A closer look at the FDA's moves, clearances in the second half of 2019

This half of the year the FDA has named a new comissioner, continued working on the much anticipated Pre-Cert program and collaborated with the NIH on a new app.
By Dave Muoio and Laura Lovett
09:13 am
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The back half of 2019 saw an FDA in the midst of a transition — both in terms of personnel and in digital regulation strategy. 

On the former, the agency seems to finally be regaining its legs since the unexpected March resignation of its former head, Dr. Scott Gottlieb. After a rotating door of acting commissioners — consisting of Dr. Ned Sharpless from the National Cancer Institute and more recently Brett Giroir from Health and Human Services — Dr. Stephen Hahn was confirmed by a 72-18 US Senate vote to lead the agency. 

Hahn, an oncologist from Texas, previously served as the chief medical executive at MD Anderson Cancer Center in Houston, a post he has held since 2018, and had served as head of the radiation oncology division since 2015.

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And while many eyes will be on high-profile health issues such as underage vaping and the opioid epidemic, those with an interest in digital health will be keen to see the agency’s ongoing efforts to revamp the regulation of these novel products.

Take, for instance, the FDA’s Pre-Cert Program. Early in the second half of 2019 the agency released a Mid-Year Update of the program’s Working Model one-year pilot. At the time, the agency reported that its retrospective testing of the original nine pilot participants was complete and that prospective testing was in progress. Not too long afterward, pilot participant Pear Therapeutics announced that Somryst, its experimental digital treatment for chronic insomnia and depression, would be the first software as a medical device product to be submitted for marketing approval through the novel pathway.

The FDA is still on the hook for an end-of-year update on the pilot program’s progress, but the past couple of months have had certain onlookers questioning Pre-Cert’s unique approach to regulation. At the end of October, Senators Elizabeth Warren, Patty Murray and Tina Smith penned an open letter to the agency expressing concern over the program’s potential impact on public safety. Some of these points were echoed in an op-ed by regulatory law expert and industry spokesperson Bradley Merrill Thompson, who also worried that precertification would come at the detriment of a lively startup environment. 

But Pre-Cert is far from the agency’s only regulatory changeup that’s set to impact digital health. Late September also hosted the release of new draft guidance outlining categories of clinical decision support (CDS) products that would or would not require direct regulatory oversight from the agency. This is an update to a CDS draft guidance released in 2017, with the noteworthy addition of a risk-based categorization approach for determining enforcement over these tools.

Alongside the draft also came a final guidance bringing several existing medical software policies from the agency in line with provisions outlined in 2016’s 21st Century Cures Act. In particular, the document describes certain types of software products that will no longer fall within the agency’s definition of a medical device. These include software for health care facility administration, electronic paper records and, notably for digital health, apps designed to encourage health and wellness.

And speaking of software, the FDA put out a new app alongside the NIH just a few weeks ago. Called CURE ID, the online data repository allows clinicians to report instances in which existing FDA-approved drugs are used to successfully treat infections. In particular, the tool captures clinical outcomes in cases when these drugs “are used for new indications, in new populations, in new doses or in new combinations,” creating a new source of real-word data which the agency said will help identify candidates for new clinical studies.

All the while, the FDA maintained its role as an industry watchdog, issuing a handful of device recalls and dozens of clearances for digital health products during the last six months. The recalls included the sixth cumulative recall of Roche’s Accu-Chek, a recall of Visibly (after years of back and forth with the company), and a recall of Senseonics’ Eversense continuous glucose monitoring system due to a malfunctioning sensor. 

As for the clearances, see the list below for links to our coverage of 12 digital health products green lit by the FDA in the second half of 2019.

FDA Clearances from H2 2019

In July, Teva Pharmaceutical Industries announced that the FDA cleared its AirDuo Digihaler, a sensor-enabled inhaler. The product, classified as a maintenance asthma inhaler, has a built-in sensor that sends usage data to a corresponding app on a user's smartphone. This information can also be sent to the user’s provider. 


