#289: Will the real medical devices please stand up
The one-minute (ish) healthtech roundup, by SomX. Putting millennial rap references in the titles for as long as we're still in business.
Hello healthtech fans.
If you’re in the UK, hope you had a fabulous long weekend. If you’re elsewhere in the world, this is coming to you on Monday because we all give ourselves Friday and Monday off and decide to spend most of it on the UK’s horrendous motorway network, promising ourselves “we’ll leave earlier next year.”
Anyway, a fun week in healthtech… WHOOP does a Series G (G!?), a diagnostic tampon wins a UK healthtech pitchfest, and Apple’s app store now requires declaration of medical device status 👌🏼
🎙 Fancy this newsletter in podcast form? 👇 Well… this week there isn’t one (see above motorway issues for a clue as to why) but you can absolutely click this linky link to get to the pod on Spotify and listen to the wonderful backlog of the SomX team talking about healthtech (and other) things. And if you’re a video>audio kinda person, here’s the SomX YouTube channel if you wanna see us. Go on. Treat yourself.
News Bites 🥪
🍎 Apple’s App Store will show if an app is classified as a regulated medical device: Fantastic news for patient safety and you’d hope this kicks off a real butterfly effect. If your app sits in Health & Fitness or Medical categories in the US, UK or EU, you now need to declare whether it’s a regulated medical device and that status will show up on your App Store product page. New apps must comply immediately and existing apps have (quite a while, annoyingly) until early 2027, after which Apple’s gonna flat out block you. If you are a regulated device, you’ll need to provide your FDA Owner/Operator Number or EU Manufacturer SRN, instructions for use, intended purpose statement and safety info - all public. Good for consumers who currently can’t tell a CE-marked diagnostic from a wellness app that tracks your mood with emojis. It’s maybe worth asking - does a platform label create a false sense of clinical validation? Apple says it confirms regulatory compliance, not efficacy, so you can see where criticism and gaming might come in, but we’re happy with the direction here.
💰 WHOOP raises $575M Series G at $10.1bn valuation: How high up the alphabet does it even go these days? They’re also throwing around names like Cristiano Ronaldo, LeBron James and Rory McIlroy who are now invested, but I’d pay more attention to Abbott and the Mayo Clinic appearing on the cap table. As the gap between the consumer and the healthcare system gets very blurry (and busy with hardware and software) the trend is wearables being taken more seriously as clinical infrastructure with the WHOOPs of the world aiming to become genuine health data platforms. Worth noting that WHOOP got an FDA warning letter last year over its Blood Pressure Insights feature and the FDA reversed course in January. Naughty over-claiming decacorn, you 🫵🏼
🩸 FemTech startup Daye announced as Rewired Pitchfest 2026 winner: Daye is the fantastic women’s health biotech behind the diagnostic tampon that doubles as an at-home tool for detecting high-risk HPV, the leading cause of cervical cancer. For winning, they get advisory support and the potential for an NHS pilot with CW+ - exactly the kind of route-to-adoption that most healthtech startups would chew their own arm off for. Fun fact… Pitchfest alumni include Limbic and Peppy, so the track record of winners going on to actually do things is strong.
🧬 Lucida Medical raises £8.7m for AI-powered prostate cancer diagnostic: The context here matters - there’s a 30% shortfall in clinical radiologists across the UK right now, expected to hit 40% by 2028, and only 55% of men in England were diagnosed before their cancer had spread in 2024. Lucida’s already deployed across 15 NHS hospitals, CE-marked and approved in the EU, and is now going after FDA clearance. There are an estimated 610,000 men living with prostate cancer in the UK (which is up 20% in five years) so this is exactly the type of AI-in-healthcare story that doesn’t need the hype. The bottleneck is real, the workforce gap is documented, and the clinical validation is happening inside the NHS. More of this.
🧪 Same-day UTI test tells doctors which antibiotic actually works [study]: This is novel. University of Reading researchers have built a method that skips culturing entirely… urine goes straight into a cartridge preloaded with antibiotics, optical imaging watches what grows and what doesn't, and you've got an answer in under six hours. In 352 patient samples, it matched standard lab methods in over 96% of cases, which matters because 1/4 NHS urine samples contain resistant bacteria and UTIs have caused over 800,000 hospital admissions in England in five years. Getting the right antibiotic first time isn't a convenience thing, it's a resistance thing. Spin-out Astratus Limited is taking it to market 👀…
🔒 Health data giant CareCloud says hackers accessed patients’ medical records: This is not ideal. The healthcare IT firm serving over 45,000 US providers confirmed that hackers accessed one of its six EHR environments for around 8 hours in mid-March. It’s not yet known what data was taken, or even if anything was exfiltrated, but the company filed the disclosure with the US Securities and Exchange Commission, which suggests this is pretty serious. Did you know EHR data is some of the most valuable on the dark web? Yep. Fantastic criminal package of Social Security numbers, insurance data, diagnoses, and prescription histories. The investigation is ongoing… Take cyber security really ****ing seriously folks.
And finally...
🤖 Humanoid robot tested on a hospital ward. Totally normal: Remember the Milton Keynes penguin robots? Well, they've been upgraded. Sort of. The Unitree G1, a Chinese humanoid robot, is being tested in a hospital setting. If you click the headline, you’ll see a video of it opening drawers, restocking supplies and moving beds. As Bertalan Meskó points out, the Moravec paradox still applies (robots find hard things easy and easy things hard), but when workforce shortages are this acute, you start looking at solutions you'd have laughed at five years ago. UC San Diego researchers have already tested the G1 across seven medical procedures including ultrasound, intubation and auscultation via teleoperation. We're not quite at robot nurses. But we're not quite not at robot nurses either. Sleep well.
