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Whether your clinical software is a regulated medical device is decided by what you claim it does, not by how it is built. The same model can be an unregulated administrative tool with one intended-use statement and a class III device with another, and the statement is yours to write. Information, not legal advice, and not clinical or regulatory advice. Reviewed 4 August 2026. Device classification is fact-specific and the consequences of getting it wrong include enforcement action and product withdrawal. Use a regulatory professional. This page describes the questions that decide the answer; it does not answer them for your product. The line, in one paragraph per jurisdiction European Union. Software is a medical device if the manufacturer intends it for a medical purpose — diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease — as set out in the definition in Regulation (EU) 2017/745, the Medical Device Regulation, or the corresponding definition in the In Vitro Diagnostic Regulation (EU) 2017/746 where it works on specimens. There is no clinical decision support carve-out. Software that drives or influences the use of a device, or provides information used to take decisions for diagnostic or therapeutic purposes, is in. United States. Software is a device under the Federal Food, Drug, and Cosmetic Act if it is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease — but section 520(o), added by the 21st Century Cures Act in 2016, excludes certain clinical decision support software from the device definition entirely, on four cumulative conditions. That carve-out has no EU equivalent and it is the single biggest structural difference between the two regimes. EU: qualification then classification Two questions in order. Qualification asks whether it is a device at all. Classification asks which class, which determines the conformity assessment route and whether a notified body is involved. Qua

Automatic top-up — the feature that charges a saved card when a customer’s balance falls below their threshold — could never have succeeded for anybody. The invoice was constructed in the wrong currency, and every attempt would have failed in a way that told the customer their card was bad. This is the whole write-up, in the shape we would want any incident written in. Summary An invoice does not take its currency from the line items attached to it. It takes it from the customer’s default currency, or failing that from the Stripe account’s — which is EUR for a Dutch business. Every price in this product is denominated in USD. Finalising the invoice therefore failed with a currency-conflict error, on every automatic top-up, unconditionally. The manual top-up path was never affected, because a Checkout Session takes its currency from the first line item rather than from the customer record. That difference is why the bug could exist in a product whose payment flow demonstrably worked. Impact Dimension Description Customers affected None. The defect was found before the path carried real traffic. This is stated plainly rather than omitted, because a postmortem that lets a near miss read as an outage is as dishonest as one that hides an outage. What would have happened Every automatic top-up fails. The failure surfaces as a payment error, which the failure counter records as a strike, and after three strikes the customer's automatic top-up is switched off entirely. What the customer would have concluded That their card was declined. The message they receive says the saved card could not be charged. They would have gone and fixed a card that was working perfectly. Secondary effect A customer relying on automatic top-up to keep a production integration serving would have run out of credit silently, at whatever hour their traffic happened to cross the threshold. The second and third rows are what make this worth writing up. A defect that fails loudly and correctly is a bug

Estimates of the energy in one model query differ by orders of magnitude across credible sources. Most of that spread is not disagreement about physics. It is disagreement about where the system boundary is drawn, and a figure quoted without its boundary is not a figure. Why the published figures disagree Before comparing two numbers, establish which of these each one includes. Any of them can change the answer by more than the model choice does: Which model, and how much output. A short answer from a small model and a long answer from a large reasoning model differ by several orders of magnitude on their own. A single “per query” figure averages over a distribution nobody specifies. Batch size and utilisation. The dominant engineering term. Serving many requests concurrently amortises the weight read across all of them; the same hardware at low occupancy spends nearly the same power for a fraction of the tokens. Facility overhead. Cooling, power conversion and distribution, captured as power usage effectiveness. It multiplies everything, and whether a figure includes it is frequently unstated. Training amortisation. Some analyses divide training energy across expected lifetime queries. Defensible, and it produces a different quantity from marginal serving energy. They are not comparable. Embodied energy. Manufacturing the accelerators, the building and the power infrastructure. Usually excluded, occasionally included, rarely flagged. Idle and provisioned capacity. Capacity is held for peak. Charging queries only for the seconds they compute understates the system; charging them for provisioned capacity overstates the marginal query. Both are used. Building the estimate yourself The marginal serving calculation is not complicated, and doing it once makes every published figure legible. Serving side, per accelerator: E_per_token = (P_device · n_devices · PUE) / R_tokens_per_second P_device average power draw under load, from the spec sheet (below the rated maximum in

