Fifty-one connected health products the FDA cleared in 2017

By MobiHealthNews
02:00 pm

In 2017, MobiHealthNews covered 51 devices that received clearance from the FDA. Along with a handful of diagnostic devices, disease management platforms, and novel monitors, this year boasted a few surprises from the agency, such as the approval of a direct-to-consumer genetic tests for disease risk and a purely digital intervention. The year also hosted its fair share of regulatory news and shakeups, which we’ve summarized here.

Read on for MobiHealthNews’ 51 FDA clearances of 2017.

Medtronic received FDA 510(k) clearance for its sensor-enabled vest — a single-use, disposable wearable called the CardioInsight Noninvasive 3D Mapping System. The vest features 252 electrode sensors to provide a wide range of electroanatomic 3D maps of the upper and lower chambers of the heart, and works by pairing body surface electrocardiogram (ECG) signals from the chest, then combining them with data from a computed tomography (CT) scan of the heart and connecting to the CardioInsight Workstation. It comes in four sizes, contouring to the wearer’s body and enabling continuous, simultaneous panoramic mapping of both atria or both ventricles (which can’t be done with the catheter method). More

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San Diego, California-based ResMed received FDA 510(k) clearance for its small, portable continuous positive airway pressure (CPAP) device, the AirMini. Designed to be used as an secondary device — particularly during travel or any other time the user doesn’t have access to or doesn’t want to bring their full-size CPAP device along — the AirMini is ResMed’s first FDA-cleared device. The device comes in a case about the same size as one used to carry sunglasses. More

The US Food and Drug Administration gave the green light for a non-prescription version of BlueStar, WellDoc’s mobile diabetes management platform.Through this 510(k) class II clearance, WellDoc can offer BlueStar and BlueStar Rx, allowing the company to offer the product through more channels. Both versions analyze diabetes data entered by the patient, comparing past data trends to form personalized guidance and creating a summary of curated data analytics to the healthcare team for clinical decision support, but the non-prescription version does not feature the insulin calculator that the full version does. More

Indianapolis-based pharma company Eli Lilly recieved FDA 510K clearance for a new mobile app called Go Dose, a diabetes management and insulin dosing app for users of Humalog, Lilly's rapid-acting insulin. The clearance is for prescription use, but includes two versions of the app: Go Dose, for patients, and Go Dose Pro, for healthcare providers. More

UK-based cognitive assessment company Cambridge Cognition received FDA clearance for Cantab Mobile, the company's iPad-based assessment tool for memory issues in older adults that previously had acquired a CE Mark. Cantab Mobile is a 10-minute test — based on the Pairs Associates Learning or PAL test — administered via a tablet that puts the user through three different exercises to test their memory. It's meant to serve as an early warning system for conditions like dementia and Alzheimer's. It also builds in a test for depression, allowing the test to distinguish between mood disorders and memory impairment. More

VivaLnk, a Santa Clara-based connected health startup, received FDA clearance for its first device, a peel-and-stick continuous thermometer for children called Fever Scout. VivaLnk announced Fever Scout at CES 2015 and originally planned to launch it that year, but delayed the launch more than once. FDA clearance could mean the device will finally come to market. More

Medical device maker Zoll Medical Corporation received FDA premarket approval for a wearable external defibrillator for use in the hospital. Zoll got approval back in 2001 for its LifeVest, a similar product designed for home use. The system monitors the user's heart rhythm for signs of ventricular tachycardia or ventricular fibrillation. If it detects an irregularity, it performs a check to see if the wearer is conscious, giving them a chance to cancel the process if they are. If the wearer doesn't respond in a minute, the system delivers a shock. If the first shock doesn't return the heart rhythm to normal, it will administer another. More

