• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

Bigfoot Biomedical wins FDA clearance for Bigfoot Unity Android app

March 2, 2023 By Sean Whooley

Bigfoot Biomedical Bigfoot Unity
The Bigfoot Unity platform. [Image courtesy of Bigfoot Biomedical]
Bigfoot Biomedical announced today that it received FDA 510(k) clearance for the Android version of its Bigfoot Unity mobile app.

Milpitas, California-based Bigfoot received FDA clearance for its diabetes management platform in May 2021. Its initial rollout featured compatibility with iOS devices. The first-of-its-kind system includes connected smart pen caps designed to recommend insulin doses for diabetes patients using multiple daily injection (MDI) therapy.

Bigfoot’s smart pen caps offer on-demand insulin dose decision support. This helps to minimize guesswork and help patients to follow their doctors’ instructions. Additionally, the caps have compatibility with a broad range of disposable insulin pens for both long-acting and rapid-acting insulin.

The mobile app allows users to input and review therapy recommendations from healthcare professionals. Users can also access a glanceable display of their current glucose range and receive real-time alerts.

The company describes the Android version as a “necessary component” of its diabetes management system. According to a news release, 41% of U.S. smartphone users choose Android devices. Once commercially launched, Bigfoot expects the app to be made available via the Google Play Store.

“Most Bigfoot Unity users live with type 2 diabetes and are part of a demographic that is even more likely to use Android devices than the general U.S. population,” said Jeffrey Brewer, CEO. “Therefore, as we prepare for our enhanced commercial rollout later this year, this clearance is key to enabling us to expand access to our comprehensive and easy-to-use solution and deliver on our goal to minimize the anxious guesswork involved with insulin dosing.”

Today’s announcement marks more big news for the company that sold automated insulin delivery patents to Insulet for $25 million last month.

Read next: How Bigfoot Biomedical plans to take diabetes management forward

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Patient Monitoring, Regulatory/Compliance, Technology Tagged With: Bigfoot Biomedical, FDA

IN CASE YOU MISSED IT

  • Insulet hires new chief HR officer from J&J
  • Breakthrough T1D, Mattel debut Barbie doll with type 1 diabetes
  • Medtronic Diabetes names CFO with consumer experience ahead of separation
  • Diabeloop launches insulin delivery algorithm in Germany
  • GlucoModicum has positive data for needle-free CGM

About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy | RSS