FDA and patent law create dual hurdles for AI-enabled medical technologies

AI reshapes healthcare by powering more precise and adaptive medical devices and diagnostic systems.

Yet, innovators face two significant challenges: navigating the US Food and Drug Administration’s evolving regulatory framework and overcoming legal uncertainty under US patent law.

These two systems, although interconnected, serve different goals. The FDA protects patients, while patent law rewards invention.

The FDA’s latest guidance seeks to adapt oversight for AI-enabled medical technologies that change over time. Its framework for predetermined change control plans allows developers to update AI models without resubmitting complete applications, provided updates stay within approved limits.

An approach that promotes innovation while maintaining transparency, bias control and post-market safety. By clarifying how adaptive AI devices can evolve safely, the FDA aims to balance accountability with progress.

Patent protection remains more complex. US courts continue to exclude non-human inventors, creating tension when AI contributes to discoveries.

Legal precedents such as Thaler vs Vidal and Alice Corp. vs CLS Bank limit patent eligibility for algorithms or diagnostic methods that resemble abstract ideas or natural laws. Companies must show human-led innovation and technical improvement beyond routine computation to secure patents.

Aligning regulatory and intellectual property strategies is now essential. Developers who engage regulators early, design flexible change control plans and coordinate patent claims with development timelines can reduce risk and accelerate market entry.

Integrating these processes helps ensure AI technologies in healthcare advance safely while preserving inventors’ rights and innovation incentives.

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Google Research applies AI across cancer, quantum computing and Earth science

Google Research has outlined how it tackles three major domains where foundational AI and science research are applied for tangible global effect, under a framework the team calls the ‘magic cycle’.

The three focus areas highlighted are fighting cancer with AI, quantum computing for medicines and materials, and understanding Earth at scale with Earth AI.

One of the flagship tools is DeepSomatic, an AI system developed to detect genetic variants in cancer cells that previous techniques missed. The tool partnered with a children’s hospital to identify ten new variants in childhood leukaemia samples. Significantly, DeepSomatic was applied to a brain cancer type it had never encountered before and still flagged likely causal variants.

Google Research is exploring the frontiers with its service chip (Willow) and algorithms like Quantum Echoes to simulate molecular behaviours with precision that classical computers struggle to reach. These efforts target improved medicines, better batteries and advanced materials by capturing quantum-scale phenomena.

Aiming to model complex interconnected systems, from weather and infrastructure to population vulnerability, the Earth AI initiative seeks to bring disparate geospatial data into unified systems. For example, predicting which communities are most at risk in a storm requires combining meteorological, infrastructure and socioeconomic data.

Google Research states that across these domains, research and applied work feed each other: foundational research leads to tools, which, when deployed, reveal new challenges that drive fresh research, the ‘magic cycle’.

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AMD powers US AI factory supercomputers for national research

The US Department of Energy and AMD are joining forces to expand America’s AI and scientific computing power through two new supercomputers at Oak Ridge National Laboratory.

Named Lux and Discovery, the systems will drive the country’s sovereign AI strategy, combining public and private investment worth around $1 billion to strengthen research, innovation, and security infrastructure.

Lux, arriving in 2026, will become the nation’s first dedicated AI factory for science.

Built with AMD’s EPYC CPUs and Instinct GPUs alongside Oracle and HPE technologies, Lux will accelerate research across materials, medicine, and advanced manufacturing, supporting the US AI Action Plan and boosting the Department of Energy’s AI capacity.

Discovery, set for deployment in 2028, will deepen collaboration between the DOE, AMD, and HPE. Powered by AMD’s next-generation ‘Venice’ CPUs and MI430X GPUs, Discovery will train and deploy AI models on secure US-built systems, protecting national data and competitiveness.

It aims to deliver faster energy, biology, and national security breakthroughs while maintaining high efficiency and open standards.

AMD’s CEO, Dr Lisa Su, said the collaboration represents the best public-private partnerships, advancing the nation’s foundation for science and innovation.

US Energy Secretary Chris Wright described the initiative as proof that America leads when government and industry work together toward shared AI and scientific goals.

