HealthTech innovations : FDA clearances so far in 2016

Source : MobiHealthNews



Comment :  ++  interesting overview about HealthTech innovations

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-Rsensor-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.

2Q Venture Capital Report : Rock Health, CB Insights count $2B, $3.5B respectively for 2016 health funding

Source : RockHealth, KPMG, CBInsights

BB Comments : In a year when everyone expected funding to decline, digital health has been as steady as ever and accounted for a healthy 8% of total venture funding. Beside that the first half of 2016 came out with a record-breaking 151 companies which raised more than $2M.

As we come to the midyear point of digital health funding, two reports from Rock Health and CB Insights / KPMG offer up analysis of how 2016 is coming along.



Rock Health reported just more than $2 billion in total venture funding – on track with the levels of both 2014 and 2015. While funding hasn’t continued to surge upwards as it has in the past, Rock Health analysts Mitchell Mom and Ashlee Adams write digital health funding is "hitting its stride."

Following two record years of digital health funding, they report, 2016 has started with a more moderate pace, with overall funding about $191 million below 2015’s first half record.

"While this number ($2B) didn’t eclipse either of the previous years’ numbers, it’s important to keep context," they write. "In a year when everyone expected funding to decline, digital health has been as steady as ever and accounted for a healthy 8 percent of total venture funding."

CB Insights, which is newer than Rock Health and tracks a much broader range of digital health companies, reported $3.5 billion in funding across 476 deals. Both noted a leveling off of funding in Q2. Both also track the top geographic region for funding as California, followed by New York.

As we’ve written before, it’s important to note that, generally, Rock Health’s process is a bit more conservative than most, as it only includes funding rounds that are more than $2 million, avoids conflating investment dollars with transactional costs associated with M&A, and has a stricter definition of a digital health company than either CB Insights or StartUp Health, whose midyear funding we reported earlier this month.

While the dollars might be leveling off, the sheer number of companies receiving funding at an all-time high, Rock Health reports, with 151 companies raising more than $2 million.

Rock Health reports the average deal size for 2016 at $13.3 million. While the first quarter saw larger rounds (deals averaging at $15.4 million), the leveling off during Q2 brought the overall midyear average down quite a few pegs. The largest deal thus far has been Flatiron Health, in a $175 million round led by Roche.

The top six categories of the year that received 54 percent of all funding were analytics/big data with over $300 million in funding (Flatiron alone accounted for more than half of that with $175 million); wearables and biosensing at $217 million (Jawbone making up $165 million of that); population health and management at $184 million; personal health tools at $132 million; EHR/clinical workflow at $127 million; and digital health devices with $122 million.

Rock Health noted that the consumer space also continues to receive consistent investor attention, with two of the top three digital health "unicorns" -- 23andMe and ZocDoc -- being consumer-focused companies. Rock Health sees consumerazition as an area ripe for "disruption by digital health startups," thanks to the fact that over one-third of adults are now convered under high deductible health plans, a shift in coverage that transfers more of the burden to the consumer. While healthcare consumer engagement still didn’t make the top six, it did experience year-over-year growth of 127 percent.

Two hundred and forty-eight distinct investors funded digital health companies in 2016, according to Rock Health’s definition. Most active venture investors for 2016 have been a mix of new and old, with corporate investors outpacing traditional venture funds in the number of deals. Top venture investors were Khosla Ventures, Jump Capital, Norwest Venture Partners, Pritzer Group, Safeguard Scientifics and Jump Capital. UPMC, Heritage Group, Blue Cross Blue Shield and Merck topped out the corporate most-active list.

As has been the trend for the past two years, Seed and Series A stage deals represent most of the deal volume, and later stage deals account for a little more than a fifth of all deals.

Looking at exits, Rock Health reported 2016 has also been slower in public markets than previous years, with NantHealth's $1.5 billion offering accounting for the only IPO. Overall, IPO performance hasn’t kept pace with funding, with nearly all public companies trading below their initial share price.

Halfway through the year, 87 mergers and acquisition deals have already been closed (slightly below 2015’s midyear mark), with total disclosed dollars eclipsing $10 billion.

As Rock Health analysts say, "Stay tuned to find out if this year will become the new normal or if we’re still waiting for the proverbial shoe to drop."

#eHealthMarktets: #eHealthM&A : Jawbone acquires Spectros

Jawbone acquires Spectros: While this acquisition quietly took place last year, MobiHealthNews broke the news in June: Jawbone secretly acquired a medical sensor company called Spectros and appointed its founder as their new Chief Medical Officer. The move gives weight to rumors that the struggling wearables company is shifting its focus to regulated medical device wearables. Spectros, an 11-year-old company with at least six patents and numerous published studies, specialized in using spectroscopy to create a range of non-invasive molecular sensors. In particular, commercial applications of the technology used it for pulse oximetry, and detection of perfusion and ischemia. The company's On-Call remote monitoring product allowed doctors to monitor their patients using a smartphone.