Following in the footsteps of Eli Lilly and Roche, Sanofi quietly received FDA clearance for a smartphone app with a built-in insulin dose calculator. According to FDA documents, the app, cleared at the end of March, is called My Dose Coach. A pending trademark application gives a more in-depth description of the app, describing it as "downloadable software in the nature of a mobile application for use by patients with diabetes, for calculating and monitoring insulin dosages." The trademark application also suggests the app will contain some kind of database of diabetes information. It’s one of a small number of FDA-cleared insulin dosage calculator apps. More

Madison, Wisconsin-based EnsoData received FDA clearance for its sleep analysis software called EnsoSleep, which uses machine learning to analyze sleep quality and aide in diagnosis of sleep or respiratory-related sleep disorders. It’s intended to reduce the time it takes to analyze a sleep study by interfacing with polysomnography systems and intelligently automating, analyzing and generating a report of sleep data. The software integrates with existing lab workflows to detect sleep staging, sleep-disordered breathing, apneas, and leg movements. More

Chinese medical supply company Shenzen-Kingyield has received FDA 510(k) clearance for a Bluetooth-connected blood pressure monitor. The device is worn on the wrist and sends data to a smartphone for archiving or analysis, according to the clearance document, and the device has been cleared for over the counter sales. The company makes a variety of blood pressure monitors, blood glucose monitors, infrared thermometers, pulse oximeters, and nebulizers that it sells to hospitals and other enterprise customers. More

Cardiac Insight, a Kirkland, Washington-based company that makes a portable, Bluetooth-connected ECG device for athletes, received an FDA clearance for the Stealth System S300, a prescription-only continuous ECG recorder that can be worn for seven days. The device appears similar to (and in fact lists as a predicate device) iRhythm's ZIO patch. Like the ZIO patch — and unlike Cardiac Insight's existing CardeaScreen device — the Stealth System isn't wirelessly connected: the data has to be manually downloaded via a cable after the patient finishes wearing it. Nevertheless, both devices provide a significant improvement over Holter monitoring in terms of cost and ease of use. More

Intuity Medical, the diabetes management technology company that closed a $55 million funding round in January, received clearance for a software update to its Pogo blood glucose monitor. Pogo received FDA clearance in April 2016, and consists of a test port, lancets and lancing device in one compact meter and cartridge system, which allows users to quickly perform a glucose test discreetly in public settings or when they are pressed for time. More

Rochester, New York based medical imaging company CareStream received 510(k) clearance for SmartGrid, a new feature that will be added to its DirectView DR software. SmartGrid is an algorithm that cleans up certain kinds of noise on particular radiological images. The feature "is designed to improve contrast and reduce the appearance of scatter in radiographic images that have been acquired without a physical grid" according to clearance documents, which also explain that the clearance includes "an algorithm for estimating and removing scatter from radiographic images." More

Swiss neurogaming company MindMaze has received FDA clearance for its MindMotion Pro platform, a motion capture system similar to the Microsoft Kinect which can be used in rehabilitation of stroke and traumatic injury patients. It’s designed for use in the hospital as soon as patients start their rehabilitation. For stroke victims who have lost the use of the left hand but retain the use of the right, for instance, the computer will project a virtual reality depiction of the nonfunctional left hand, which is controlled by the patient's movement of the working right hand. This can trick the brain into kickstarting the functionality of the other hand. More

The FDA granted a second 510(k) clearance in May to CareTaker, a Charlottesville, Virginia connected medical device company. CareTaker's device of the same name is a wearable, connected blood pressure and heart rate sensor that originally received clearance in spring 2016. CareTaker is worn on the wrist with a cuff that's looped over the index finger. The device measures blood pressure and heart rate continuously and sends the data to an Android phone or tablet, or directly to a hospital via cellular networks. The device can also be used as a wearable hub for collecting and displaying, on the tablet screen, data from other connected devices, including glucometers, weight scales, thermometers, and spirometers. The newest clearance allows the device to be used without first being calibrated with a traditional upper arm blood pressure cuff. More

