What the FDA’s 2026 Wellness Device Update Means for Wearables

With more and more sensors being crammed into the consumer devices that many of us wear every day, the question of where medical devices begin and end, and how they should be regulated become ever more pertinent. When a ‘watch’ no longer just shows the time, but can keep track of a dozen vital measurements, and the line between ‘earbud’ and ‘hearing aid’ is a rather fuzzy one, this necessitates that institutions like the US FDA update their medical device rules, as was done recently in its 2026 update.

This determines how exactly these devices are regulated, and in how far their data can be used for medical purposes. An important clarification made in the 2026 update is the distinction between ‘medical information’ and ‘signals/patterns’. Meaning that while a non-calibrated fitness tracker or smart watch does not provide medically valid information, it can be used to detect patterns and events that warrant a closer look, such as indications of arrhythmia or low blood oxygen saturation.

As detailed in the IEEE Spectrum article, these consumer devices are thus ‘general wellness’ devices, and should be marketed as such, without embellished claims. Least of all should they be sold as devices that can provide medical information.

Another major aspect with these general wellness devices is what happens to the data that they generate. While not medical information, it does provide health information about a person that e.g. a marketing company would kill for to obtain. This privacy issue is unresolved in the US market, while other countries prescribe strict requirements about such data handling.

Effectively, this leaves the designers of wearables relatively free to do whatever they want, as long as they do not claim that the medical data being produced from any sensors is medical information. How this data is being handled is strictly regulated in most markets, except for the US, which is quite worrying and something you should definitely be aware of.

As for other medical device purposes like hearing aids, the earbuds capable of this fortunately do not generally collect information. They do need to have local regulatory approval to enable the feature, however, even if you can bypass any geofencing with some creative hacking.

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A Basic Guide To Shielding

[GreatScott] has recently been tinkering in the world of radio frequency emissions, going so far as to put their own designs in a proper test chamber to determine whether they meet contemporary standards for noise output. This led them to explore the concept of shielding, and how a bit of well-placed metal can make all the difference in this regard.

The video focuses on three common types of shielding—absorber sheets, shielding tapes, and shielding cabinets. A wide variety of electronic devices use one or more of these types of shielding. [GreatScott] shows off their basic effectiveness by putting various types of shielding in between a noise source and a near-field probe hooked up to a receiver. Just placing a bit of conductive material in between the two can cut down on noise significantly. Then, a software defined radio (SDR) was busted out for some more serious analysis. [GreatScott] shows how Faraday cages (or simple shielding cabinets] can be used to crush down spurious RF outputs to almost nothing, and how his noisy buck-boost designs can be quieted down with the use of the right absorber sheets that deal well with the problematic frequencies in question. The ultimate upshot of the tests is that higher frequencies respond best to conductive shielding that is well enclosed, while lower frequency noise benefits from more absorptive shielding materials with the right permeability for the job.

Shielding design can be a complex topic that you probably won’t master in a ten minute YouTube video, but this content is a great primer if you’re new to the topic. We’ve covered the topic before, too, particularly on how a bit of DIY shielding can really aid a cheap SDR’s performance. Video after the break.

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A Computer That Fits Inside A Camera Lens

For a long while, digital single-lens reflex (DSLR) cameras were the king of the castle for professional and amateur photography. They brought large sensors, interchangeable lenses, and professional-level viewfinders to the digital world at approachable prices, and then cemented their lead when they started being used to create video as well. They’re experiencing a bit of a decline now, though, as mirrorless cameras start to dominate, and with that comes some unique opportunities. To attach a lens meant for a DSLR to a mirrorless camera, an adapter housing must be used, and [Ancient] found a way to squeeze a computer and a programmable aperture into this tiny space.

The programmable aperture is based on an LCD screen from an old cell phone. LCD screens are generally transparent until their pixels are switched, and in most uses as displays a backer is put in place so someone can make out what is on the screen. [Ancient] is removing this backer, though, allowing the LCD to be completely transparent when switched off. The screen is placed inside this lens adapter housing in the middle of a PCB where a small computer is also placed. The computer controls the LCD via a set of buttons on the outside of the housing, allowing the photographer to use this screen as a programmable aperture.

