Smart pill firm Proteus raises $172 million | Reuters

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Updated November 1, 2025

Proteus went bust.

Read about it here:

Otsuka approved to buy bankrupt smart-pill maker Proteus’ assets, overcoming opposition from Novartis - StatNews:
https://www.statnews.com/2020/08/19/otsuka-approved-proteus-sale-abilify-mycite/

---  the original post follows below  ---

Read the full article: Smart pill firm Proteus raises $172 million | Reuters:

"A U.S. biotech company pioneering tablets containing embedded microchips that can tell if patients have taken their medication has raised a further $172 million, showing investor interest in its ingestible and wearable technology.

Privately held Proteus Digital Health, which is working with drugmakers including Novartis and Otsuka, said on Tuesday the funding was one of the biggest U.S. private financings this year and the largest in the digital health sector.

Proteus already has European and U.S. approval for its "smart pill" technology system, in which a tiny sensor is embedded in a tablet and linked to a patch worn on the patient's abdomen."

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Health app users beware: Column - USA Today

Health app users beware: Column - USA Today:

"But how many are actually useful? An analysis by the IMS Institute for Healthcare Informatics found that only about 40% of those apps — 16,000 — are "truly related to health care" and oriented toward the consumer patient. Of those, two-thirds offered patients legitimate medical information."

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FDA 101 Digital Health Guide - Free Rock Health Report

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Does your mobile health app need FDA clearance? Checklist gives guidance for digital health entrepreneurs | MedCity News:

In a report dubbed “FDA 101,” health startup accelerator Rock Health has compiled a handy report to help digital health entrepreneurs assess whether their mobile health apps would be classified as medical devices by the FDA and require 510(k) clearance. Rock Reports - FDA 101 - A guide for digital health entrepreneurs

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FDA regulators face daunting task as health apps multiply

Jenny Gold reports that, "In fact, there are 40,000 medical applications available for download on smartphones and tablets — and the market is still in its infancy. But that growth is in the cross hairs of new regulatory efforts from the Food and Drug Administration."

FDA regulators face daunting task as health apps multiply – USATODAY.com:

"Franko's goal is to make sure doctors and patients know what they're getting as quickly as possible. "These apps already exist," he says, "and people are using them in hospitals to make medical decisions, but no one knows if they're actually doing what they claim to be doing.""

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This is all about mobile, tablet, digital technologies intersecting the FDA's QSR regulations applicable to medical device manufacturers (i.e., 21 CFR 820).

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Essentials for Medical Device Manufacturers - Recommended QSR Training - SkillsPlus Intl Inc.
21 CFR 820 Essential Elements - The Best Online QSR Training - SkillsPlus Intl Inc.

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FDA Issues Guidance For Mobile Medical Applications

Updated June 30, 2023

This topic has evolved over the years. Therefore, the original links broke.

You can still read about this same topic here:

Device Software Functions Including Mobile Medical Applications - FDA.gov

---  the original post follows below  ---

The U.S. Food and Drug Administration (FDA) announced it is seeking input on its proposed oversight approach for certain mobile applications specific to medicine or health care called mobile medical applications ("apps") that are designed for use on smartphones and other mobile computing devices. This approach encourages the development of new apps, focuses only on a select group of applications and will not regulate the sale or general consumer use of smartphones or tablets.

Today, mobile medical applications or "mobile medical apps," include a variety of functions, ranging from monitoring calorie intake, helping people maintain a healthy weight, and allowing doctors to view a patient’s radiology images on their mobile communications device. According to Research2Guidance 2010, 500 million smartphone users worldwide will be using a health care application by 2015.

"The use of mobile medical apps on smart phones and tablets is revolutionizing health care delivery," said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. "Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don’t work as intended."

The agency’s draft guidance defines a small subset of mobile medical apps that impact or may impact the performance or functionality of currently regulated medical devices. This subset includes mobile medical apps that:

A. are used as an accessory to medical device already regulated by the FDA

(For example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet); or

B. transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices

(For example, an application that turns a smartphone into an ECG machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack).

For more information:

FDA: Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications

FDA: Consumer Update - FDA Proposes Health 'App' Guidelines

FDA:  Mobile Medical Applications

Digital Drugs - This is a must read!

OK, I just can't pass this one up. I've never heard of this before. Apparently, so-called digital drugs are audio files designed to induce drug-like effects. These audio files are also called idozers or idosers. I guess we should be worried if they really work and people are listening to them on their mp3 players while driving, etc. Read the full, very interesting ABC News article, "Web Delivers New Worry for Parents: Digital Drugs - Reports of Sounds With Drug-Like Effects Have Some Parents Spooked. " After reading this, it all seems plausible, binaural beats mimicking brain wave frequencies. You've got to read this, and decide for yourself. Hmmm, imagine the kid on the bus, looking like he's tripping on acid (LSD).

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