Andersen Med

𝐌𝐨𝐛𝐢𝐥𝐞 𝐁𝐥𝐨𝐨𝐝‑𝐏𝐫𝐞𝐬𝐬𝐮𝐫𝐞 𝐌𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭: 𝐀𝐩𝐩𝐬 𝐖𝐨𝐫𝐭𝐡 𝐘𝐨𝐮𝐫 𝐀𝐭𝐭𝐞𝐧𝐭𝐢𝐨𝐧 One of the most intriguing trends in healthcare is the rise of mobile applications for blood‑pressure monitoring. We’ve reviewed three popular solutions in this segment and looked at the evidence behind their effectiveness. Hello Heart works in tandem with an FDA‑approved cuff and mobile app, positioning itself as a digital therapeutic tool. Company‑sponsored studies showed encouraging results: in one cohort (≈28,000 participants in corporate insurance programs), over 80% of users with stage‑2 hypertension moved to a lower blood‑pressure category over three years, reducing it by about 20 mmHg [1]. A later analysis of ≈102,000 users found that those with a baseline systolic BP ≥140 mmHg reduced it by an average of 18.6 mmHg, alongside improvements in cholesterol and weight [2]. However, these are retrospective studies, and the app itself is not FDA‑approved. Also worth noting: there are no randomized clinical trials yet — and that matters. Qardio, Inc. is a chest‑worn ECG monitor that continuously records heart rhythms. The device received FDA clearance in 2021 and the CE mark in Europe. A small accuracy study showed good agreement with Holter monitoring results [3]. But peer‑reviewed data beyond this remain limited. While useful for collecting ECG data, there’s no research showing that its use improves clinical outcomes. OMRON Healthcare, Inc. is a companion app for Omron’s home blood‑pressure monitors, syncing readings, generating charts, and creating reports. The monitors themselves meet international accuracy standards [4]. A pilot randomized trial found that logging blood‑pressure readings via a smartphone slightly improved adherence compared with paper records but did not lead to significant BP reductions [5]. The app offers encrypted data storage and integration with Apple Health and Google Fit [6], making it a solid tool for tracking and analyzing measurements. The manufacturer states that each Omron blood‑pressure monitor is FDA‑cleared [7], making them reliable not just for occasional checks but for ongoing medical‑grade monitoring. Digital health can empower patients, but evidence matters. Always look for regulatory approvals, transparent privacy policies, and published studies. And remember: no app can replace regular follow‑ups with your doctor or adherence to prescribed treatment. #DigitalHealth #MobileHealth #HealthTech #MedicalDevices

𝐄𝐯𝐚𝐥𝐮𝐚𝐭𝐢𝐧𝐠 𝐇𝐞𝐚𝐥𝐭𝐡 𝐀𝐩𝐩𝐬: 𝐀 𝐏𝐫𝐚𝐜𝐭𝐢𝐜𝐚𝐥 𝐔𝐬𝐞𝐫 𝐂𝐡𝐞𝐜𝐤𝐥𝐢𝐬𝐭 Health apps promise a personal “doctor in your pocket” and the freedom to manage chronic conditions on your own terms - they can look like a hack for improving health, and sometimes that’s no exaggeration.  But there is a huge issue here - these apps actually influence our health - like drugs, like medical devices. Which means we should not use any flashy app like we would not eat any colourful pill. With roughly 337 000 options in the app stores, how to pick the ones that work? We’ve distilled the essentials into a checklist - not a validated framework, but a hint that can steer toward the real gems. The easiest way - is to check applications in specialised formulary, where validation is provided by certified bodies:  - ORCHA, NHS Apps Library, DiGA, Evernorth Digital Health Formulary etc. Or search for the following items on the web site of the provider: 1. Clinical validation - evidence that the intervention works: - Does the app provider share links to published studies in support of methods used by the app? Some trials (randomized controlled) are more trustworthy than others. 