#306: Not a medical device, apparently
The one-minute weekly healthtech roundup, by SomX
Hello healthtech world.
As if you thought SomX Healthtech Talks couldnāt get any better, we asked ourselves what the spiciest debate could possibly be and, TLDRā¦ Iām interviewing the Rt Hon. Sir Jeremy Hunt on a panel on 2nd September.
More details in the events section towards the end of this email, but if you canāt even wait until then, hit that to register interest in coming šš¼
Onto some healthtech news. Itās AI heavy, but thatās life. Donāt shoot the messenger š¤·š»āāļø
James šš¼
News Bites š„Ŗ
šļø The MHRA says your AI scribe isn't a medical device: This is causing waves online (understandably). If youāre in the UK, apparently itās about the intended use, not the technologyā¦ If you transcribe, summarise, structure, code, draft discharge letters, thatās all fine. But offer "generated insights" with suggested diagnoses, or let an agent order tests without a clinician looking, and you're class IIa.. For me, this is an odd one. Summarisation is a clinical judgement - youāre deciding what matters and what doesnāt, so itās bizarre to me that hasnāt been recognised as medical device activity and itās convenient that it opens the UK to the all the big platforms we talk about on here regularly to flick a switch and wipe out the small companies. The MHRA also stuck a ānot legally bindingā disclaimer at the top, which it doesnāt usually do, so read into that what you willā¦
š¤ T-Pro buys BigHand Healthcare: Now, with that šš¼ in mind, a clinical documentation platform has acquired a workflow orchestration provider, which, I hear you, is absolutely not a Hollywood film idea, BUT itās a signal of whatās happening at the big, boring, āactually-have-moneyā end of healthtech. T-Pro is the Dublin dictation outfit thatās been in NHS trusts since 2012 (now 120 of them and around 200 staff). Tortus, Heidi, Tandem and friends all built the ambient product first and are now grinding through procurement to add customers. T-Pro already has the customers and is now buying everything elseā¦ Going that way round is arguably a lot easier.
š„¼ 40% of TikTokās top health videos are hosted by doctors who donāt exist: 1,198 videos were analysed and there was AI-generated content in 40% of the top health clips (rising to 84% for āhealth tipsā). Average views on the top synthetic doctor videos were 2.5 million! Classic nonsense like Coca-Cola and onion for pain relief and NHS England, the BMA and the RCGP have all gone for the expected ādanger to public safetyā. How do you punish a fake doctor? Well you canāt GMC something that isnāt on the GMC register, so good luck. I actully covered this (and a load of other things in the media vs medicine melting pot) in Pigeon Insider this week. Hospitals are even fighting deepfakes of their own doctors being used to direct people to buying drugs online. B2C healthcare marketing is in trouble.
š§āāļø AI patients for real doctors: Sounds dystopian, but isn't, fortunately. Kent and Medway Mental Health NHS Trust is running an 18-month project with their local med school to use AI-generated virtual patient avatars to let third-year students practise psychiatric history-taking, communication and clinical reasoning before they meet anyone real. Med students are clearly already doing this and 100 variations on the theme and actors are lovelyā¦ but expensive and finite. So something formally developed with input from people with lived experience of mental illness is ideal.
šØ TidalSense raises Ā£14m to put a COPD breath test in NHS clinics: Good to see someone dragging lung diagnostics out of the 1800s. Itās the first non-spirometry AI diagnostic device to be CE-marked for COPD and it showed >90% precision compared to existing spirometry's 71% precision in primary care. Needs 75 seconds of normal breathing and no forced manoeuvre required. Money goes on NHS and international rollout, expanding into asthma, and building out commercial teams.
šŖšŗ Europe puts ā¬3.8m behind cross-border health data: Three projects picked from 19 proposals under the EU-funded UNITE programme. CARDIO-HUB is building a āCardio-Passportā so elderly heart failure patients can generate a standardised summary and share it with a clinician in another country. NEODATA+ is working on neonatal intensive care decision-making, and RAD-TRACK EU is tracking cumulative radiation exposure as patients move between imaging providers. UNITEās trying to force a shift from isolated pilots to full-scale deployment, the road to which is paved with the bones of many who have come before them. But Wales has joined UNITE with Ā£700k of its own, and thereās a route in for UK innovators, so thatās good.
šŗšø The US is paying nursing homes to get off paper: My Dad was a charge nurse for most of his career and in his retirement, infamously bought a nursing home. As the least trusting human being on earth when it comes to technology, he then took their brand new computer-based accounting system and painstakingly put it back all onto paper. Anyway, thankfully heās no longer in any position of authority in healthcare and now thereās new legislation and funding to go one further and help nursing homes and home health providers adopt EHRs. In the UK, our new PM seems to care about the social care system which is good. Iād tell him that the US are fixing theirs with money while we keep not fixing ours with strategies, so perhaps take a leaf etcā¦
And finallyā¦
Pigeon insider is the upgraded newsletter for those of you that want deep research and to steal fantastic ideas to sound incredibly smart in front of everyone else.
