Over the past year, MobiHealthNews has covered 36 devices that received clearance from the Food and Drug Administration. While connected blood glucose monitors and devices incorporating heart rate sensors dominate the list, we also saw more apps and software clearances, as the regulatory agency continues to evolve its position and expertise on how to regulate digital health tools. It’s been an interesting year for FDA news, and we’ve put together an analysis of what’s going on here. Read on for the 36 FDA clearances of 2016.
Israel-based startup Biogaming received FDA clearance for its YuGo Microsoft Kinect-based physical therapy system. Physiotherapists can use the system to create personalized gamified routines for patients, which patients can then complete at home using an Xbox or a computer connected to a Kinect device. The system tracks patients’ movements, automatically creating a record of the therapy. It appears that the company may have gone out of business while awaiting FDA clearance.
Also based in Israel, Labstyle Innovations secured FDA 510(k) clearance for its smartphone-connected glucometer called Dario. The glucometer syncs with a companion app and is small enough to fit in someone’s pocket. Dario consists of a glucose meter, a disposable test strip cartridge, and lancing device. The companion app, available on iOS and Android devices, includes a nutrition guide, logbook, and monitoring system. The app allows users to view all their information as well as insights and patterns in their data.
Switzerland-based Sensimed announced it received a de novo FDA clearance for its connected contact lens, Triggerfish, which helps physicians track the progression of glaucoma in patients. The sensor-embedded contact lens will record continuous ocular dimensional changes for 24 hours. The data is sent from the lens wirelessly to a recorder that users wear around their neck. After the recording period has ended, the data is transferred from the recorder to a physician’s computer via Bluetooth — meaning the patient needs to return to the physician’s office to upload it.
Lowell, Massachusetts-based InfoBionic received FDA 510(k) clearance for its remote patient monitoring system, MoMe Kardia, not to be confused with AliveCor’s recently product portfolio rebrand, which is also now named Kardia. The MoMe Kardia is designed to help detect cardiac arrhythmias in patients by sensing ECG, respiration, and motion. The lightweight monitoring device can be worn as a necklace or belt attachment. A first generation of MoMe Cardia already received FDA clearance, but that version was never commercialized.
Neurometrix got FDA clearance for a new smartphone-controlled version of Quell, its wearable for pain relief. Like its predecessor, the device will use nerve stimulation to treat chronic pain by sending signals to the brain that cause it to release natural opioids. It’s worn around the calf. The new device will let the user directly control the nerve stimulation — they can turn it on and off and increase or decrease therapy levels, and toggle between two different validated therapy modes, one which feels like a constant vibration and one that feels more like a fast pulse.
Wing, an app-connected spirometer from St. Louis, Missouri based Sparo Labs received an over-the-counter clearance, meaning the company can market it directly to consumers, but Sparo sees provider and pharma channels as important ones too. With Wing, Sparo aims to help people manage asthma and other respiratory conditions, such as COPD and cystic fibrosis, with a pocket-size sensor and corresponding app to track lung function.
Redwood City, California-based smartphone-connected breast pump startup Naya Health, which makes a device called the Smart Pump, received FDA clearance for its first pump system. The Smart Pump uses a hydraulic system instead of air to collect breastmilk. As a result, the pump is more comfortable and quieter, according to the company. Some data from the system, including how often a mother pumps, is sent to a companion smartphone app, called Naya Health Tracker. The app also allows users to track pumping sessions, record their child’s feedings, and manage breastmilk inventory by telling users which milk in their fridge needs to be used first. The company is developing an Apple Watch app as well.
Withings, the French connected device maker recently acquired by Nokia Technologies, received FDA 510(k) clearance for Withings Thermo, the company’s WiFi-enabled thermometer. The device was first announced in January at CES in Las Vegas. Rather than being inserted in the mouth or armpit, Thermo measures temperature from the temporal artery on the user’s forehead. The user simply holds the thermometer next to their head or a child’s head and an array of 16 independent infrared sensors measure the heat being emitted. Readings appear on the side of the device but are also automatically sent to a companion smartphone app, where users can assign them to a particular user and add any other notes.
Sandstone Diagnostics received FDA 510(k) clearance for its Trak system, an app-connected home test for male fertility. Trak’s device aims to disrupt the current model for testing male fertility which is viewed by many as awkward and inconvenient. The device received over-the-counter clearance as a Class 2 medical device. The device itself uses a centrifuge to isolate sperm cells in specially designed cartridges. It then sends results to a smartphone app that will tell the user whether their sperm count is low, moderate, or optimal, based on World Health Organization guidelines. The app not only informs the user of their sperm count, but allows them to compare it to population averages based on aggregated data from users and gives personalized feedback on wellness and lifestyle steps that might help improve their numbers.
Sweden-based Qbtech received an FDA 510(k) clearance for an online tool, called QbCheck, that offers clinical decision-making support for diagnosing and treating children with ADHD.According to the company, the normal route for diagnosing ADHD is complicated, involves, administrative costs, and carries risk for bias. Qbtech’s process aims to make ADHD easier to identify, rule out, and monitor.Reciprocal labs, which runs Propeller Health, received clearance for its Propeller Sensor 2014-R sensor-enabled inhaler and accompanying software.
