New market guidances, regulatory pathway change proposals close out 2018 for FDA

The regulatory changes also come alongside Pre-Cert Program updates and roughly a dozen noteworthy digital health approvals.
By Dave Muoio
02:39 pm

The last few months of 2018 have been fairly active for digital health regulation, with the US FDA roughly a dozen noteworthy devices and consumer health products. But the bigger news out of the agency this quarter comes in the form of its market guidance.

For instance, the very beginning of October saw the release of the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook — a document co-authored by the FDA and the non-profit Mitre Corporation that describes how healthcare delivery organizations can best prepare their medical devices and staff for a device security breach. The release was paired with two memoranda of understanding with “multiple stakeholder groups” focuses on medical device security.

Just a few weeks later the agency would go on to release an update to its premarket guidance for medical device cybersecurity. Compared to a similar document released in 2014, this new guidance stresses to device makers the need for digital health products that can support software-level security improvements and forensic evidence capture, among other important security features.

“It really builds upon the principles [of the 2014 guidance], but it provides a lot more granularity. It’s a much deeper dive, and it’s really informed by what we’ve seen over the past few years … [with] attacks such as WannaCry or on Hollywood Presbyterian,” Dr. Suzanne Schwartz, associate director for science and strategic partnerships at the FDA, said in October at the Healthcare Security Forum in Boston. “The notion that the clinical operations within an organization can be disrupted, and how that cascading effect results in the potential for patient injury or patient safety being at risk, those are concerns that we felt was going to be critical to address in the premarket updated guidance.”

Most recently, the FDA has also been exploring changes to its premarket review pathway. In mid-November, the agency released a proposed framework that would classify the majority of apps and software released by pharmas that accompany a drug treatment as “promotional labeling,” and therefore require less stringent review. Before that month’s end, it would also announce plans to require more modern predicate devices as well as objective safety and performance criteria in regulatory submissions (with word of similar changes to other aspects of the regulatory and post-market processes still to come).

Of course, there were a handful of headlines regarding the agency’s other well-publicized initiatives as well. Just this month it selected and announced the eight winners of an opioid addiction innovation challenge that saw applications from more than 250 hopefuls. Meanwhile the experimental Pre-Cert Program saw its fair share of ups and downs in the form of early praise from its participants and a very critical letter penned by Democratic senators.

And each of these updates came concurrent with the agency’s regular work approving new health products. Here is a list of the biggest such clearances in digital health:

Bethesda, Maryland-based startup RightEye scored FDA 510(k) clearance for its cloud-based eye-tracking system and software. The technology was designed to help clinicians identify visual tracking impairments in patients by recording, viewing and analyzing a patient’s eye. The system has four main target areas: functional vision screening, reading assessments, sports vision assessment and training and brain health. 

FibriCheck received FDA 510(k) clearance for its app, which uses a smartphone’s camera and artificial intelligence to monitor for heart rhythm disorders. To identify atrial fibrillation, FibriCheck monitors the user's heart rhythm via photoplethysmography. From there, an algorithm within the app analyzes its measurements to determine whether the user’s condition is cause for concern. Of note, the tool does not require any additional hardware to measure its users.

Novarad’s OpenSight Augmented Reality System received FDA clearance for pre-operative surgical planning using the tech company's augmented reality headset. The system uses the lens to project 2D, 3D and 4D interactive images onto a patient’s body during surgery. The system lets clinicians see both the 3D patient image from previous scans as well as the patient physically in front of them.

FDA permitted marketing of 23andMe’s Personal Genome Service Pharmacogenetic Reports test, with some caveats. The test offers consumers information on whether they posses one of 33 variants across multiple genes that could impact their body’s ability to metabolize certain medications. The agency stressed that these are not to be the sole genetic testing results considered by the patient or the provider when weighing treatment options, and that any decisions should instead be based on independent pharmacokinetic clinical testing. To reflect this stipulation, FDA granted the De Novo authorization with eight “special controls,” including a labeling requirement warning the consumer not to use the test results for any medication decisions.

Just a short while after securing a CE Mark for its second generation device, Abbott was granted FDA clearance for FreeStyle LibreLink, a companion mobile app for its 10 to 14-day CGM. The launch adds a long-awaited feature for US users that’s been available for some time in Europe: users will be able to scan their sensors with an app on their smartphone — and see their latest reading — rather than requiring a separate, proprietary handheld reader (although the reader will still be an option for those that prefer it).

Clinical diagnostic and workflow software maker MaxQ AI received FDA 510(k) marketing clearance for Accipio Ix, an artificial intelligence workflow tool designed to help clinicians prioritize adults patients likely presenting with acute intracranial hemorrhage. Results generated by the algorithm-based software are not intended to be used on their own as a standalone diagnostic or for clinical decisions. Rather, the tool automatically retrieves and processes non-contrast CT images to provide a case-level indicator, which is used to triage cases most in need of expert review.

FDA granted De Novo clearance to Atlantic Therapeutics’ Innovo therapy device, an externally worn electrical muscle stimulator for the treatment of stress urinary incontinence. The wearable is intended for adult women as a front-line or second-line therapy, and in a multi-center randomized controlled trial recorded an 87 percent rate of mild or no incontinence after 12 weeks of use.

Basking Ridge, New Jersey-based medical device maker Electrocore received a 510(k) clearance expanding the label of its non-invasive vagus nerve stimulator (VNS) therapy device to include cluster headache prevention. Therapy using the gammaCore device is self-administered, and for cluster headache prevention consists of two daily treatments, each of which is comprised of three consecutive two-minute stimulations. To do so, patients apply a conductive gel to the side of their neck, and then hold the gammaCore to the same area while it dispenses a mild electrical stimulation through the skin and to the vagus nerve.

The FDA granted a 510(k) clearance to POPS! Diabetes Care for its POPS! one blood glucose monitoring system. The system is made up of a diabetes coaching app and a small glucose meter that attaches to the back of a user’s smartphone. Users can check their glucose levels on the meter and the results will automatically transfer to the app. Users can track their glucose trends via the app and have the option to send their results to loved ones or a provider. 

The FDA officially cleared reSET-O — a digital therapeutic to treat opioid use disorder (OUD) jointly developed by Pear Therapeutics and Sandoz, a division of Novartis — a little over a year after it was granted an Expedited Access Pathway designation from the agency. Patients will need a valid prescription from their licensed provider in order to access the therapeutic. The therapeutic employs cognitive behavioral therapy (CBT) to help outpatients living with OUD. reSET-O is intended to be used by patients who are currently under the supervision of a clinician along with other outpatient treatments including medication-assisted-treatment, such as transmuscosal bupernorphine. 

The FDA approved Medtronic’s app-based smart programming device used to discreetly and easily control implants treating for overactive bladder (OAB), chronic fecal incontinence (FI) and non-obstructive urinary retention, medical device maker Medtronic announced yesterday. Called the InterStim smart programmer and designed for use with Medtronic’s InterStim system, the product consists of a Samsung touch screen device running an app-based platform. With it, patients can adjust the therapy being delivered by multiple implants, while their physicians can access the platform to see a detailed breakdown of their therapy and adjust limits as need be.

Omron Healthcare’s HeartGuide wristwatch — a wearable oscillometric wrist blood pressure monitor unveiled earlier this year at CES 2018 — has received FDA clearance and will be available at retail on January 9, 2019. The key feature of the product is a flexible synthetic band that is designed to inflate and maintain its shape when taking a blood pressure reading, yet remain comfortable on the wrist. According to the company, more than 80 patents were filed directly relating to band and other components required when designing the new device.


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