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Qualcomm and HUMAIN power Saudi Arabia’s AI transformation

HUMAIN and Qualcomm Technologies have launched a collaboration to deploy advanced AI infrastructure in Saudi Arabia, aiming to position the Kingdom as a global hub for AI.

Announced ahead of the Future Investment Initiative conference, the project will deliver the world’s first fully optimised edge-to-cloud AI system, expanding Saudi Arabia’s regional and global inferencing services capabilities.

In 2026, HUMAIN plans to deploy 200 megawatts of Qualcomm’s AI200 and AI250 rack solutions to power large-scale AI inference services.

The partnership combines HUMAIN’s regional infrastructure and full AI stack with Qualcomm’s semiconductor expertise, creating a model for nations seeking to develop sovereign AI ecosystems.

However, the initiative will also integrate HUMAIN’s Saudi-developed ALLaM models with Qualcomm’s AI platforms, offering enterprise and government customers tailor-made solutions for industry-specific needs.

The collaboration supports Saudi Arabia’s strategy to drive economic growth through AI and semiconductor innovation, reinforcing its ambition to lead the next wave of global intelligent computing.

Qualcomm’s CEO Cristiano Amon said the partnership would help the Kingdom build a technology ecosystem to accelerate its AI ambitions.

HUMAIN CEO Tareq Amin added that combining local insight with Qualcomm’s product leadership will establish Saudi Arabia as a key player in global AI and semiconductor development.

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Two founders turn note-taking into an AI success

Two 20-year-old drop-outs, Rudy Arora and Sarthak Dhawan, are behind Turbo AI, an AI-powered notetaker that has grown to around 5 million users and reached a multi-million-dollar annual recurring revenue (ARR) in a short timeframe.

Their app addresses a clear pain point, which is that meetings, lectures, and long videos produce information overload. Turbo AI uses generative AI to convert audio, typed notes or uploads into structured summaries, highlight key points and help users organise insights. The founders describe it as a ‘productivity assistant’ more than a general-purpose chat agent.

The business model appears lean, meaning that freemium user acquisition is scaling quickly, then converting power users into paid subscriptions. The insights are that a well-targeted niche tool can win strong uptake even in a crowded productivity-AI market.

Arora and Dhawan say they kept the feature set focused and user experience simple, enabling rapid word-of-mouth growth.

The growth raises interesting implications for enterprise and consumer AI alike. While large language models dominate headlines, tools like Turbo AI show the value of vertical-specific applications addressing tangible workflows (e.g., note-taking, summarisation). It also underscores how younger founders are building AI tools outside the major tech hubs and scaling globally.

At this stage, challenges remain: user retention, differentiation in a field where major players (Microsoft, Google, OpenAI) are adding similar capabilities, and privacy/data governance (especially with audio and meeting content). However, the early results suggest that targeted AI productivity tools can achieve a meaningful scale quickly.

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AI tool Mirror keeps track of medical information

A new app called Mirror, developed by Oxford-based company Aide Health, aims to help patients remember and summarise information from medical appointments using AI. The platform records consultations and produces summaries that patients can refer back to or share with family and carers.

Creator Ian Wharton said the idea came from helping his father, who has early-stage Alzheimer’s, to recall essential details from doctors’ visits. The app listens passively during appointments and produces a clear summary of what was discussed, making it easier for patients to retain key information.

Early users have praised the platform for making consultations easier to manage. One described being able to share concise summaries with friends and colleagues, saving the effort of repeating complex medical details. The creator added that patient data is private and not shared with third parties.

The current version works during in-person consultations, but future updates will allow the app to actively prompt patients with reminders or questions, advocating for their healthcare needs.

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UN cybercrime treaty signed in Hanoi amid rights concerns

Around 60 countries signed a landmark UN cybercrime convention in Hanoi, seeking faster cooperation against online crime. Leaders cited trillions in annual losses from scams, ransomware, and trafficking. The pact enters into force after 40 ratifications.

