wearables market shrink to 20% by 2019. While demand for medical-device wearables will still be persistent over the coming years, much of the money will be flowing to the infotainment wearables market. Smartwatches, for example, were the key driver of the 70% revenue growth the industry is expected to capture this year.
[Samsung, Huawei, HTC Show Off Smartwatches At CES.]
Medical-device wearables tend to target one of the four most prevalent chronic illnesses: congestive heart failure, diabetes, hypertension, and chronic obstructive pulmonary disease. For example, accurate glucose monitoring is not readily available in smartwatches today, but there are companies working to improve it, Walker said.
He added that wearable medical devices are becoming popular as the healthcare industry and consumers find early disease warnings hold the potential for reducing costly stays in the hospital. Walker pointed to the 2017 time frame for the electronic health records program, otherwise known as Meaningful Use, to kick in and likely "provide another source of momentum for the (medical-device wearables) category."
One of the greatest challenges for these wearable medical devices is receiving approval from the Food and Drug Administration (FDA).
"If it's a brand new device and addresses something that has never been done before, and it makes claims it will work, then it will take time to get FDA approval," Walker said. "Getting a medical device approved is not easy and it's expensive to get approved by the FDA."
Here's a look at 10 wearable medical devices in various stages of FDA approval that are worth keeping an eye on.
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The OvulaRing is designed to aid women in determining when they are ovulating and the most fertile to conceive a child. The wearable device is inserted into the vagina, similar to using a tampon, and then the biosensor monitors core body temperature throughout a woman's menstrual cycle. VivoSensMedical GmbH, the maker of the OvulaRing, is working on FDA approval for the device and hopes to receive it in 2016. The device received CE approval in Europe and is currently marketed in that region. The cost for the system ranges from 254 euros ($276 US), for a three-month starter package to 478 euros ($520) for a 12-month package.
HealthPatch MD is a biosensor developed by Vital Connect that measures and tracks a patient's heart rate, respiratory rate, skin temperature, and body posture. It includes fall detection and can be used in a hospital, at home, or at an outpatient facility. HealthPatch MD has regulatory approval to be sold in the US, Europe, and Japan.
Healthcare company Abbott designed a wearable continuous glucose monitoring system for people with diabetes. The device seeks to replace the need for users to rely on blood glucose meters. The FreeStyle Libre Flash Glucose Monitoring System has received regulatory approval to be sold in Europe and India, and Abbott is currently undergoing the FDA approval process.
The MiniMed 530G System with Enlite Sensor is designed to act as an artificial pancreas, a gland inside the abdomen that aids the digestive system and controls blood sugar levels. This wearable device, developed by Medtronic, monitors glucose levels and automatically dispenses insulin in way that mirrors that of an actual pancreas. The MiniMed 530G has FDA approval.
Animas has developed the OneTouch Ping, a remote meter that works in conjunction with the OneTouch Ping Insulin Pump to aid diabetics with their insulin intake. The meter is also designed to factor in and correct for high blood sugar levels and carbohydrates in food. The device has FDA approval for diabetics who are insulin dependent.
The Zio XT Patch, developed by iRhythm, aims to detect abnormal heart activity over an extended period of time. These wearable electrocardiogram patches are water-resistant and can be worn continuously, around the clock, for two weeks. The data that is collected by the patch is then transmitted to iRhythm's clinical app, which relies on algorithms to delve into the results. The Zio XT Patch has FDA approval.
NeuroMetrix created a wearable called Quell, which is designed to reduce pain. This wearable device uses an accelerometer to gauge a user's activity level and adjust its stimulation intensity to alleviate pain. The device uses Bluetooth technology to connect to a smartphone app, where a user can control the device's features and track therapy and sleep results. Quell has received FDA approval and is sold over the counter.
Dexcom received FDA approval in August for its new G5 Mobile Continuous Glucose Monitoring System, which is designed to transmit blood sugar level data from the sensors worn by the user to a smartphone. With the G5, users will not need to carry a separate receiver for the wearable device. According to Dexcom, the G5 is the first fully mobile continuous glucose monitoring system that is FDA approved for both adults and children as young as 2 with diabetes.
The WristOx2 is a pulse oximeter that handles such tasks as monitoring and measuring users' heart rate and blood oxygen levels. This wearable medical device from Nonin Medical is targeted toward people who have asthma and are at risk of congestive heart failure and chronic obstructive pulmonary disease (COPD). The device can be used in the hospital and when the patient goes home to allow remote and extended monitoring of their heart rate and oxygenation.
The smart hearing technology developed by Sivantos for Siemens is designed to automatically zero in on a person's speech while minimizing background noise. The wearable devices aim to quiet background noise, synchronize hearing aids, and connect wirelessly to a smartphone. The smart hearing aids have FDA approval and are on the market in the US. While cost varies depending on the hearing care provider selling the device, they can range from approximately $2,000 to $3,000. However, Siemens has released a new line of smart hearing aids that feature some of the higher-end features but at a lower price point, ranging from $1,000 to $2,000.
The smart hearing technology developed by Sivantos for Siemens is designed to automatically zero in on a person's speech while minimizing background noise. The wearable devices aim to quiet background noise, synchronize hearing aids, and connect wirelessly to a smartphone. The smart hearing aids have FDA approval and are on the market in the US. While cost varies depending on the hearing care provider selling the device, they can range from approximately $2,000 to $3,000. However, Siemens has released a new line of smart hearing aids that feature some of the higher-end features but at a lower price point, ranging from $1,000 to $2,000.
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