The LCD-as-aperture has a number of interesting uses that would be impossible with a standard iris aperture. Not only can it function as a standard iris aperture, but it can do things like cycle through different areas of the image in sequence, open up arbitrary parts or close off others, and a number of other unique options. It’s worth checking out the video below, as [Ancient] demonstrates many of these effects towards the end. We’ve seen some of these effects before, although those were in lenses that were mechanically controlled instead.

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Thanks to [kemfic] for the tip!

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Retrotechtacular: Mr. Wizard Jams with IBM

You may not remember [Mr. Wizard], but he was a staple of nerd kids over a few decades, teaching science to kids via the magic of television. The Computer History Archives Project has a partially restored film of [Mr. Wizard] showing off sounds and noise on a state-of-the-art (for 1963) Tektronix 504 oscilloscope. He talks about noise and also shows the famous IBM mainframe rendition of the song “Daisy Bell.” You can see the video along with some extras below.

You might recall that the movie “2001: A Space Odyssey” paid homage to the IBM computer’s singing debut by having HAL 9000 sing the same song as it is being deactivated. The idea that HAL was IBM “minus one” has been repeatedly denied, but we still remain convinced.

Can you imagine a TV show these days that would teach kids about signal-to-noise ratio or even show them an actual oscilloscope? We suppose that’s what YouTube is for.

At about the 17-minute mark, you can see some enormous walkie-talkies. A far cry from today’s cell phones. At the 27-minute mark, another film shows how engineers at Bell created the song using a mainframe.

We wish there were a modern version of [Mr. Wizard]. Then again, there’s no reason you can’t fill in. You might not be on TV, but you can always drop in on a few classrooms.

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Keebin’ with Kristina: the One With the NEO With the Typewriter Shell

Isn’t this glorious? If you don’t recognize what this is right away (or from the post title), it’s an AlphaSmart NEO word processor, repackaged in a 3D-printed typewriter-esque shell, meticulously designed by the renowned [Un Kyu Lee] of Micro Journal fame.

Image by [Un Kyu Lee] via GitHubIf you don’t want to spend roughly 40 hours printing ~1 kg of filament in order to make your own, you can join the wait-list on Tindie like I did. Go here to figure out which color you want, and email [Un Kyu Lee] when you order. In the meantime, you can watch the assembly video and then check out this playlist that shows the available colors.

Assembly looks easy enough; there’s no soldering, but you do have to disconnect and reconnect the fiddly ribbon cables. After that, it’s just screws.

This design happened by accident. A friend named [Hook] who happens to manage the AlphaSmart Flickr community had given [Un Kyu Lee] a NEO2 to try out, but before he could, it fell from a shelf and the enclosure suffered a nasty hole near the screen. But the internals seemed fine, so he got the idea to design a new enclosure.

I don’t believe the knobs do anything, but they sure do look nice. There’s an area along the top where you can clip a light, since the NEO has no backlight. There are also two smaller slots on the sides if your light won’t clip to the top.

I’d really like to do this to one of my NEOs. I have two NEO regulars, but reviewers on Tindie report that it works just as well with those as the NEO2.

IBM 701c Butterfly Keyboard Flaps Its Wings Again

I feel like this wonderful laptop and its butterfly keyboard come up often enough, but for today’s lucky 10,000, the IBM 701C laptop has a sweet keyboard that automatically extends when the lid is opened, kind of like one of those special birthday cards.

Image by [LCLDIY] via Hackaday.IO[LCLDIY] found such a laptop at a junkyard with no screen, a damaged motherboard, and a shell that’s old and broken. He decided to try to save it with 3D printing, and well, it worked.

First, he obtained a replacement screen and motherboard, and set about modeling a new case. Be sure to watch the video below so you can catch the machine [LCLDIY] does his modeling on. Now, here’s a surprise: the filament is all hand-spun from plastic bottles he collected from the streets.

