Know Labs Inc (KNW)

[tim00mike]

FYI - Senseonics' 180-day Eversense glucose monitor delayed at FDA by COVID-19 pandemic

https://www.fiercebiotech.com/medtech/senseonics-180-day-eversense-glucose-monitor-delayed-at-fda-by-covid-19-pandemic

Senseonics’ plans to roll out its new, long-term diabetes sensor implant will be pushed to the middle of next year as FDA reviewers continue to be swamped by product submissions aimed at the COVID-19 pandemic.

The upcoming version of the Senseonics Eversense continuous glucose monitoring system—a smartphone-connected device, first approved in June 2018, that's inserted completely under the skin—aims to double its life span from 90 days to six months.

But the company has received word from the FDA to expect delays of at least two months for its application while the agency tasks its staff with emergency reviews of coronavirus tests and other medical devices, it said.

The setback matches what Senseonics has heard from other medtech developers currently trying to get their products reviewed, the company said, noting that there's still potential for the FDA to reach an approval decision before the end of 2021’s second quarter.

Earlier this year, the head of the FDA’s device center, Jeff Shuren, described a tsunami of product applications from companies hoping to join the fight against the COVID-19 pandemic—including over 1,200 submissions for diagnostic tests, ventilators, digital tech and more by early October—which has begun to slow the agency’s work in other diseases.

Describing it as a “canary in the coal mine,” Shuren said review times had begun to increase amid growing backlogs due to the high volume. In addition, the FDA may not be able to make commitments to meeting company timelines going forward, officials said at the time