Skip to main content

The FDA has approved the first digital pill

The FDA has approved the first digital pill

/

Abilify MyCite raises new privacy concerns

Share this story

Example of a digital medicine system
Example of a digital medicine system
Photo: Proteus Digital Health

The Food and Drug Administration has approved the first digital pill for the US which tracks if patients have taken their medication. The pill called Abilify MyCite, is fitted with a tiny ingestible sensor that communicates with a patch worn by the patient — the patch then transmits medication data to a smartphone app which the patient can voluntarily upload to a database for their doctor and other authorized persons to see. Abilify is a drug that treats schizophrenia, bipolar disorder, and is an add-on treatment for depression.

The Abilify MyCite features a sensor the size of a grain of sand made of silicon, copper, and magnesium. An electrical signal is activated when the sensor comes into contact with stomach acid — the sensor then passes through the body naturally. A patch the patient wears on their left rib cage receives the signal several minutes after the pill is ingested. The patch then sends data like the time the pill was taken and the dosage to a smartphone app over Bluetooth, and must be replaced every seven days. The patient’s doctor and up to four other people chosen by the patient, including family members, can access the information. The patient can revoke access at any time.

Example of a digital medicine system
Example of a digital medicine system
Photo: Proteus Digital Health

The pill comes after years of research and is a venture between Japanese pharmaceutical company Otsuka and digital medicine service Proteus Digital Health, which makes the sensor. The pill is one way to address the prevalent problem of patients not taking their medication correctly, with the IMS Institute estimating that the improper and unnecessary use of medicine cost the US healthcare sector over $200 billion in 2012. The approval also opens the door for pills that are used for other conditions beyond mental health to be digitized.

Example of a digital medicine system
Example of a digital medicine system
Photo: Proteus Digital Health

Experts though, have expressed concerns over what the pill might mean for privacy. Some are worried that tracking pills will be a step towards punishing patients who don’t comply. Ameet Sarpatwari, an instructor in medicine at Harvard Medical School told The New York Times the digital pill “has the potential to improve public health. [But] if used improperly, it could foster more mistrust instead of trust.”

The Wall Street Journal reports that the FDA is anticipating a potential raft of approval requests for other digital pills. A spokesperson told the publication the FDA is planning to hire more staff with "deep understanding" of software development in relation to medical devices, and engage with entrepreneurs on new guidelines.

Otsuka hasn’t indicated how much the digitized Abilify pills will cost yet. The WSJ reports the company plans to work with some insurers in covering the digitized pills with production planned to be ramped up only if it can find willing insurers.

Correction November 16th, 11:07am ET: A previous version of this story listed additional features in the MyCite patch that were listed on the manufacturer's website. The story has been changed to reflect the FDA-approved features.

Today’s Storystream

Feed refreshed 28 minutes ago Yes, it happened again.

J
Twitter
Jay Peters28 minutes ago
Control’s lead designer shared video of an early build of the game with in-development graphics.

Some have criticized GTA VI’s graphics seen in the videos that leaked this weekend. But this early footage of Control shows how even some of the best-looking games use placeholder assets during development that are improved upon for a game’s final release. I’m a big fan of the boxes with “THROW ME” printed on the sides.


M
External Link
Mitchell Clark42 minutes ago
Satellite-to-phone service is getting closer.

The FCC has given Lynk, one of the companies competing with SpaceX, T-Mobile, and Apple, a license to operate a commercial satellite-to-mobile communication service (though currently it’s only for coverage outside the US).

Lynk will still have to find a mobile carrier to work with and get FCC approval for that specific service, but it’s now cleared an important hurdle — plus, the company’s CEO told Fierce Wireless that it’s currently “working with testing” for two US carriers.


E
External Link
Emma Roth56 minutes ago
Mob Psycho 100’s lead voice actor is likely getting replaced — and it’s all because of company politics.

Kyle McCarley, the voice of Shigeo “Mob” Kageyama in the dubbed version of Mob Psycho 100, probably won’t be returning for the anime’s third season. McCarley posted a video on YouTube, claiming the Sony-owned anime streamer Crunchyroll refused to work with him on a Screen Actors Guild - American Federation of Television and Radio Artists (SAG-AFTRA) union contract.