Later that month, PhysIQ announced that it landed 510(k) clearance for an algorithm facilitating cloud-based analysis of patients’ continuous ambulatory respiration rates. PhysIQ’s algorithms are capable of extracting these raw readings from a variety of monitoring hardware, and then centralizing the output within a single platform.


Paris, France-based Voluntis received FDA marketing authorization for an algorithm-driven digital tool that helps cancer patients manage their symptoms and care teams identify clinical insights. The Oleena software is a Class II medical device that is prescribed by the patient’s care team. As the user logs their symptoms into the app, it adapts to offer personalized guidance on how each patient can self-manage their condition. 


Tel Aviv, Israel-based Biobeat was granted 510(k) clearance for a remote monitoring device capable of measuring the wearer’s blood pressure, oxygenation and heart rate.

Designed for use in the hospital or at home, the device is available as either a wristwatch or adhesive patch. Of particular note, the products differentiate themselves from other remote monitoring devices through a photoplethysmography (PPG) approach that sidesteps the need for an inflatable cuff.


In September Healthy.io announced that it received a second FDA 510(k) clearance intended to support diagnosis of chronic kidney diseases. The product is is an albumin-to-creatinine (ACR) test kit, a type of screen used to detect kidney impairment. The EHR-friendly diagnostic tool can now be used at any pharmacy, urgent care center or health clinic.


The FDA approved Abbott’s Proclaim XR, an app-connected neurostimulation system for chronic pain. The product delivers lower energy electrical pulses of spinal cord stimulation, an approach that, according to the company, allows the system a lifetime of 10 years before running out of power.


In October the Dexcom G6 Pro Continuous Glucose Monitoring System got clearance from the FDA. The latest technology can gather real-time glucose data over a period of 10 days and has the ability to be switched to blinded mode or unblinded mode. 

In blinded mode, patients don’t see their data automatically; instead, the clinician will get the data and then be able to discuss it with the patient retrospectively. In unblinded mode, users will be able to see their data as it comes in. 


Following a November FDA clearance, WellDoc announced that its BlueStar system will include integrated glucose level insights related to food, medication and activity that are based on the data from their Dexcom CGM. These data will be available to a user’s clinician as well, so that they may review and adjust an ongoing treatment plan if necessary. In addition, the platform picked up a new insulin on board feature that helps gauge how much insulin is active in the body from previous doses.


UK-based health technology firm Ultromics received clearance from the US Food and Drug Administration (FDA) for its cardiovascular image analysis system, EchoGo Core. EchoGo applies artificial intelligence (AI) to automate the analysis and quantification of ultrasound-based heart scans.


Earlier this month Israeli deep learning startup Zebra Medical Vision earned its fourth FDA 510(k) clearance, this time for an algorithm that helps radiologists spot pleural effusion from chest X-ray images. According to the company, this is the first-ever clearance for pleural effusion — a buildup of fluid in the lungs — that the FDA has granted.


This month, etectRx scored FDA 510(k) clearance for its ID-Cap System, a prescription ingestible system that sends adherence event logs to an external medical device. Similar to the system pioneered by etectRx’s high-profile competitor, Proteus Digital Health, the ID-Cap’s core is a standard capsule containing a sensor that transmits a message once it comes into contact with stomach fluid.

However, the ID-Cap System’s receiving device does not need to be adhered to the user’s skin — as is the case for Proteus’ system — but can instead be worn on a lanyard. This receiver then forwards the adherence event data to secure provider web portal, by way of an intermediary patient smartphone app.


In mid-December the FDA also granted a De Novo clearance for Tandem Diabetes Care’s Control-IQ Technology, an interoperable automated glycemic controller device for use in a hybrid closed-loop diabetes management system. The product acts as a new feature for the company’s interoperable t:Slin M2 insulin pump. The controller algorithm allows the pump and its connected system to automatically adjust insulin delivery when connected to an alternate controller-enabled insulin pump and an integrated continuous glucose monitor.

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