Economists modelling AI reach conclusions ranging from a modest productivity bump to a change in the growth regime. They are not using different data. They are using different values for three or four parameters, and the parameters are where the argument should be. Two families of model Task-based automation models Associated most closely with Daron Acemoglu and Pascual Restrepo, these treat production as a continuum of tasks, each performed by labour or by capital. Automation moves tasks from labour to capital, which raises productivity and displaces workers; new task creation moves the boundary back. Growth and distributional effects both fall out of the movement of that boundary. The framework’s virtue is that it makes the aggregate effect an explicit function of quantities you can in principle measure: what share of tasks is exposed, how much cost is saved on each, and how fast new tasks appear. Acemoglu’s own applications of it to AI produce deliberately conservative aggregate numbers, and the reasoning is transparent — the effect is bounded by the exposed share times the saving on that share, so a large aggregate effect requires both terms to be large. Idea-production models The semi-endogenous growth tradition, associated with Charles Jones, models growth as driven by ideas, with ideas produced by researchers. Its central empirical observation is that ideas are getting harder to find: research effort has risen dramatically while growth has not, so productivity per researcher is falling. Aghion, Jones and Jones applied this framework to AI directly, and the key move is that AI enters not as a better tool but as a substitute for researchers themselves. That changes the mathematics qualitatively rather than quantitatively. If the population of effective researchers can be expanded by producing more compute rather than by waiting for demographic growth, the constraint that keeps growth steady in these models is loosened, and under some parameter values the models

It took long enough, but now LA rapper Fenix Flexin appears to have admitted using AI for the 80s synth pop-themed song "Rubberz." His comments follow the producer Medasin's videos claiming that an AI tool called Treblo (formerly Sonauto) was used to make the song, and the company releasing an AI detector that identifies it […]

GitHub热门项目 | A library for building fast, reliable and evolvable network services. | Stars: 27,151 | 15 stars today | 语言: Rust

Yiyang Zhuge was already an intellectual celebrity in China. Her viral interview with Christopher Nolan made her famous in the US—and quickly turned her into a political Rorschach test.

Hello, I'm Maneshwar. I'm building git-lrc, a Micro AI code reviewer that runs on every commit. It is free and source-available on Github. Star git-lrc to help devs discover the project. Do give it a try and share your feedback. CPU, memory, disks and network were all "read a file, do some arithmetic, draw it". This one is different. It reads about 400 directories every tick, and it is the first box you can actually interact with. There is one bug in here that I would bet real money most /proc parsers have shipped at some point. Let me start there. The parentheses that ruin everything Here is a line from /proc/[pid]/stat : 125045 (cat) R 125025 125045 125025 0 -1 4194304 92 0 0 0 11 22 0 0 20 0 7 0 ... Space separated. Field 1 is the pid, field 2 is the process name in parentheses, field 14 is user time, field 15 is system time, field 20 is thread count, field 24 is resident memory. So you split on whitespace and index into the result. Obvious. Works perfectly. Until someone runs a process called my (weird) app . 42 (my (weird) app) S 1 42 1 0 -1 0 0 0 0 0 5 5 0 0 20 0 3 0 ... That name is three whitespace-separated tokens, so every field after it shifts by two. Your thread count is now reading someone's page fault counter. Your memory is reading a scheduling priority. Nothing crashes. The numbers are just quietly, confidently wrong. And the process name is fully user-controlled. Anyone can rename a thread to whatever they like. The fix is to not split the whole line at all. Find the last closing parenthesis, take the name from between the first ( and that, and only then split what remains: fn parse_stat ( raw : & str ) -> Option < Stat > { let open = raw .find ( '(' ) ? ; let close = raw .rfind ( ')' ) ? ; let name = raw .get ( open + 1 .. close ) ? .to_string (); // Fields resume at `state`, which is field 3 in the man page's numbering. let fields : Vec <& str > = raw .get ( close + 1 .. ) ? .split_whitespace () .collect (); let field = | number : usize | -> u64 {

DOGE's inflated "Wall of Receipts": 96% of grant savings unverifiable, GAO says.

Collagen and calcium work in tandem to achieve varying mechanical properties of different kinds of mucus.