Medtronic received FDA clearance for its AVIVO Mobile Patient Management System, which continuously measures, records and periodically transmits data for patients with cardiac illnesses. The system uses a wearable sensor and patient-held transmitter that sends information to the Medtronic server.
Salem, New Hampshire-based AgaMatrix got FDA clearance for its wireless blood glucose monitoring system. The device and companion app, called the Jazz Wireless 2 Blood Glucose Monitoring System, was built upon a previously cleared device and can communicate with either both iOS or Android devices via Bluetooth. After taking a reading, the user gets a result in an average of five seconds, which then syncs to the app and can be shared with family and physicians.
Amsterdam-based QServe Group was cleared for its Dyna-Vision Telemonitoring System. The system uses Dyna-Vision devices that monitor cardiovascular health, then transmits data to the system’s server. From there, the data is sent over WiFi or 3G and can be accessed by telemonitoring software and connected smartphone apps.
LifeWatch Technologies received clearance in January for its ECG Mini Continuous ECG Monitor and Arrythmia Detector. Though not smartphone-connected, the single-lead ECG patch transmits data over a cellular connection to a monitoring center. LifeWatch also got an updated clearance in January for its Vital Signs Patch (VSP) which was originally cleared in December 2014. The device is a disposable adhesive strip which contains sensors to monitor ECG, heart rate, respiration rate, temperature, saturation, and movement. It also contains a battery which allows the device to collect data continuously for five to seven days. The system also includes a wireless connected blood pressure cuff and an Android app that processes and transmits the data. The app can also monitor the patient and generate alerts in the event of unusual vital signs. According to a summary document, the update allows the patch to interface with a clinical consult tablet and adds a “Patient Posture Sensor” to the device.
Andon Labs, the parent company of iHealth Labs, got FDA clearance in February for the iHealth Track Blood Pressure Monitor, a new smartphone-connected blood pressure cuff. It’s very similar to a previously-cleared version of the device, according to the summary document. “Only their appearance, the memory capacity, electrical power, measure process, average measure function and the MCU are different, and a new software platform has been added,” the document says.
Shanghai-based Biolight Meditech received clearance in January for a wireless connected thermometer. The battery-powered, handheld device can take temperature orally or under the arm and transmits the data via Bluetooth to an iOS or Android app called Temp Sitter.
TaiDoc Technology, a Taiwanese firm, received FDA clearance in March for a Bluetooth-enabled pulse oximeter. The device is part of a large suite of connected devices for telehealth that TaiDoc offers to providers.Medtronic had two pieces of news around its connected diabetes efforts: an FDA clearance for a hybrid closed loop insulin delivery system and the first test cohort of its Sugar.IQ app, created in collaboration with IBM Watson.The FDA approval of Medtronic’s MiniMed 670G hybrid closed looped system was announced by the FDA itself, as it’s the first automated insulin delivery system to get clearance by the agency.
Medtronic also received a CE Mark for its Guardian Connect mobile continuous glucose monitor (CGM) and app. The company will begin selling the system in select countries in Europe, Asia, and Latin America in Q2 2017 and expects to receive FDA clearance to launch the device in the US around that same time. The Dublin, Ireland-based company already has an FDA and CE cleared connected CGM called Minimed Connect, but that system is for users of both a Medtronic CGM and the company’s insulin pump.
Ascensia Diabetes Care, a new business unit created this year when Panasonic Healthcare Holdings acquired Bayer Diabetes Care, announced the launch and FDA 510(k) clearance of its Contour Next Link blood glucose monitor. Ascensia makes a line of connected and non-connected fingerstick glucometers. The Contour Next Link is a version that sends data wirelessly to Medtronic’s MiniMed 630G insulin pump. According to Ascensia, it’s the only FDA-cleared glucometer that connects to that pump.
Companion Medical, a stealthy San Diego-based company that received funding last year from Eli Lilly and Company, received FDA 510(k) clearance for its Bluetooth-connected smart insulin pen and associated mobile app, called InPen.
“FDA clearance of the InPen and mobile app represents a significant advancement in diabetes care,” CEO Sean Saint, a veteran engineer of Dexcom, Medtronic, and Tandem Diabetes Care, said in a statement. “The product combines the benefits of sophisticated insulin pumps with the simplicity and affordability of pens and syringes, providing patients, physicians, and caregivers increased confidence that diabetes is being managed optimally. We are excited to be the first to introduce this entirely new class of insulin delivery.”
Abbott received FDA Clearance for its FreeStyle Libre Pro system, a key milestone in bringing the company’s unique take on the continuous glucose monitor to the United States. In Europe, where the system has had CE Mark clearance since September 2014, there is both a prescription and over-the-counter version available and the latter is smartphone compatible. The FreeStyle Libre system is notable because it doesn’t require fingersticks to calibrate and it has a lower cost than other CGMs on the market. The user wears a tiny insertable sensor and a patch on their arm for up to 14 days. The patch records glucose data every 15 minutes and uses NFC technology to transmit the data.