Media, influencers, advertising and healthcare. Thatās a box of frogs and an absolute disaster waiting to happen (already happening). I deep dive ASA rules, whoās breaking them, what healthtech companies can do to get ahead and what questions investors need to be asking before they put money in.
What to listen to š
This week I had the absolute legend, Yasir Sacranie, on the pod. Heās a pharmacist, content creator and founder of MicroPharm, the platform that continues to get thousands of trainee pharmacists through their registration exam.
This is epic. Tjasa talks to Emily Kate Genatowski, a historian who bought a humanoid robot and lived with it for over a year. Worth a listen if you've recently sat in a meeting where someoneās even slightly suggested that the social care workforce crisis is solved any time soon with robots.
Peter Birch recorded this one on the floor at BIO in San Diego, and the recurring theme is trial recruitment, which remains the bottleneck nobody has solved and everybody is now pointing AI at.
Given the MHRA news, if youāre interested, go back to my conversation with Jamie Cox, co-founder and CTO of Scarlet, which is Europe's only notified body specialising in software and AI medical devices (they certified TORTUS as UKCA Class IIa in June). Listening to it against this week's guidance is a slightly uncomfortable experience, but a very informative one.
Events š
Get ready for this one. Yes, thatās exactly who you think it isā¦
SomX Healthtech Talks: Will the NHS waste the AI moment?
šļø 2 September
š¬š§ Hale House, London.
Weāre back. And this time, weāre bringing the Rt Hon Sir Jeremy Hunt who served as Chancellor, Foreign Secretary and Secretary of State for Health and Social Care. Heās joined by myself (Dr James Somauroo), Tara Donnelly, one of the NHSās most respected digital leaders and former Chief Digital Officer at NHS England, and Jack Needham, cofounder of Sanctuary Health, bringing AI to the NHS. I want to get to the nub of where AI can tangibly make a difference in secondary care, where itāll disappoint, and what itāll actually take behind the scenes for the health service to truly seize the day. Expect Chatham House Rule, real opinions and stories never heard.
HealthVC Summit 2026
šļø 2-3 September
šØš Zurich.
Two days connecting health investors and founders across Europe, China and Saudi Arabia. If youāre raising, this is where the cheque-writers gather.
Mental Health Innovation Showcase, Hale House
š
15 September
š š¬š§ Hale House, London.
MHIN's showcase returns to the Harley Street Health District for a full day (noon to 9pm, so pace yourself) of mental health innovation. Given how much of this space still runs on vibes rather than evidence, worth your time.
Life Sciences Week 2026
šļø 21-25 September
š¬š§ Birmingham.
Britainās national life sciences week, pulling biotech, medtech, pharma, academia and investors into one place. A proper cross-sector convening rather than the usual echo chamber.
LSI Europe ā26 Emerging Medtech Summit
šļø 28 September-1 October
šŖšø Grand Hyatt Barcelona.
Europeās leading emerging-medtech investor summit, matching founders with VCs, PE and strategics. Sunny, well-connected, and squarely aimed at getting deals done.
TechBio UK 2026
š
13 October
š š¬š§ Kings Place, London.
The BIAās flagship TechBio conference, uniting biotech, pharma, tech and investment leaders.
Harley Street Health District Conference 2026
š
20 October
š š¬š§ 1 Wimpole Street, London.
A full-day conference from the district becoming one of Londonās biggest healthtech hubs.
Visit the SomX events page or subscribe to SomXās events roundup for everything else.
Opportunities š°
š„ The entire executive team, Online NHS Trust (England): Medical director, chief nurse, chief people officer and chief financial officer, all open at once, ahead of a 2027 launch. This is the NHSās first national digital-first trust, delivering planned care through the NHS App. You would be building an NHS organisation from a blank page, which happens roughly never. HTNās write-up here if you want the candidate brief detail first.
Health Tech World Awards 2026, (deadline 14 August): Eight sponsored categories including Leader of the Year, AI Innovation and Startup of the Year. Judging 17 August to 28 September, winners announced 5 October.
š HTN Now Awards 26/27: Open for entries. The Health Tech Awards 2026 are currently in judging, so that ship has sailed for this cycle so get your submissions in for the 2027 cohort now.
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See you next week, Pigeon fans āš¼
Healthtech Pigeon is produced by SomX - the media-led communications and creative agency for healthcare. We help healthtech, biotech, pharma and public sector organisations tell sharper stories through strategy, PR, content, design, events and media production. Built by clinicians, scientists and creatives who know the space. Work with us.