Dublin, Ohio-based Monitored Therapeutics, Inc. (MTI) received FDA 510(k) clearance for its connected spirometer, GoSpiro. The device, which calculates diagnostic-quality air capacity measurement, was designed specifically for use in a non-clinical setting. As calculations are performed inside the device, GoSpiro can work with any smartphone, tablet, or computer without the need for separate FDA submissions. GoSpiro has been clinically-validated to measure lung function quality in the patient’s home with accuracy levels as robust as hospital and laboratory systems. More

Ashkelon, Israel-based Oxitone Medical has received FDA clearance for a wristworn pulse oximeter that doesn't require a finger clip. According to the company, the device — the Oxitone 1000 — can pick up SpO2 and pulse rate with the same accuracy as traditional fingertip pulse oximeters. Despite the consumer-friendly form factor, Oxitone is targeting the clinical market; the design of the wearable is an adherence play, as the company hopes that a more comfortable device will be worn more consistently by home monitoring patients than a bulky fingertip unit. Measuring from the wrist also allows patients' blood oxygenation to be monitored while they participate more naturally in everyday activities. More

Dexcom's Share app, which allows users to view and share data from their G5 continuous glucose monitors, is now available for Android users after receiving its FDA clearance in June. The launch is a long time coming, as iOS users have had access to the app since 2015. Regulated Android apps can be slower to market because, unlike iOS apps, they have to work on a wide range of devices from different manufacturers. Additionally, Dexcom has said in the past that the Bluetooth LE technology Dexcom Share uses wasn't available for Android at the time the app was originally developed. More

Berkeley, California-based Eko Devices received FDA clearance for Duo, a smart heart monitor that is a combination of a digital stethoscope and portable electrocardiogram. Duo is intended as a prescription-only screening tool as part of an at-home monitoring plan, and it works with a companion app for remote monitoring or diagnosis. The idea is to keep continuous tabs on patients at risk for heart failure rather than relying on in-office visits that are inadequate in monitoring such complex medical conditions. More

In a true first, the FDA is allowing 23andMe to sell its direct-to-consumer genetic test kits that provide information about an individual’s risk to certain diseases such as Alzheimer’s or Parkinson’s disease. 23andMe’s $199 genetic tests are available with the FDA’s blessing nearly three and a half years after the agency first ordered 23andMe to immediately stop selling its testing service for genetic risks, citing a lack of evidence to support the efficacy of tests (although the company was allowed to continue selling the popular ancestry tests it has offered since 2007). That led 23andMe to re-launch a toned-down version in late 2015, which gave consumers reports about their “carrier status” of certain conditions but not a genetic health risk. In the meantime, they didn’t avoid the FDA, but doubled down on their clinical validation to finally land the agency’s approval. More

San Diego-based Clarify Medical received FDA 510(k) clearance for its core technology, a handheld, smartphone-connected phototherapy device for treating various skin conditions. The device can deliver narrow-band ultraviolet light, a treatment that has been studied and proven effective for certain skin conditions. Users need to have a prescription from their doctor to use the device, and the technology can connect a patient to their doctor, allowing the doctor to follow treatment progress as well as set a treatment schedule for the patient. More

Nanobiosym, the Cambridge, Massachusetts-based digital health company whose Gene-RADAR scanner won the Nokia Sensing X Prize a few years ago, was granted Emergency Use Authorization from the FDA for its Zika Virus Test in April. EUA is a special clearance pathway the FDA uses for devices that address an immediate public health crisis like Zika. Devices authorized under EUA aren’t cleared or approved and can only be used to address the crisis at hand. While FDA has cleared a number of Zika tests under EUA previously, Gene-RADAR has several advantages over the others: The device is small and can be used onsite at a hospital, rather than doctors having to ship samples to a lab to be tested by a much larger device. The device also has less of a false positive problem than antigen/antibody tests, another kind of assay that’s been cleared. More