2. Regulatory status - confirms the app’s legal right to be on the market and its risk class: - CE-marked under MDR (Europe) - FDA-cleared or listed (US) - Listed in DiGA, NHS, or similar 3. Developer credibility - reduces “garage‑app” risk: - Backed by a real hospital, university, or medtech company - Medical experts or advisory board publicly listed - real people 4. Clinical relevance - keeps the assessment patient‑centred, not tech‑centred: - Is the health condition addressed clearly defined? - Does it follow particular clinical guidelines? Which? 5. Proven Outcomes:  - Data showing measurable improvement (e.g. symptoms, biomarkers) - Testimonials supported by metrics 6. Data protection & ethics:  - GDPR (EU) or HIPAA (US) compliant - Transparent data collection, storage, and sharing practices 7. Transparency: - Clear terms of use & privacy policy - Update history and version control are public Copypasting the list into ChatGPT will speed up the assessment This checklist was developed on the basis of advice issued by: https://lnkd.in/d9QwJakr  https://lnkd.in/dMktt7rV #HealthApps #DigitalHealth

𝐃𝐨𝐜𝐭𝐨𝐫 𝐏𝐚𝐮𝐥 𝐇𝐞𝐫𝐜𝐨𝐜𝐤: “𝟗𝟎% 𝐨𝐟 𝐦𝐞𝐝𝐭𝐞𝐜𝐡 𝐬𝐭𝐚𝐫𝐭𝐮𝐩𝐬 𝐧𝐞𝐯𝐞𝐫 𝐦𝐚𝐤𝐞 𝐢𝐭 𝐭𝐨 𝐦𝐚𝐫𝐤𝐞𝐭.” How does the absence of a go‑to‑market plan kill promising technologies? For every device that makes it to market, there are ten that “die” before launch. Even products that have passed certification and clinical trials often fail to find users and investors. According to Dr. Paul Hercock, a former physician and CEO of Mantra Systems, the problem isn’t the team’s intelligence or the quality of the solution, but the lack of a clear go‑to‑market strategy. Because intelligence isn't a strategy. Because a good device ≠ a good business. Because even elegant tools fail if they demand 5 seconds more from a nurse. In this candid interview, Dr. Hercock shares what kills promising devices: 👉 Neglecting policymakers - “They hold the purse strings.” 👉 Short-sighted funding cycles 👉 Misunderstood usability 👉 Tech alone will not change systems “People focus on the fix. But the real question is: are we solving the right problem in the right way?” Read the full conversation on why most innovations die quietly and how to beat the odds. https://lnkd.in/dAAyWxvD #HealthTech #MedTech #StartUps #ProductStrategy #DigitalHealth #Go2Market

𝐓𝐡𝐫𝐞𝐞 𝐇𝐚𝐧𝐝𝐲 𝐀𝐩𝐩𝐬 𝐟𝐨𝐫 𝐖𝐨𝐦𝐞𝐧’𝐬 𝐇𝐞𝐚𝐥𝐭𝐡 (𝐁𝐞𝐬𝐢𝐝𝐞𝐬 𝐅𝐥𝐨) Femtech is booming. According to FemTech Analytics, the sector is on track to reach $75.1 billion by 2025. Yet there’s also a “silent” potential worth $360 billion — an invisible market still untouched by today’s industry. Flo has long been a femtech synonym, but once you set aside that “obligatory first line,” you’ll find plenty of robust, evidence-based, and, crucially, battle-tested alternatives. Here are three apps we think deserve your attention. Natural Cycles° A fertility-monitoring app that in Aug 2018 cleared as a Class II “software application for contraception” by FDA. In effect, it offers a hormone-free