De Novo Clearance

EUAs help push FDA to record novel-device nods in 2020

(Image courtesy of the FDA)

The FDA approved, cleared or authorized a record high of 132 novel medical devices in 2020, with pandemic-related emergency use authorizations (EUAs) adding significantly to the total.

That compares with 29 novel devices the agency authorized in 2010, according to a new article by officials from the agency’s Center for Devices and Radiological Health (CDRH).

Novel devices include those brought to market through the premarket approval (PMA), humanitarian device exemption (HDE) and de novo pathways, as well as a subset of those that gain 510(k) clearance or an EUA.

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Baxter’s dialysis filter wins De Novo nod

Baxter (NYSE:BAX) announced today that it received FDA De Novo classification for its Theranova novel dialysis membrane.

Theranova is designed to deliver expanded hemodialysis (HDx) therapy, filtering a wider range of molecules from the blood than traditional hemodialysis (HD) filters, targeting certain molecules associated with inflammation and cardiovascular disease in patients with kidney failure, according to a news release.

HDx is similar to conventional HD, but has a change of the dialyzer membrane, allowing the Theranova’s “medium cut-off” membrane to combine high permeability and selectivity for uremic toxins while retaining essential proteins and maintaining albumin levels during treatment.

Deerfield, Ill.-based Baxter conducted a randomized, controlled study of Theranova in the U.S., evaluating safety and efficacy. After observing 172 hemodialysis patients who received therapy through either a medium cut-off dialyzer (Theranov…