USA — According to FDA data, fewer digital health breakthrough technologies have been approved for marketing this year than in 2021.
However, the majority of those who did receive FDA approval did so in the latter half of 2021, so the year-on-year gap may still narrow.
From 2015 to the end of last month, a total of 728 breakthrough designations were granted for medical devices, with 56 gaining marketing authorization.
In particular, the FDA granted 206 breakthrough designations in 2021 and has already granted 164 this year.
In terms of clinical panel, breakthrough designations have been most frequently granted in the cardiovascular and neurology spaces since 2015, with 167 and 132 designations, respectively.
To date in 2022, digital health breakthrough technologies that received marketing authorizations include Magnus Medical’s SAINT neuromodulation system for major depressive disorder, Renovia’s leva pelvic health system as a first-line treatment for chronic fecal incontinence, and NeuroMetrix’s wearable neuromodulation device Quell, touted as the first non-pharmacological therapy for fibromyalgia.
Meanwhile, digital health technologies that were greenlighted in 2021 include Koios Medical’s Koios DS, an artificial intelligence (AI)-based software platform used to diagnose thyroid and breast cancer; AppliedVR’s virtual reality system EaseVRX for chronic back pain.
Other devices approved include SyncThink’s Eye-Sync as a diagnostic aid for concussion; Paige.AI’s Paige Prostate for prostate cancer detection; Cognoa’s AI-driven diagnostic aid Canvas Dx for autism; and Helius Medical’s PoNS device, a portable neuromodulation stimulator to help improve walking ability in patients with multiple sclerosis.
On a positive outlook, the number of authorizations for novel devices has more than quadrupled in the last decade, from 29 in 2010 to a high of 132 green lights in 2020.
This has been driven in part by a flood of submissions from companies looking to combat the spread of COVID, with 2020 applications up more than 60% from the previous year.
Moreover, despite including over 1,400 requests for Emergency Use Authorizations (EUAs), this year’s total volume through mid-October has decreased by less than 20% compared to 2019.
Throughout the COVID pandemic, the FDA received over 8,000 emergency authorization requests and approved over 2,300 devices, including 444 diagnostic tests, through the end of September.
Now, as the public health emergency winds down and the coronavirus becomes more endemic and potentially seasonal, similar to the flu, the FDA is preparing to pivot.
As EUAs expire, developers of many COVID tests and products will need to obtain full marketing clearances.
The agency is currently working to finalize two draft guidance documents on transition policies, which are expected to be published within the next few months.
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