alternative, using measurements of a woman’s physiological signals processed by a mathematical algorithm. More than 4 million women use it; it carries CE certification in the EU and its results appear in peer-reviewed journals. Ideal for anyone who wants to understand her cycle, avoid pregnancy, or, conversely, boost her chances of conceiving. Clue A Berlin-based project often compared with Flo, but built on a different philosophy. Clue tracks not only the cycle itself but 30-plus related parameters — from pain and mood to sleep and dreams. In 2021 the FDA cleared Clue Birth Control as a Class II software device for digital contraception, placing it among the few femtech platforms with that level of trust. Today Clue counts 10 million users in 190 countries. Ovia Health An entire ecosystem covering fertility tracking, pregnancy, and baby care. Ovia is popular with both individual users and corporate clients: many US-based employers weave the platform into their health-benefit programs. Since 2012, it has served more than 18 million users, and in 2021 it was acquired by healthcare giant Labcorp. This is a prime example of femtech’s integration into traditional healthcare. #Femtech #WomensHealth #DigitalHealth #HealthTech #HealthApps

𝐖𝐡𝐚𝐭 𝐀𝐩𝐩𝐬 𝐀𝐫𝐞 𝐀𝐯𝐚𝐢𝐥𝐚𝐛𝐥𝐞 𝐟𝐨𝐫 𝐂𝐨𝐮𝐠𝐡 𝐌𝐨𝐧𝐢𝐭𝐨𝐫𝐢𝐧𝐠 𝐚𝐧𝐝 𝐖𝐡𝐲 𝐓𝐡𝐞𝐲 𝐌𝐚𝐭𝐭𝐞𝐫 AI-driven analysis of cough and breath sounds is emerging as a distinct diagnostic modality. Early studies show clinically meaningful sensitivity and specificity for conditions such as tuberculosis, COVID‑19, and abnormal lung function. Whether acoustic AI can truly evolve into a low‑cost, scalable screening layer for respiratory care remains an open question. The first statistically solid signals suggest it may be more than just an intriguing concept. “Digital health and AI are redefining diagnostics. Voice and cough analysis can identify respiratory diseases earlier than traditional methods,” emphasizes Robin Farmanfarmaian, Co‑founder of i-GENTIC AI. Today this is no longer futurism: thanks to artificial intelligence, smartphones, and acoustic sensors, cough is becoming a digital biomarker - like pulse or blood oxygen levels. Here are some of the apps making this possible: Swaasa® - By Salcit Technologies - an app designed for diagnostics based on short recordings. A user coughs into a smartphone's microphone, and the algorithm assesses the likelihood of disease. Trained on a vast dataset of cough sounds, Swaasa is particularly useful in settings with limited access to healthcare. It can help detect COVID‑19, asthma, pneumonia, and other conditions in just a few seconds. Holds a Class B CDSCO medical device license (India) and ISO 13485 certification. 𝐂𝐨𝐮𝐠𝐡𝐏𝐫𝐨 - a wellness-class app for continuous cough monitoring developed by Hyfe. It works in the background, detects and classifies coughs, and builds individual patterns, tracking their frequency, intensity, and type. Users receive daily analytics and can monitor changes, for example, during recovery from a viral infection or in chronic conditions. The app is used in clinics and research projects, including studies on COVID‑19 and COPD. 