UN supporters say the treaty will streamline evidence sharing, extradition requests, and joint investigations. Provisions target phishing, ransomware, online exploitation, and hate speech. Backers frame the deal as a boost to global security.

Critics warn the text’s breadth could criminalise security research and dissent. The Cybersecurity Tech Accord called it a surveillance treaty. Activists fear expansive data sharing with weak safeguards.

The UNODC argues the agreement includes rights protections and space for legitimate research. Officials say oversight and due process remain essential. Implementation choices will decide outcomes on the ground.

The EU, Canada, and Russia signed in Hanoi, underscoring geopolitical buy-in. Vietnam, being the host, drew scrutiny over censorship and arrests. Officials there cast the treaty as a step toward resilience and stature.

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EU MiCA greenlight turns Blockchain.com’s Malta base into hub

Blockchain.com received a MiCA license from Malta’s Financial Services Authority, enabling passported crypto services across all 30 EEA countries under one EU framework. Leaders called it a step toward safer, consistent access.

Malta becomes the hub for scaling operations, citing regulatory clarity and cross-border support. Under the authorisation, teams will expand secure custody and wallets, enterprise treasury tools, and localised products for the EU consumers.

A unified license streamlines go-to-market and accelerates launches in priority jurisdictions. Institutions gain clearer expectations on safeguarding, disclosures, and governance, while retail users benefit from standardised protections and stronger redress.

Fiorentina D’Amore will lead the EU strategy with deep fintech experience. Plans include phased rollouts, supervisor engagement, and controls aligned to MiCA’s conduct and prudential requirements across key markets.

Since 2011, Blockchain.com says it has processed over one trillion dollars and serves more than 90 million wallets. Expansion under MiCA adds scalable infrastructure, robust custody, and clearer disclosures for users and institutions.

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Japan’s G-QuAT and Fujitsu sign pact to boost quantum competitiveness

Fujitsu and AIST’s G-QuAT have signed a collaboration to lift Japan’s quantum competitiveness, aligning roadmaps, labs, and funding toward commercialisation. The pact focuses on practical outcomes: industry-ready prototypes, interoperable tooling, and clear pathways from research to deployment.

The partners will pool superconducting know-how, shared fabs and test sites, and structured talent exchanges. Common testbeds will reduce duplication, lift throughput, and speed benchmarks. Joint governance will release reference designs, track milestones, and align on global standards.

Scaling quantum requires integrated systems, not just faster qubits. Priorities include full-stack validation across cryogenics and packaging, controls, and error mitigation. Demonstrations target reproducible, large-scale superconducting processors, with results for peer review and industry pilots.

G-QuAT will act as an international hub, convening suppliers, universities, and overseas labs for co-development. Fujitsu brings product engineering, supply chain, and quality systems to translate research into deployable hardware. External partners will be invited to run comparative trials.

AIST anchors the effort with the national research capacity of Japan and a mission to bridge lab and market. Fujitsu aligns commercialization and service models to emerging standards. Near-term work packages include joint pilots and verification suites, followed by prototypes aimed at industrial adoption.

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Diella 2.0 set to deliver 83 new AI assistants to aid Albania’s MPs

Albania’s AI minister Diella will ‘give birth’ to 83 virtual assistants for ruling-party MPs, Prime Minister Edi Rama said, framing a quirky rollout of parliamentary copilots that record debates and propose responses.

Diella began in January as a public-service chatbot on e-Albania, then ‘Diella 2.0’ added voice and an avatar in traditional dress. Built with Microsoft by the National Agency for Information Society, it now oversees specific state tech contracts.

The legality is murky: the constitution of Albania requires ministers to be natural persons. A presidential decree left Rama’s responsibility to establish the role and set up likely court tests from opposition lawmakers.

Rama says the ‘children’ will brief MPs, summarise absences, and suggest counterarguments through 2026, experimenting with automating the day-to-day legislative grind without replacing elected officials.

Reactions range from table-thumping scepticism to cautious curiosity, as other governments debate AI personhood and limits; Diella could become a template, or a cautionary tale for ‘ministerial’ bots.

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