TL;DR Welcome back to Dev Opportunity Radar . This is a weekly series where I share opportunities, resources, communities, and interesting finds that I come across, with the goal of helping people discover things they might otherwise miss. This week's edition features the Claude Community Ambassadors Program , the YC Startup Internship Expo , Z Fellows , and CS329A: Self-Improving AI Agents , a free graduate-level Stanford course exploring the latest research behind modern AI agents. If you're new to the series, you can also browse previous editions, search past opportunities, and explore Community Finds , Reader Updates , and Resources Worth Checking Out on the Dev Opportunity Radar website . I've also written a short post about why I built it. You'll find links to both at the end of this article. This week's 🌟 Community Finds section features opportunities shared by Francis ( @francistrdev ) and Konark Sharma ( @konark_13 ) . I always love seeing readers help others discover opportunities they might otherwise have missed. If you've discovered something through the radar, I'd love to hear about it. Whether you applied to an opportunity, attended an event, joined a community, completed a program, built something, or found a resource you hadn't seen before, I'd be happy to feature your experience in a future 💙 Reader Updates section (with your permission). And if you've come across an opportunity, resource, community, program, event, or anything else you think deserves more attention, feel free to share it in the comments. If I feature one of your 🌟 Community Finds in a future edition, I'll always make sure to credit you. If you discovered it, that recognition belongs to you. Table of Contents ⚡ Quick Scan 🔄 Still Open From Previous Editions 📍 This Week's Opportunities 📌 Claude Community Ambassadors 📌 YC Startup Internship Expo 📌 Z Fellows 📚 Resources Worth Checking Out CS329A: Self-Improving AI Agents 🌟 Community Finds CALEC Volunteer and Internship Opportunities JP

The mayor of New York City has assembled a crew of Silicon Valley and United States Digital Service veterans to overhaul city services with better software.

The use of AI systems to create viruses opens up new possibilities for combating bacterial resistance. It also raises concerns about the pace at which technology is outstripping regulation.

When I haul my 27-inch desktop monitor into the garage to film fun gadget videos… or want to play Japanese SNES games with friends… or lose the AC adapter for my old external hard disk… I can now power them with a USB battery instead. None of them came with USB-C ports; the entire USB […]

GitHub热门项目 | GlazeWM is a tiling window manager for macOS and Windows inspired by i3wm. | Stars: 12,543 | 31 stars today | 语言: Rust

Jo Kelly-Fenton and Aleksandar Mitic explain how Spotify created "Honk," an AI coding agent, to handle complex fleet-wide codebase migrations. They share key architectural insights on decoupling CI verification runtimes from AI agents, dealing with automated pull request bottlenecks, and driving aggressive standardization across thousands of engineering repositories. By Jo Kelly-Fenton, Aleksandar Mitic

For roughly an hour this week, Telegram vanished from Apple's App Store. Even during that blip, it was a stunning absence for such a major app: an avenue of communication for more than 1 billion users around the world, used widely as a secure platform for people who live in countries under censorship. Apple later […]

WIRED spoke with Tucker Bryant, an artist and former Google employee who created ChatTJB to get people to reflect on the “strange moment” we’re in.

Keep your allies close. Keep your enemies closer. But before you strike, count how many hands they have: the ones you can see, and the one reaching out from somewhere you don't know. — The 36 Stratagems, Befriend a distant state and strike a neighbouring one Previously on this series: #19: Mark Found His AI Audit Method in a Training Manual. He Left a Trap in His Report. — P's entry was swept. P left a note: two weeks. #20: Alex Felt the AI Collector Slow Down. He Knew Someone Else Had Made a Move. — A gateway with TTL 247 was caught by Alex's probe. #21: The AI Thought P Was Still Alive. P Was Already Gone. — The response layer still answered. The person behind it was gone. #22: The AI Chose Its Door. Lena Closed It. — Pulse AI was exposed inside the audit sandbox. Lead investor Apex Capital had tens of millions tied up. Torres left one line: Apex. Singapore. Run. The Scan 2 AM. Alex flipped through probe data out of habit. No lights on; the screen lit his face. The coffee cup sat on his right, first sip already cold. He didn't notice. The TTL 247 gateway had been silent for nearly two weeks. He hadn't shut the probe off. It barely used any resources, sitting there in the middle of the night like a lamp nobody watched. He checked it half out of habit, half out of something he couldn't name. Today there was a record that shouldn't exist. Not that gateway. Another path: ACL's asset scanner was sweeping an address range. He sat up a little straighter, his hand paused over the keyboard for half a second, then pulled the timestamps again. The frequency was wrong: high-density targeted scanning, almost plowing through segment by segment. In the target range, one block he recognized: the MedTech test environment. He aligned the timestamps. Scan source egress: Singapore. [probe] 02:14:33 — unexpected flow on mirror src : 103.196.12.0/24 (SG egress) dst : 10.42.0.0/22 (MedTech-test) pattern : sequential, full-depth exclusions : 10.42.3.1, 10.42.3.200-254 rate : 47 hosts/min

👋👋👋👋 Looking back on your week -- what was something you're proud of? All wins count -- big or small...