𝐀𝐮𝐝𝐢𝐛𝐥𝐞𝐇𝐞𝐚𝐥𝐭𝐡 𝐀𝐈 created by RAIsonance Group. Not yet cleared for clinical use, but represents a Software-as-a-Medical-Device approach. This AI‑powered solution screens for respiratory diseases using the sound of a cough recorded through a smartphone app. The developers claim it is scalable, affordable, and designed to truly improve the management of respiratory diseases worldwide. All it takes is about 10 seconds of coughing into the app, and within 30 seconds, the user receives results, wherever they are. The technology is currently available for tuberculosis and COVID‑19 diagnostics, with solutions for pneumonia and influenza in final testing and 15 more conditions on the product roadmap. #DigitalHealth #HealthTech #MedTech #HealthcareInnovation #AIinHealthcare

𝐍𝐞𝐮𝐫𝐨𝐜𝐡𝐢𝐩𝐬: 𝐓𝐡𝐞 𝐒𝐭𝐚𝐭𝐞 𝐨𝐟 𝐁𝐫𝐚𝐢𝐧–𝐂𝐨𝐦𝐩𝐮𝐭𝐞𝐫 𝐈𝐧𝐭𝐞𝐫𝐟𝐚𝐜𝐞𝐬 𝐢𝐧 𝟐𝟎𝟐𝟓 The addressable healthcare market for BCIs (brain–computer interfaces) is huge. In the United States alone, an estimated 𝟓.𝟒 𝐦𝐢𝐥𝐥𝐢𝐨𝐧 𝐩𝐞𝐨𝐩𝐥𝐞 live with paralysis that limits their ability to use a computer or communicate. If even a fraction of them gain access to neural implants, the impact on their lives will be enormous. A BCI could let a completely locked-in person type messages, or allow someone with tetraplegia to steer a wheelchair using only their thoughts. Grand View Research values the 𝐠𝐥𝐨𝐛𝐚𝐥 𝐢𝐧𝐯𝐚𝐬𝐢𝐯𝐞-𝐁𝐂𝐈 𝐦𝐚𝐫𝐤𝐞𝐭 𝐚𝐭 𝐔𝐒 $𝟏𝟔𝟎.𝟒𝟒 𝐛𝐢𝐥𝐥𝐢𝐨𝐧 𝐢𝐧 𝟐𝟎𝟐𝟒, driven mainly by medical applications: paralysis, rehabilitation, and prosthetics. Commercial sales are virtually zero today (the devices are still in trials), yet the U.S. Government Accountability Office projects 𝟏𝟎–𝟏𝟕 % 𝐚𝐧𝐧𝐮𝐚𝐥 𝐠𝐫𝐨𝐰𝐭𝐡 𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝟐𝟎𝟑𝟎. That outlook explains the surge in investment: over the past five years, venture and corporate funding for neuro-tech start-ups has exploded. For example: Paradromics had raised 𝐔𝐒 $𝟏𝟎𝟓 𝐦𝐢𝐥𝐥𝐢𝐨𝐧 in venture capital and roughly 𝐔𝐒 $𝟏𝟖 𝐦𝐢𝐥𝐥𝐢𝐨𝐧 in NIH/DARPA grants as of February 2025. Outside healthcare, tech giants and other sectors are eyeing BCIs for broader uses - stoking market excitement even if widespread adoption is still some way off. Companies are investigating BCIs for: - hands-free control or fatigue monitoring - in the workplace - gaming and entertainment - even national-defense applications. Facebook (Meta) once ran internal BCI projects aimed at AR/VR interfaces (later pivoting to non-invasive techniques), while the defense agency DARPA has funded work on “telepathic” soldier-to-soldier communication. Many non-medical BCI concepts remain speculative or raise thorny ethical questionsб but the buzz around potential mass-market BCIs has attracted even more capital and talent, accelerating the field. The next 𝐭𝐰𝐨 𝐭𝐨 𝐭𝐡𝐫𝐞𝐞 𝐲𝐞𝐚𝐫𝐬 will be decisive. Early clinical data will either confirm expectations or cool the hype. If even one company secures FDA approval, the investment and adoption “floodgates” could open - much as the first approved gene therapy jump-started biotech. Global competition is also intensifying, leading to the next question: how are various regions faring in this neuro-tech race? Read the full text here: https://lnkd.in/drg6YRak