In an FDA first, Boston- and San Francisco-based Pear Therapeutics' reSET system for the treatment of substance abuse has been granted a de novo clearance by the agency. It's the first software-only digital therapeutic the FDA has cleared with claims to improve clinical outcomes in a disease. reSET is a 12-week program designed to treat addiction and dependency on stimulants, cannabis, cocaine, and alcohol. The system is not usable for opioids. More

A month later, Pear Therapeutics also announced that reSET-O, a digital therapeutic for opioid use disorder, had received an Expedited Access Pathway (EAP) designation from the FDA. Interventions and assessment tools are provided to the patient via a mobile app, and the data collected is delivered to a clinician dashboard. The EAP designation doesn't mean that the FDA has cleared the product, only that it has committed to fast-tracking it through the clearance process because of its timely public health value. More

Abbott Diabetes Care's Freestyle Libre Flash Glucose Monitoring System was granted FDA clearance. As well as finally bringing the system, which is already available in 39 other countries, home to the US where Abbott is based, the clearance also represents a first for continuous glucose monitoring, as it doesn't require the user to use a fingerstick, even for calibration. More

Global digital health outfit DarioHealth Corp., which emphasizes mobile health and data solutions, has been granted 510(k) clearance for the Dario app on certain Android mobile devices by the U.S. Food and Drug Administration. Dario’s primary device is a glucose meter that is small enough to fit in someone’s pocket. The newly cleared companion app, available on iOS and Android devices, syncs with the glucose meter and 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. More

Cochlear Limited, which creates implantable hearing devices, has taken a technological leap forward with a device that syncs up with various Apple products. The Nucleus 7 Sound Processor, which was approved by the FDA in June, is the first cochlear implant sound solution made specifically for use with iPhones, iPods and iPads; it also has the distinction of being the smallest and lightest behind-the-ear cochlear implant currently on the market. More

Dictum Health, which makes an end-to-end telehealth platform, receieved clearance to add spirometry to the capabilities of its "virtual exam room," which can already handle Sp02, blood pressure, height and weight, temperature, and ECG. The device takes the form of a tablet that connects to a variety of health device peripherals and it is cleared for use both in hospitals and in the home. Through the tablet, patients and doctors can conduct a secure, HIPAA-compliant video visit and beam vitals data directly to the clinician. More

Philips received an additional FDA clearance for eCareCoordinator, a telehealth application that was originally cleared in October 2014. With eCareCoordinator, clinicians can access daily summaries for each patient so that they can prioritize which patients to reach out to and what care plans they need to adjust. The app collects data from connected devices that measure health metrics including blood pressure, vital signs, and weight, but the app also gathers more subjective data from questionnaires and communication with the patient's care team. More

Osprey Medical’s DyeVert system — which helps reduce the risk of kidney damage to patients undergoing certain surgeries, including angiograms, stent placements, balloon angioplasties — uses a Bluetooth-equipped smart syringe and an associated monitor to track exactly how much dye is being used and halt the injection at a threshhold that could potentially harm the patient. While the whole system was cleared in March, Osprey received another clearance for the needle alone in July. More

Milestone Scientific has developed a technology that will be used for epidural procedures, and allows anesthesiologists and other clinicians the ability to determine the pressure at the tip of a needle in real-time. The newly cleared epidural instrument uses a new innovation to drug delivery called Dynamic Pressure Sensing, the same technology used by Milestone Scientific’s dental instrument, the Wand STA. If widely adopted, the technology has the potential to reduce procedural risks to patients, and perhaps even reduce the malpractice risks to medical professionals administering epidurals. More

Diabetes therapy management software company Glytec secured its fourth FDA clearance, adding a slew of capabilities to its Glucommander product, the core of its eGlycemic Management System. This latest FDA clearance incorporates some of the product enhancements that have been suggested by the company’s user community, including a titration module designed expressly for inpatients receiving enteral nutrition. Other enhancements include an insulin-to-carb ratio titration option for outpatients, which complements the existing fixed meal bolus option; a more streamlined transition of inpatients from intravenous to subcutaneous therapy; greater flexibility in messaging of a dose adjustment for outpatients; and some interface and workflow tweaks. More