Once the case was done, he ran into a slight problem. Namely, the keyboard has a ribbon cable and not a USB interface, so he had to make a PCB to handle that and get it over to the motherboard. Really, [LCLDIY] did so much more than save a keyboard; he built an entire laptop around it. To that, I say kudos. Kudos from Kristina.

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The Centerfold: the Smurve80 Is a Thing You Could Buy

Image via reddit
What is this? A baby Model M? A Unicomp? Neither — it is the Smurve80 from Play Keyboard x Swagkeys. This 87-key TKL is heavily inspired by the Model M, however, down to the curved keyboard. And the name? It’s an amalgamation of ‘smile’ and ‘curve’, and this is reflected in the unfortunately Amazon-like logo in the upper left. I might get one anyway. I haven’t decided. If I do, you can bet I will probably be reviewing it.

Here’s the full info post, and here’s the post about the group buy, which is live now (NA link) through February 16th at 10PM ET. Not in North America? Check the group buy post for a list of vendors. For a mere $100, this baby can be yours in either Sandstone (pictured) or Graphite (semi-pictured), and that’s the fully assembled price. There’s also a bare-bones kit version. The best part, aside from the price, has to be the built-in solenoid. So you can get it with reds if you want, but it’s gonna be loud regardless. Just kidding; you can switch off the solenoid.

Do you rock a sweet set of peripherals on a screamin’ desk pad? Send me a picture along with your handle and all the gory details, and you could be featured here!

Historical Clackers: the Wellington

Are you familiar with Wellington Parker Kidder? His name is nearly as one with typewriter history as Christopher Latham Sholes (the guy responsible for QWERTY). I myself had not heard of Kidder, but his name is directly and indirectly associated with dozens of machines, including the Franklin, the Rochester, and the Noiseless, which was later bought by Remington. Then there’s all the clones of his work.
Image via The Antikey Chop
Kidder’s patents for the Wellington first appeared in 1892. The appeal of this machine is in the thrust-action type bars, which punch the platen rather than swinging to strike it. The design was well-received, and the Wellington was produced virtually unchanged from 1892 to 1924.

There were two models, No. 1 and No. 2. The former had square key tops, while the latter featured rounded key tops. Both models had a three-row keyboard with a double-shift mechanism, and used an extra-wide ribbon. They also both had that attractive cover on the type bars that reminds me of the fender skirts on, say, a 1950 Mercury.

And much like that 1950 Mercury, Wellingtons were well-built, but unfortunately the passage of time has proven them to be rust buckets. That’s really sad to me and I wish I could forget the fact.

The Wellington sold well enough in the States, but it really shone in Europe. Many typewriters are based on the either the overall design, or at least the type bar mechanism. Antikey Chop calls Kidder’s Wellington one of the most influential typewriters of all time, and I believe it.

Finally, the Zerowriter Is Shipping For Early Backers

In case you don’t have an AlphaSmart NEO and/or dislike the Freewrite for whatever reason, there’s also the Zerowriter, created by a one-man team out of Canada. You can pre-order it today for $279 and it’ll ship March 30th for free, worldwide.
Image via Good E-Reader
So, what is this thing? It’s a distraction-free writing tool with an e-ink screen and a low-profile mechanical keyboard. The battery is supposed to last a long time, and it’s cheaper than a Freewrite.

This thing has Kailh Choc Pro red switches, which are thankfully hot-swappable. Much like the NEO, it comes on and is instantly ready for typing. There’s no account to register, no login to memorize. Files are saved as .txt to a microSD card and can be transferred to a computer, though unlike the NEO, there’s a companion app standing between you and file transfer.

That said, this baby uses an ESP32 and was coded in Arduino, so do what you will. The battery is supposed to last for weeks of daily use on a single charge. It’s a user-replaceable LiPo pouch with USB-C charging. They actually encourage you to open her up, and I think that’s great.

Got a hot tip that has like, anything to do with keyboards? Help me out by sending in a link or two. Don’t want all the Hackaday scribes to see it? Feel free to email me directly.

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