𝐒𝐞𝐪𝐮𝐨𝐢𝐚 𝐇𝐞𝐥𝐩𝐬 𝐌𝐞𝐧 𝐌𝐨𝐧𝐢𝐭𝐨𝐫 𝐚𝐧𝐝 𝐈𝐦𝐩𝐫𝐨𝐯𝐞 𝐓𝐡𝐞𝐢𝐫 𝐒𝐞𝐱𝐮𝐚𝐥 𝐇𝐞𝐚𝐥𝐭𝐡 Men’s sexual health remains one of the least represented and most taboo topics in digital medicine. Yet demand is there, while actual tools are few and far between. We spoke with Denis Galka, CEO of ‎Sequoia: Men’s Sexual Wellness, to learn more about the potential of apps for men’s health. According to its creators, Sequoia was developed in collaboration with medical experts, including sexologists, psychiatrists, and neurologists, and is based entirely on verified data and clinical protocols. At the core of the product lies a 21-day program designed to address issues identified via the International Index of Erectile Function (IIEF). Users complete the test, receive a personalized plan, and track their progress. The approach combines physical exercises, relaxation techniques, and meditation practices aimed at improving both erectile function and overall well-being. And there are already results to show for it. An internal study involving around 150 active users found that 79% reported improved health. Among them, 45% experienced enhanced erections and 26% reported increased libido. These findings were accepted for in-person presentation at the World Meeting on Sexual Medicine in Dubai — a clear sign of professional interest in the app. Despite this success, the app sometimes faces difficulty reaching parts of its target audience due to cultural barriers and unspoken taboos. “Men’s sexual health remains an ‘uncomfortable topic’ — both in Eastern Europe and many Western regions,” Denis explains. “The only difference lies in the level of sexual education and cultural openness. From Sequoia’s experience, the most persistent barriers exist in countries lacking a systemic approach to sex education. That’s precisely why the app was designed from the outset as an international solution: it contains no ‘national code’ but speaks in a language that is clear and relevant to men of various cultures and ages. This has led to the organic growth of interest in the product across the U.S., Europe, the CIS, and the Middle East.” Currently, Sequoia offers two modes: – a program for improving erectile function – a module for tracking overall well-being The team is also launching online consultations with medical professionals, including sexologists, psychotherapists, and other specialists. This will enable users not only to follow their action plan but also to quickly reach out to a physician when needed. This feature is especially valuable for expats, migrants, and digital nomads who often face challenges accessing basic healthcare in a new country — due to insurance, language barriers, or long waiting times. Additionally, a new AI-powered module is in development. It will analyze user data and generate health summaries for the day, week, or month, expanding the platform’s potential as a tool for preventive medicine. #DigitalHealth #HealthTech

𝐇𝐞𝐚𝐥𝐭𝐡-𝐓𝐞𝐜𝐡 𝐂𝐨𝐧𝐟𝐞𝐫𝐞𝐧𝐜𝐞𝐬 𝐢𝐧 𝐀𝐮𝐠𝐮𝐬𝐭 𝟐𝟎𝟐𝟓 𝐈𝐧𝐭𝐞𝐫𝐧𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐂𝐨𝐧𝐟𝐞𝐫𝐞𝐧𝐜𝐞 𝐨𝐧 𝐃𝐢𝐠𝐢𝐭𝐚𝐥 𝐇𝐞𝐚𝐥𝐭𝐡 & 𝐓𝐞𝐥𝐞𝐦𝐞𝐝𝐢𝐜𝐢𝐧𝐞 (𝐈𝐂𝐃𝐇𝐓) 𝐀𝐮𝐠 𝟑, 𝟐𝟎𝟐𝟓 │ 𝐆𝐥𝐚𝐬𝐠𝐨𝐰, 𝐔𝐊 + online Academics, health-IT engineers and clinical entrepreneurs meet for a fast-paced day of talks and demos on tele-consultation, m-health apps and data security 𝐑𝐞𝐠𝐢𝐬𝐭𝐫𝐚𝐭𝐢𝐨𝐧: $139 for online listeners to $329 for industrialists 𝐈𝐧𝐭𝐞𝐫𝐧𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐂𝐨𝐧𝐟𝐞𝐫𝐞𝐧𝐜𝐞 𝐨𝐧 𝐁𝐢𝐨𝐦𝐞𝐝𝐢𝐜𝐚𝐥 𝐒𝐜𝐢𝐞𝐧𝐜𝐞 & 𝐄𝐧𝐠𝐢𝐧𝐞𝐞𝐫𝐢𝐧𝐠 (𝐈𝐂𝐁𝐒𝐄) 𝟏𝟒 – 𝟏𝟓 𝐀𝐮𝐠, 𝟐𝟎𝟐𝟓 │ 𝐖𝐚𝐫𝐬𝐚𝐰, 𝐏𝐨𝐥𝐚𝐧𝐝 Academic-leaning forum on biomedical devices, signal processing, wearables, nano-medicine and other tech-heavy topics 𝐑𝐞𝐠𝐢𝐬𝐭𝐫𝐚𝐭𝐢𝐨𝐧: form € 250 for listener to € 450 for presenter 