Analytica’s PeriCoach, a smartphone-connected Kegel exercise coach for women, received a second FDA 510(k) clearance, one that allows it to be sold over-the-counter. Its previous clearance, from March of last year, was for prescription use only. Analytica is an Australian company and the device, which is also called a pelvic floor exerciser, was already available over the counter in Australia and the UK. It’s cleared to be marketed to eliminate bladder leakage, or Stress Urinary Incontinence, a condition the company says affects one in three women.
AirStrip, which makes a suite of mobile monitoring apps, received FDA 510(k) clearance for a web app version of AirStrip ONE, the company’s mobile interoperability platform. The company also recently received a patent for one of its functionalities within AirStrip ONE, an ECG waveform interpretation that acts as visual calipers for clinicians to make measurements on digital waveforms. Previously, the company has received clearance for its AirStrip Remote Patient Monitoring Solution, and its AirStripOB was one of the very first FDA-cleared medical apps in the AppStore.
Phillips received FDA clearance for an additional transducer for its Lumify ultrasound system, a small portable ultrasound that can connect to mobile devices as well as traditional PACS. The newly cleared S4-1 transducer adds cardiac capabilities to the platform and allows physicians to conduct the focused assessment with sonography for trauma, or FAST exam, with the device.
Redwood City, California-based biotricity, which is working on a biometric remote monitoring solution, received FDA clearance for the software component of their product. The company’s first offering, which is slated for market launch later this year or early next year, is bioflux – a remote cardiac monitoring solution that includes a wearable heart monitor (to be worn on the torso) that uses AT&T’s cellular network to relay data about the wearer’s heart activity to a third-party diagnostic and emergency response team. Bioflux will be given to physicians who want more data about their patients between visits, and the duration and time the device is worn will vary depending on each patient’s particular condition.
Israel-based medical device maker TytoCare received FDA 510(k) clearance for its digital stethoscope, joining the company’s ecosystem of connected tools for remote medical examinations.
Madison, Wisconsin-based Propeller Health, maker of several smart inhaler sensors and companion apps, received FDA 510(k) clearance for a sensor that works with GlaxoSmithKline’s Ellipta inhaler. This marks the company’s eighth FDA clearance, and was born out of a partnership the company struck up with GSK last December. Given Propeller’s growing familiarity with the process, the company said the development-to-clearance timeline was relatively swift.
Senseonics, the Germantown, Maryland-based company which went public in January and is working on a long-term implantable continuous glucose monitor, submitted its PMA application to the FDA, President and CEO Tim Goodnow said on the company’s third quarter earnings call. In addition, the company continues to work on a second generation device and its first pediatric clinical trial.
Ascensia Diabetes Care, a business unit created this year when Panasonic Healthcare Holdings acquired Bayer Diabetes Care, received FDA clearance for a second connected glucometer device, the Contour Next One. Its previous device, the Contour Next Link, was cleared in August.
New York City-based Nanowear received FDA clearance for SimpliECG, a “remote cardiac-monitoring undergarment.” This is the first clearance for the company, which has been in talks with the FDA since 2015, according to a press release.
Paris, France and Cambridge, Massachusetts-based Voluntis, which makes companion software for medical devices or medications, received both FDA clearance and the CE Mark for a type 2 diabetes management app called Insulia.The app, which is designed for people treated with basal insulin, is classified as a prescription-only medical device and will be available to patients and healthcare providers in the first half of 2017.
New York-based One Drop received FDA clearance for its mobile blood glucose monitoring system, One Drop Chrome. The system consists of the Chrome Meter lancing device, test strips and a companion app, and is also now officially available with a monthly subscription service called One Drop Premium. People in the United States, UK and European Union can start ordering the $39.95 subscription service immediately.
Vancouver, BC-based Clarius Mobile Health received FDA 510 (k) clearance for its app-based, wireless, handheld ultrasound scanners. The devices, which are designed for clinicians to quickly conduct scans and guide short procedures at the bedside, are compatible with the latest smartphones and tables both for iOS and Android and are now available for medical professionals on Clarius’s website.
The FDA officially cleared the Dexcom G5 continuous glucose monitor to inform treatment decisions — without the use of a fingerstick glucometer, other than for calibration. The G5 has been cleared for a while to complement a traditional glucometer, but this non-adjunctive clearance is the first of its kind according to Dexcom and the FDA, which both released statements.
The FDA cleared the wireless integration of one of Johnson and Johnson subsidiary LifeScan’s blood glucose monitoring systems and WellDoc’s digital diabetes management platform for people with type 2 diabetes. Using blood glucose data from OneTouch, BlueStar’s platform identifies trends and patterns, sending information to the user’s healthcare team while offering the user individualized feedback in real time. It also offers virtual coaching based on their specific care plan, and the whole system works with the OneTouch Reveal mobile app.
Irvine, California-based Masimo Technologies, which makes non-invasive patient monitoring devices and sensors, received FDA 510(k) clearance for its forehead sensor. The adhesive TFA-1 Forehead Sensor was developed to allow clinicians to monitor patients using pulse oximetry technology from an alternative site instead of a finger.