Something new is coming to Pigeon.
Next week, I’m launching Pigeon Insider - a fortnightly deep-dive that goes way beyond the headlines.
Every other week, subscribers to Insider will get a longer piece that:
Breaks down a market signal before the rest of the industry catches on
Unpacks a founder-operator story with the honesty that polished PR strips out
Takes an editorial position on something I think matters and nobody’s saying
This isn’t another newsletter. It’s the bit of Pigeon I’ve been wanting to write for five years - the analysis, the pattern recognition, the “here’s what I’m actually thinking” that doesn’t fit into the weekly roundup.
If you’re a founder trying to read the market, an investor looking for signal over noise, or an operator who’s tired of surface-level healthtech commentary, Insider is built for you.
More details next week. For now, just know… Pigeon is about to get a lot more interesting.
James ✌🏼
What to listen to 🔊
Why is medicine 150 years behind in understanding the role of humans in healthcare? I sat down with Dr David Neal, Assistant Professor at Amsterdam UMC and co-lead of the eHealth Living & Learning Lab (ELLLA) to dive in, as well as chatting about what happens when technology disrupts a healing ritual that hasn't fundamentally changed since the 16th century. Some big questions answered in this one…
From a remarkably blunt public warning by NHS England's own tech committee chair about leadership voids and unmitigated cyber risk, to why EPR systems that cost £40m still have staff logging into seven different screens. Plus the AVT market, the NHS app's rebrand as your "lifelong digital companion," and why clunky systems are costing as much staff time as sick leave. Well worth a listen.
Events 📅
RADIANT-CERSI Impact Showcase Event
📅 16th April
🇬🇧Brunel University London
This showcase will bring together the partners, funders, academics, and industry partners who have been part of the work RADIANT are doing to make the regulation of digital health and AI products more navigable, evidence-based, and fit for the pace of innovation.
DMEA 2026
📅 21–23rd April
🇩🇪 Messe Berlin, Germany
Europe's leading digital health event - around 900 exhibitors, 20,500+ visitors and 470 speakers across three days. If you're building, selling or buying healthtech on the continent, this is where the conversations happen.
BioSolutions UK
📅 21st April
🇬🇧 Glaziers Hall, London
Engineering biology meets industry - covers the biotech you know and love as well as food, agriculture, chemicals, materials, environment and biofuels. Startups, scale-ups, investors and policymakers in one room. Good if you're building at the intersection of biotech and the bioeconomy.
The Future of Medical Grade Wearables
📅 23rd April
🇬🇧Royal Society of Medicine, London
Explore how wearable technologies and bio-sensors are transforming health monitoring, clinical care, and creating powerful tools that improve patient outcomes.
Hardian Health Tech Summit 2026
📅 29th April
🇬🇧BMA House, London
The annual Hardian Health Tech Summit is bigger than ever! Join leading voices from the Medicines and Healthcare products Regulatory Agency, US Food and Drug Administration, NICE and industry innovators as they share real-world insights on getting regulatory-authorised healthtech to market.
Opportunities 🕵️♀️
🚀 Head of UK Customer Delivery, Lyrebird Health: A wise (spider)man once said “with great power comes great responsibility” and this role embodies the phrase perfectly - you’ll be in charge of customer delivery across the entire UK. The means building, leading and scaling the UK delivery engine from the ground up. Up for the challenge?
🧑💻 Senior Consultant - Software Quality Assurance, Hardian Health: If you know your IEC 62304 from your ISO 14971, have a passion for quality assurance and cutting-edge medical device software, you absolutely want to apply for this role at Hardian Health, the go-to consultancy for getting AI and software medical devices through regulatory clearance.
📱Head of Product, Patchwork Health: If you think you have what it takes to translate Patchwork’s product vision for multiple products into reality and build the system that builds the products, apply today!
🖥️ Strategy Principle Consultant, Feebris: This is a customer-facing role, perfect for someone from a consulting or transformation background who wants to move closer to commercial outcomes and take ownership of seeing all that hard strategic work convert into real-world adoption.
📣 NIHR Survey: Why Aren’t More Medical Technologies Designed for Children: Only 0.5% of FDA-approved orthopaedic devices were designed for children, just 2% of approved AI radiology tools are labelled for paediatric use, and a meagre 5% of the UK’s national research budget goes to paediatrics. The NIHR HealthTech Research Centre in Paediatrics and Child Health wants to understand why - and they need to hear from you (the industry). If you work in healthtech or medtech (even if your focus is entirely adult populations), this short survey asks what the real barriers are to building for children and young people. The data will directly inform how the gap gets addressed. Takes five minutes. Worth it.
James’ editor notes:
I’m pretty excited about launching Pigeon Insider next week. There’s so much we can do with Pigeon for the healthtech space, so fingers crossed it adds value and we can get a flywheel going.
I’ve covered off Jay Z (#280) and Eminem (today) so far in the Pigeon titles. DM me if you have other millennial rap inspiration 😂
If you want something in Pigeon, things get a lot of views and clicks - this is direct distribution to the healthtech space, so check out those links if you want to put things in.
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See you next week, Pigeon fans ✌🏼
One of the best reads in substack! Keep up the great work.