Round-up: FDA clearances so far in 2016

By Heather Mack
07:06 pm

We’ve compiled a list of our FDA-related coverage for first half of 2016. Eighteen companies received clearance for their devices, one was declined, and one group of patients published an editorial about their relationship with the FDA. Also this year, the FDA came out with some new guidance about how medical device makers should make data available to patients.

Read on for our roundup of clearances and other FDA news, including some 510(k)s we missed the first time around.
FDA clearances roundup

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 transmit 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 consul 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.

Other FDA-related news

In early June that the FDA offered up a draft guidance document to help medical device makers better understand how the agency thinks about patient access to data. While the FDA's guidance document encourages device makers to share data with patients, it also suggests these companies take into consideration the best way to share this information "to ensure it is useable by patients and to avoid the disclosure of confusing or unclear information that could be misinterpreted."

As their famous rallying cry states, the patients behind the Nightscout project for creating a do-it-yourself mobile technology for diabetes management are not waiting for approval from the FDA. But that doesn't mean they aren't seeking it, or that they haven't been in contact with the regulatory organization to make sure Nightscout is as safe as it can be. In an editorial published in the Journal of the American Medical Association, Dr. Joyce Lee and Emily Hirschfield of the University of Michigan, as well as Nightscout Foundation President James Wedding, wrote about some of the triumphs and challenges the now-two-year-old patient-led initiative has faced.

In late April the FDA declined to approve what would have been the first mass market drug to incorporate Proteus Digital Health's ingestible sensor. The drug, a collaboration between Proteus and Otsuka Pharmaceuticals, combines the Proteus system with the antipsychotic pharmaceutical Abilify.Proteus and Otsuka submitted the system as a new drug application (NDA) in September 2015. Because both halves of the system are already cleared or approved by the FDA, the companies expected a swift approval. Instead, they were issued a Complete Response Letter (CRL), a non-public document issued by the FDA that lays out the additional steps a non-approved drug must take to secure approval. 

Smartphone-based eye exams, the province of a growing number of digital health startups, caught the attention of the American Optometric Association this quarter. The AOA penned a letter to the FDA asking that the agency impose stricter guidance on Opternative, a smartphone-based eye exam startup that raised $6 million earlier this year. Opternative is registered with the FDA as a Class 1 device, which do not require pre-market approval. CEO Aaron Dallek told MobiHealthNews in February that the technology is robust and validated.


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