FDA Green-lights 14 Digital Health Products, Continues to Evolve Regulations

By MobiHealthNews | July 5, 2018

Interest in digital health is now sprouting up all over DC, from the president’s announcement of a new AI task force to FDA Commissioner’s shout out to digital health in his budget request.

In fact, the FDA is turning to developers in the digital health space to help solve some of the country’s most difficult problems. In May, the agency announced an innovation challenge aimed at tackling the opioid epidemic, where developers could share their approaches to detecting, treating, and preventing addiction.

The agency is also making some new moves when it comes to regulation. Notably, in June the agency ruled that genetic risk tests are officially exempt from requiring 510(K) premarket approval, provided the company offering the test has gone through a one-time premarket review of its testing apparatus and at least one test. The guidance was originally proposed in November 2017.

This comes after years of tension between the agency and players in the space. A high profile example came in 2013 when the FDA ordered 23andme to immediately stop selling its genetic risk testing service because of the lack of evidence to support efficacy of the tests. For a while, the company re-launched without the genetic risk component. But after working with the agency, 23andme got the FDA nod in April of 2017 to sell the direct-to-consumer test kit.

But genetic testing isn’t the only area where the FDA is looking to shake things up. Nearly a year ago the FDA announced plans for its pre-certification pilot program, which would shift the regulatory focus from one particular product to the company and developer of the product. The idea is if the FDA is satisfied that a firm is responsible and safe in its development, then it won’t need to have every product regulated.

In late June the FDA released the second draft of its Pre-Cert frameworks, where it laid out 12 categories that the agency can look at when evaluating an organization. Those areas include leadership, transparency, people and risk management.

This second draft comes after a 17-page first draft was released in April. The first draft spells out two levels of pre-certifications within the software as a medical device (SaMD) space, one for companies with experience developing SaMD and another for businesses developing SaMD for the first time. However, in the latest draft the lines between the two levels are less set in stone; instead companies can test into either category regardless of past experience.

But the drafts are not without critics. Bradley Merrill Thompson, a partner at Epstein Becker Green who specializes in FDA law, said the draft is asking the industry to give the FDA more power and control. Thompson went on to say software that used to fall under enforcement discretion will now be part of the framework and premarket reviews will be more involved.

“This is a good old-fashioned trade,” Thompson said in an email to MobiHealthNews in April after the first draft guidance. “Industry wants faster approvals. FDA wants more control over industry. So FDA’s proposing an exchange: faster approvals for more FDA authority.”

The verdict is still out on the draft guidance and the agency is still taking comments on the draft until July 19.

In addition to the overarching changes the agency is looking to make, it has also cleared or approved 14 digital health products MobiHealthNews has reported on. Here is a list of all of the products that the agency has given the green light to this quarter:

• Early in the quarter smart inhaler company Adherium received a 510(k) clearance for over-the-counter sales of its inhaler monitoring device for AstraZeneca’s Symbicort aerosol inhaler, called the SmartTouch for Symbicort. Adherium makes a device that grafts onto a patient’s inhaler to monitor and encourage medication adherence as part of a self-management plan. It is designed to be easy to install and remove, and includes three buttons that help patients access the audio visual-reminders, battery monitoring, and Bluetooth low-energy pairing features. The inhaler can also help clinicians pinpoint when and how someone is misusing an inhaler, for instance holding it upside down or inhaling at the wrong time.
• In April the FDA granted diagnostics company IDx’s De Novo request to market its AI-based software system for the autonomous detection of diabetic retinopathy in adults who have diabetes, called IDx-DR. This decision marks the first AI-based diagnostic system to be authorized by the FDA for commercialization in the US that can provide a screening decision without the need for clinician interpretation, according to the agency.
• Cerebrovasular imaging company iSchemaView has received the FDA nod for its latest product the RAPID CTA, a 3D imaging platform for computed tomogrpahy angiography (CTA).  CTA scans are used to help clinicians visualize their patients’ cerebral arteries, usually if a patient has experienced a blood clot, according to the company. But interpreting the standard output can be a time-consuming process, it says.
• Cambridge, Massachusetts-based sensor maker MC10, received its first FDA 510(k) clearance for the BioStamp nPoint system. BioStamp nPoint is a more advanced version of the company’s non-FDA cleared BioStampRC. The system consists of reusable adhesive sensor patches that can monitor users for 24 hours at a time. The sensors record vital signs like movement and heart rate and display them on an Android phone also provided by MC10. The system is designed to be used at home or in the clinic.
• New York and Palo Alto, California-based MemoryMD landed FDA clearance for a disposable 19-channel EEG headset, called the NeuroCap. The system is meant to be used with the NeuroEEG, a wireless amplifier worn around the arm that transmits to computers and cloud-based databases via Bluetooth that was approved in February.
• Billerica, Massachusetts-based Insulet Corporation, maker of the OmniPod Insulin pump, scored FDA clearance to commercialize its latest product the Omnipod Dash Insulin Management System. The Omnipod Dash includes a tubeless, wearable insulin pump that can continuously deliver insulin therapy through basal rates and bolus amounts, according to the company’s webpage. The Dash system also includes a handheld Personal Diabetes Manger with a touchscreen, which connects to the pod via Bluetooth technology.
• In June Switzerland-based MindMaze got FDA clearance for the MindMotion Go, a gamified neurorehabilitation therapy platform for medium and light severity impairments able to be deployed in the patient’s home. Using motion capture technology based on the Microsoft Kinect, the Go engages patients with a range of activities set in displayed 3D environments that promote motor and task functions.
• DyAnsys, a medical device company specializing in the autonomic nervous system, announced in mid-June that it has received FDA approval for a wearable auricular neurostimulation device designed to treat symptoms of opioid withdrawal.
• The FDA has granted Isreal-based DreaMed Diabetes a de novo request for its artificial intelligence-powered software for providers managing patients with Type 1 diabetes. The cloud-based DreaMed Advisor Pro is a diabetes treatment decision support product that analyzes data from continuous glucose monitors, insulin pumps, and self-monitoring to determine an insulin delivery recommendation.
• Medical tech company Medtronic landed FDA clearance for its Deep Brain Stimulation (DBS) Clinical Programmer and ActivaProgramming application. The new applications work with DBS systems, which are surgically implanted into a patient’s brain to deliver electrical stimulation to precisely targeted areas of the train, according to a statement. The ActivaProgramming Application was designed to streamline workflows and provide actionable information to neurologists and neurosurgeons who are treating patients using Medtronic’s Activa DBS system.
• Also in Medtronic news, as of late June children with Type 1 diabetes have access to the Medtronic MiniMed 670G, a hybrid closed-loop system insulin delivery system, following the FDA’s decision to expand the product approval for a younger demographic. In 2016 the device became the first FDA-approved continuous glucose monitoring system that controls automated insulin delivery via a hybrid closed loop system. But at that time it was only cleared for patients over the age of 14. This new clearance now opens up the product to kids between the ages of 7 and 14.
• At long last, Eversense, the implantable continuous glucose monitoring system from Senseonics, has received FDA clearance to be marketed in the United States. The company has been waiting on this clearance since November 2016. It’s very significant for the company, which is already selling its second-generation device in Europe, the Middle East, and Africa.
• The FDA granted connected health company Fresca Medical De Novo authorization to market its Curve device, a positive airway pressure delivery system that treats obstructive sleep apnea. The Curve includes a flow generator, a lightweight and ergonomic air delivery hose, and a nasal pillow. The company said the device is different from typical CPAPs because of its SmartValve technology, which it noted uses less airflow than other systems and could lead to higher rates of adherence for those with sleep apnea.