According to Kotaku, Crunchyroll confirmed that it will “need to recast some roles,” but doesn’t explicitly mention McCarley or who will play Mob. Needless to say, McCarley’s potential departure is disappointing, especially since his voice fits the role of Mob so well.


J
The Verge
Jacob Kastrenakes7:59 PM UTC
YouTube’s biggest defense against TikTok: money.

The company is going to start giving creators a share of ad revenue when commercials play between YouTube Shorts. The platform’s relatively generous payments are a large part of its rich creator culture, and now we’ll find out if they’re enough to lure short-form creators away from TikTok.


E
Twitter
Elizabeth Lopatto6:55 PM UTC
Signal, the encrypted messaging app, gets free promotion from Twitter’s lawyers.

Last year, Elon Musk tweeted “Use Signal,” leading to a spike in new users. Twitter’s lawyers said in a footnote in a previous filing that Musk had been messaging with investor Marc Andreessen of a16z on Signal about a Twitter investment. The problem for Twitter’s discovery process is that Signal messages can be set to auto-delete; Musk’s lawyers maintain he doesn’t ordinarily use Signal for business. Now, there’s a sealed motion that.... contains Musk’s Signal tweet. 👀


A
Alex Cranz6:32 PM UTC
If you’re into the minimalist PC build then Nvidia’s latest GPUs might present a problem.

Nvidia finally announced the 40-series—specifically the more expensive and more powerful 4090 and 4080. But big power means these are some big cards and that could be a problem for PC builders who prefer smaller, minimalist looks for their PCs. Builders at the /sffpc subreddit, that focuses on small form factor pc builds, are already worried.


B
The Verge
Barbara Krasnoff6:20 PM UTC
A lot of people seem to agree that lock screen widgets are one of the best new features of iOS 16.

So we put together a how-to on customizing your iPhone’s lock screen and wallpaper with widgets and design options, and even linking them to Focus modes. It’s easier than you’d think.


M
Youtube
Mitchell Clark6:09 PM UTC
Apple replaced the iPhone 14 Pro’s SIM slot with a block of plastic.

iFixit’s teardown of the iPhone 14 Pro gives us a look at what’s behind the Dynamic Island, and does a good job of demonstrating why the regular iPhone 14’s removable back glass is so nice.

We also get to see what’s taken the place of the SIM slot: a bare PCB, and a plastic spacer. So useful!


D
External Link
David Pierce4:51 PM UTC
Bluetooth speakerphones are an underrated accessory.

Wirecutter has a good roundup of options, which are as good for Zoom calls as advertised, but they’re also just useful in life! I use mine roughly as a desk phone, and also connect it every time we’re doing the “everyone gather around the phone to talk to Grandma” thing. I have the Jabra Speak 510, and love it.


E
External Link
Elizabeth Lopatto4:28 PM UTC
The SPAC-lash is here.

So remember the craze for SPACs, an alternative way to take a company public? The times, they have a-changed: the SPAC King of Silicon Valley, Chamath Palihapitiya, couldn’t find acquisition targets for two of his piles of cash. One of them, Social Capital Hedosophia VI, is the largest-ever SPAC.


R
Twitter
Richard Lawler4:23 PM UTC
Use every (mega) pixel.

Halide is touted as one of the best photography apps on the iPhone, and as usual, it has a new update out to help you get the most out of the best camera available on the platform — that 48-megapixel sensor on the iPhone 14 Pro.

Version 2.9.0 of Halide is live in the App Store, with quick 48MP shooting directly to HEIC or JPG and many other new features.


N
Quote
Nilay Patel4:21 PM UTC
Speaking of CarPlay.

Dan posted about CarPlay earlier and it reminded me that wireless CarPlay has actually set Apple back in its quest to somehow take over the car market — problems with it disconnecting are the number one complaint from new car owners, according to JD Power. Something to think about as Apple continues its relentless quest to remove all the ports from our phones.

The most frequent problem reported across the industry regardless of powertrain type or brand cachet related to smartphone connectivity. Dropped connections with Apple CarPlay was the number one problem, as Android Auto complaints leveled off from last year. Further, the number of reported problems with wireless Apple CarPlay increased as well, due to the feature being offered in more cars.