Roundup: FDA digital health clearances and news in Q3 2017

By MobiHealthNews
10:00 am

Led by a new commissioner in Dr. Scott Gottlieb, the FDA had a busy few months with a handful of digital and mobile technologies getting cleared in the third quarter of 2017. Consumer-focused diabetes and pain management offerings were prominent, but but by and large the clearances hit a multitude of clinical concerns and, of note, even included the first software-only digital therapeutic.

Outside of reviewing devices, the FDA announced a new digital health pre-certification program pilot focused not on particular products, but on assisting firms and developers. Just months after announcing and opening the program up to applicants, the agency quickly settled on the nine companies that will be participating in its new, firm-focused digital health pre-certification program pilot. The list includes major tech companies Apple and Samsung; health tech companies Verily, Pear Therapeutics, Tidepool, and Phosphorus; pharmaceutical companies Roche and Johnson & Johnson; and Fitbit — an interesting inclusion insofaras the most of the company's offerings are not FDA-cleared.

In a blog post, the agency also revealed the upcoming inaugural meeting of its recently announced Patient Education Advisory Committee, as well as the nine core voting members of said committee. The full list — which includes industry players, patient advocates, academics, and professional society heads — can be found here.

The FDA even had a chance to flex its muscles this July, when it sent a warning letter to Boston-based eye tracking company SyncThink objecting to the labeling of their EYE-SYNC device. According to the letter, the company suggested that the device was intended for cognitive assessment and testing of concussions and head trauma, for which it lacked FDA approval. In the months following receipt of the letter, SyncThink made major changes to its marketing materials reflecting the agency’s concerns

As for the clearances, here are the companies whose devices received an FDA nod in the third quarter of 2017:

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

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 this 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


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