NxStage Medical, a medical technology outfit focused on advancing renal care, has received clearance from the FDA for its System One, which allows for solo home hemodialysis, without a care partner, during waking hours. Previous iterations of the hemodialysis device required a care partner to be present with the patient. More

Melbourne, Australia-based Adherium, a digital health company that focuses in improving medication adherence and patient outcomes, received FDA clearance for a new inhaler monitoring device for AstraZeneca’s Symbicort aerosol inhaler, dubbed the SmartTouch for Symbicort. The SmartTouch is a device that grafts onto a patient’s inhaler to monitor and encourage medication adherence as part of a self-management plan. It’s the latest product in Adherium’s product portfolio, and is geared toward respiratory patients who deal with ailments such as asthma and COPD. More

Medtronic has received FDA clearance for a new implantable pain management device that can be programmed wirelessly via a Samsung tablet. The Intellis system is designed to treat chronic pain by delivering neurostimulation at the spinal cord. Using a Samsung Galaxy Tab S2, the patient's caregiver can adjust the neurostimulation according to a workflow designed by Medtronic called Evolve. More

NimbleHeart, the Campell, California-based producer of clinical-grade mobile cardiac monitoring devices, announced that its fully reusable ECG device has received FDA clearance and will soon be brought to market. The Physiotrace Smart wraps around a user's torso, and is used without electrolytic gels or adhesives. It can be cleaned and disinfected easily by wiping with water and alcohol, thereby making it ideal for multi-patient use. More

Redwood City, California-based Carrot has received FDA 510(k) clearance for its Carbon Monoxide Breath Sensor System, an over-the-counter, Bluetooth-enabled device that pairs with a smartphone app and is intended for commercial use in smoking cessation programs. Carrot’s device is intended for a single user to monitor their breath carbon monoxide levels and see how these are affected by their smoking behaviors. The device works alongside Carrot’s newly launched medical mobile app for smoking cessation, Pivot. More

New York City and Guilford, Connecticut-based Butterfly IQ has received FDA clearance for an iPhone-connected portable ultrasound scanner that uses an easy-to-manufacture semiconductor chip rather than the piezoelectric crystals used by traditional ultrasounds. The device is cleared for 13 different clinical use cases, including fetal, abdominal, cardiac, gynecological, urological, and pediatric use cases. It transfers the imagery directly to a user's iPhone via a cord and stores images in a HIPAA-compliant cloud. More

Abilify MyCite has been approved by the FDA as the first drug in the US with a digital ingestion tracking system. The pill, Abilify MyCite, is prescribed for treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and as an add-on treatment for depression in adults. An ingestible sensor embedded in the pill is able to record that the medication was taken – sending signals to a wearable patch that then transmits the data to a mobile app. This allows patients to track their meds on their smartphone; it also enables caregivers and physicians to access adherence data through a web-based portal, when given permission by the patient. More

EndoVantages’ SurgicalPreview — a cloud-based computer modeling platform that lets surgeons upload individual patient’s CT scans and then creates a 3D model of the brain with anatomical measurements — had been cleared by the FDA. The new tool is designed to help doctors pre-plan endovascular treatment. It enables clinicians to view stent strategies, calculate aneurysmal volume and neck size and view stent delivery and placement. More

Medical device software company Voluntis has received an updated FDA clearance (as well as an updated CE mark) for its Insulia app, a "digital companion" app for people with Type 2 diabetes. Insulia offers realtime basal insulin dose coaching, and the new clearance makes the app usable with two additional brands of insulin: Basaglar and Tresiba. The app had already worked for users of Lantus, Levemir, and Toujeo. More

