The high-risk wellness paradox of brain-stimulation wearables
Under EU MDR, a brains-stimulation headset treating depression is Class IIa. The same headset marketed for focus or relaxation, with no medical claim at all, is Class III — the highest risk tier there is. A look at the regulation behind this inverted logic.
Wearables in the race for ovulation accuracy
While a lawsuit questions Oura's sleep-tracking claims, its ovulation-prediction accuracy is quietly outperforming expectations — and so are Apple's and Huawei's. None of them hold medical device status for it. Natural Cycles does but has not published such data. What that gap actually reveals about evidence strategy for FABMs medtech vs wellness products.
China's health tech is a decade ahead; synergise, don’t reinvent the wheel
China's health tech is a decade ahead in ways the West hasn't caught up to yet — AI-designed hospital workflows, scarless surgery, full IoT hospital monitoring — alongside a population still deeply rooted in Traditional Chinese Medicine. A Shanghai summit, and the investor bridging China and the West in women's health.
Medicines are “essential goods”, why not devices?
Medicines get reduced VAT as "essential goods," devices don't. A look at how Swissmedic's funding gap traces back to 2002 and 2021.
DIY-ing the eclipse, DIY-ing health
A CD, polarised sunglasses, and a homemade risk assessment — what DIY-ing the 2026 eclipse taught me about how we all DIY our own healthcare too.
Eight teams at the edge of continuous hormone monitoring
From aptamer sensors to a fully implantable biochemical device — meet the 8 teams selected for SPRIND's €40M Continuous Hormone Monitoring Challenge.
Inside SPRIND’s jury for Continuous Hormone Monitoring
From wearable bioelectronics to metabolic research to decades of clinical obstetrics — the jury for SPRIND's Continuous Hormone Monitoring Challenge brings together an unusually wide range of expertise. Here's who's in the room, and where Edge Compliance fits in to assess regulatory strategy.
SPRIND's Continuous Hormone Monitoring Challenge open for applications
Hormones drive nearly every process in the body, yet we still measure them with single static snapshots. SPRIND's €40M Continuous Hormone Monitoring Challenge is funding sensor technology to change that — and I'll be on the jury selecting the founding teams. Here's what they're building, and why.
On "human in the loop" and automation bias
A widely circulated exchange about AI and military targeting raises a question every QARA professional should sit with: does "a human makes the final decision" really resolve anything when review time is a glance? Plus what's missing from the EU AI Act's high-risk categories, and new Commission guidance for health AI.
FDA's first AI-misuse warning letter wasn’t so much about AI
Purolea Cosmetics Lab's FDA warning letter made headlines as the first to cite AI misuse in manufacturing. But strip away the AI angle and the real story is a quality unit that had already collapsed. Part 3 closes a series on why AI regulation isn't leveling the playing field — yet.
Top nominated!
A year of weekly LinkedIn posts on medtech regulation just earned a "top new voice" nod — and it's got me thinking about why manual, deliberately human writing still cuts through an increasingly AI-saturated feed. Plus my personal top-10 list of medtech voices worth following.
The EU AI Act's postponement rewards those who never started
The EU AI Act's high-risk deadline just moved to December 2027. Under Article 111's grandfather clause, companies that never started compliance may get a permanent pass, while those who invested early carry the cost. Part 2 of a series on the disparity AI regulation is creating.
Notes from Scarlet's digital health summit
A day of genuinely open debate on digital health regulation: why the risk of not approving a solution deserves as much weight as the risk of approving one, what duty of care looks like at consumer-platform scale, and whether continuous deployment can ever fit inside traditional regulatory review.
LLMs for health advice get separate treatment
Over 5% of all ChatGPT messages are health-related, and 40 million people ask it health questions daily — yet it isn't regulated as a medical device, while purpose-built health apps are. Part 1 of a three-part series on why AI regulation creates disparity, not just innovation.
New Zealand: an under-explored SaMD frontier
New Zealand still regulates medical devices under a 1981 law never built for software — meaning most low-risk SaMD can reach market today with a simple, free notification and no pre-market review. Here's what that window looks like, how long it lasts, and why it pairs naturally with Australia.
Australia as a first GTM for SaMD
Australia's TGA released fresh SaMD guidance in early 2026 — and it's a case study in what good regulation can look like: plain-language self-assessment, genuine low-risk carve-outs, and enforcement that actually backs the framework. Here's why it's often my recommended first market for digital health founders.
One year in, and incorporating
A year into full-time self-employment, I'm incorporating a Swiss GmbH to house two ventures: Edge Compliance's regulatory work for femtech startups, and Onya Health's early bet on reducing birth trauma through better labour planning. Here's what year one actually looked like, in numbers.
The price tag on being a woman
Menstruation costs the average person £20,359 over a lifetime — before contraception, birth, or menopause even enter the picture. Layered onto a persistent gender pay gap, this isn't a private budgeting problem. It's a structural cost that deserves the same scrutiny as any other health inequity.
Translating your device into "regulatorese"
Struggling to translate your device into "regulatorese"? Our collaborator Erica Perrier of Evidentia Consulting built a free AI tool around three deceptively simple questions — what does it do, who is it for, how does it work. I tested it on fertility devices: here's what it nailed, what it missed, and why those three questions matter more than they sound.
Optimised for the optimised
Health tech has never had more data or more capital — yet population health outcomes haven't moved. This article looks at why the wellness-to-medical staged strategy is harder than it looks, and what regulation, funding data, and public health theory tell us about who we're actually building for.