BOSTON, Dec. 10, 2019 (GLOBE NEWSWIRE) — Beta Bionics, Inc. — a medical technology company developing and aiming to commercialize the world’s first fully automated bionic pancreas — today announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its investigational iLet Bionic Pancreas System.
- The iLet is a pocket-sized, wearable investigational medical device that autonomnously controls blood sugar in people with diabetes and other conditions — it is the world’s first bionic pancreas system
- FDA’s Breakthrough Device Designation Program provides Beta Bionics with priority review among other benefits related to FDA interaction
- The iLet Bionic Pancreas System was granted breakthrough designation in all configurations (insulin-only, glucagon-only, and bihormonal), including use with Zealand Pharma’s dasiglucagon, a glucagon analog with a unique stability profile in a ready-to-use aqueous solution
From DiabetesMine: IMPORTANTLY, this is NOT an FDA clearance for the product in order for patients to get it. This is part of the regulatory pathway, meant to potentially speed up the end-result of commercialization. Other closed loop system developers have obtained this designation in past years: Bigfoot Biomedical was the first in 2017, while Medtronic followed in Feb. 2019 for its Personalized Closed Loop system and Korea-based EoFlow got it in March 2019 for its future EOPancreas system in the works. Here’s to moving forward on faster regulatory pathways!
Read more: Beta Bionics Receives FDA Breakthrough Device Designation for the iLet™ Bionic Pancreas System
Long awaited, much anticipated, now its time to put the rubber on the road.
The iLet sounds great but as we know, the FDA has a long history of dragging things out and not approving beneficial treatments for reasons known only to the agency (e.g. SGLT-2 use in T1 diabetes).