The FDA has cleared a second generation of Qualcomm Life’s Capsule Vitals Plus, a connected monitoring product. The product records medical device data and continuous vital signs monitoring. It then analyzes the information at the patient's bedside. Different from the first generation of the product, vital plus now supports automatic intervals for non-invasive blood pressure measurements, continuous Sp02 monitoring and physiological alarms. The first generation of the product is upgradeable to the second. More

St. Jude Medical, a subsidiary of Abbott as of this past January, recieved a new FDA clearance for the MyMerlin companion app to its Confirm Rx Insertible Cardiac Monitor, which was cleared in late September. The device automatically sends data to the app which, in turn, sends data to the user's care provider at regular intervals. Patients can also record symptoms in the app and manually send a recording to their physician. More

Park City, Utah-based Cardiac Designs has received clearance for two new updated devices, ECG Check Universal and ECG Check Universal Plus. One update is that ECG Check was only for iPhone, while both new devices can run on Android as well. In order to accomodate different sizes of phones, the device has also been redesigned to be a standalone device rather than a phone case. The company has also added a rechargeable battery, rather than a replaceable battery like the original model had. Finally, the Universal Plus will have the ability to transmit ECG readings on an analog phone line (in addition to the cellular transmission option), and will have a button that can be used to send stored files to a provider or to delete all stored recordings. More

Tapei, Taiwan-based Rooti Labs received its first FDA clearance for its wearable continuous ECG monitor, RootiCare, and the RootiLink app that allows users to transmit the readings from the device via wifi. The portable monitor uses a single-lead ECG sensor to achieve a simple and accurate recording of a patient's vital signs for up to 7 days. More

Cardiomedix received clearance for ECG Sentinel, an ECG device that monitors the user and sends data to their provider via a smartphone. The clearance document describes it as a “self-use, 2-lead ECG continuous acquisition and transmission system” that “connects via Bluetooth to a proprietary mobile phone-based, dedicated ECG acquisition, storage, and transmission application.” More

The FDA has cleared Abbott’s Confirm Rx Insertable Cardiac Monitor (ICM), an implantable device that continuously tracks patients’ heart rhythms and sends the data to a smartphone app via Bluetooth. The device is placed just under the skin of the chest in a minimally-invasive outpatient procedure. Encrypted data from the device is coordinated by the myMerlin mobile app, then sent from the patient’s phone to a physician at predetermined intervals. With the clearance, Abbott will soon be rolling out the device in the US. More

London-based medical device manufacturer LivaNovahas announced FDA approval of its most recent Vagus Nerve Stimulation Therapy (VNS Therapy) System, which will be the smallest and lightest responsive therapy available for drug-resistant epilepsy patients aged four years and older. The treatment consists of the new SenTiva implantable generator, the VNS Therapy Programming System, a wireless wand, and a new smart tablet-based user interface. More

New York-based Peerbridge Health announced that its wireless device, dubbed the Peerbridge Cor System, is the latest ECG device to receive 510(k) clearance from the FDA. According to the company, the device has the smaller on-body footprint of any wearable, multi-channel ECG with water-resistant electrodes. The Peerbridge Cor can be worn for as many as seven days, and included a patient-activated event logging feature as well as a dedicated handheld transmitter for event transmission. More

The FDA has approved hearing implant maker Cochlear Limited’s submission for a new remote feature that would allow specialists to perform follow-up programming on a patient’s cochlear implant remotely, a la a telemedicine platform. The feature for the company’s Nucleus Cochlear Implant System is indicated for those who have had at least six months of experience with their implant sound processor, and according to the FDA could serve as a substantial relief to certain hearing loss patients. More

Disposable vitals sensor maker VitalConnect has received a new FDA clearance, lengthening the life of its VitalPatch device from four days to five. VitalPatch is an FDA-cleared, disposable peel-and-stick health sensor, which continuously monitors eight different vitals (ECG, heart rate, heart rate variability, respiratory rate, skin temperature, posture, and steps, as well as automatic fall detection) in real-time. More


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