𝐈𝐧𝐭𝐞𝐫𝐧𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐂𝐨𝐧𝐟𝐞𝐫𝐞𝐧𝐜𝐞 𝐨𝐧 𝐇𝐞𝐚𝐥𝐭𝐡 & 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐈𝐧𝐟𝐨𝐫𝐦𝐚𝐭𝐢𝐜𝐬 (𝐈𝐂𝐇𝐌𝐈) 𝟏𝟒 – 𝟏𝟓 𝐀𝐮𝐠, 𝟐𝟎𝟐𝟓 │ 𝐕𝐞𝐧𝐢𝐜𝐞, 𝐈𝐭𝐚𝐥𝐲 Peer-reviewed forum on EHR interoperability, AI-driven clinical decision support, m-health security and other informatics hot spots. Good fit for clinicians, data scientists and med-IT vendors 𝐑𝐞𝐠𝐢𝐬𝐭𝐫𝐚𝐭𝐢𝐨𝐧: from ≈ US $350; student discounts available 𝟏𝟏ᵗʰ 𝐈𝐧𝐭𝐞𝐫𝐧𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐂𝐨𝐧𝐟𝐞𝐫𝐞𝐧𝐜𝐞 𝐨𝐧 𝐁𝐢𝐨𝐞𝐧𝐠𝐢𝐧𝐞𝐞𝐫𝐢𝐧𝐠 & 𝐁𝐢𝐨𝐬𝐜𝐢𝐞𝐧𝐜𝐞𝐬 𝟐𝟏 – 𝟐𝟑 𝐀𝐮𝐠 𝟐𝟎𝟐𝟓 │ 𝐏𝐚𝐫𝐢𝐬, 𝐅𝐫𝐚𝐧𝐜𝐞 A cross-disciplinary forum on regenerative medicine, biomaterials and next-gen diagnostics – ideal for startups looking at the biotech–medtech crossover 𝐎𝐫𝐠𝐚𝐧𝐢𝐳𝐞𝐫: International ASET Inc. 𝐑𝐞𝐠𝐢𝐬𝐭𝐫𝐚𝐭𝐢𝐨𝐧: From €350 for students online to €950 for non-students late registration 𝐁𝐢𝐨𝐭𝐞𝐜𝐡𝐠𝐚𝐭𝐞 𝐃𝐢𝐠𝐢𝐭𝐚𝐥 𝐏𝐚𝐫𝐭𝐧𝐞𝐫𝐢𝐧𝐠 𝟐𝟓 – 𝟐𝟗 𝐀𝐮𝐠 𝟐𝟎𝟐𝟓 │ 𝐎𝐧𝐥𝐢𝐧𝐞 (𝐡𝐨𝐬𝐭 𝐜𝐢𝐭𝐲 𝐋𝐨𝐧𝐝𝐨𝐧, 𝐔𝐊) Five days of one-to-one virtual partnering for biotech, medtech & digital-health deal-makers: 10 000+ meetings, workshops and “pop-up coffee” networking, all free for basic access. 𝐎𝐫𝐠𝐚𝐧𝐢𝐳𝐞𝐫: Biotechgate 𝐑𝐞𝐠𝐢𝐬𝐭𝐫𝐚𝐭𝐢𝐨𝐧: Basic pass free; premium upgrade - up to USD 598 Links to events in the comment #HealthConference #HealthTechConference #Conference #HealthTech

𝐀𝐈/𝐌𝐋-𝐄𝐧𝐚𝐛𝐥𝐞𝐝 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞𝐬: 𝐅𝐃𝐀 𝐮𝐩𝐝𝐚𝐭𝐞𝐝 𝐥𝐢𝐬𝐭 The FDA has just updated its list of AI/ML-enabled medical devices - the first update since September 2024. The list now includes 1,247 entries. Let’s take a closer look at what’s inside. 2016 marked the beginning of a consistent upward trajectory. From 2018 onward, the pace of approvals accelerated significantly. Peak years for newly listed devices: • 2023 — 226 devices • 2024 — 235 devices • 2025 (YTD) — 148 devices (on track to surpass previous years if the trend continues) Top Panels (Lead) by Number of Devices: Radiology – 956 devices Cardiovascular – 116 Neurology – 56 Anesthesiology – 22 Hematology – 19 Others (like Pathology, Ophthalmic, Dental, etc.) range from 1 to 16 devices each. Radiology completely dominates, reflecting the rapid adoption of AI in imaging diagnostics. Company Device Count Distribution: Siemens Medical Solutions USA, Inc. – 49 devices Followed by Canon (34), Aidoc (30), UIH (18), Philips (12) Long tail: ~400 companies have only 1 device each This long-tail distribution implies a vibrant and diverse innovation landscape, with both major players and many startups/specialists involved. Additional Insights & Conclusions: Explosive growth post-2018 coincides with: FDA’s 2019 discussion paper on the regulatory framework for AI/ML-based SaMD Maturity of deep learning in clinical domains, especially imaging Regulatory acceptance: The steady growth in clearances shows that the FDA has developed a tolerance and perhaps tacit support for AI/ML within the current 510(k) and De Novo pathways. Radiology dominance signals: Strong data availability - large imaging datasets High-volume, repeatable tasks suitable for AI assistance Discrepancy in panel names (e.g., "General and Plastic Surgery" vs "General & Plastic Surgery") suggests minor inconsistencies in FDA metadata standardization. #FDA #MedicalDevices 

𝗪𝗵𝗶𝗰𝗵 𝗳𝗼𝗿𝗰𝗲𝘀 𝘄𝗶𝗹𝗹 𝗴𝘂𝗶𝗱𝗲 𝘁𝗵𝗲 𝗱𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗼𝗳 𝗵𝗲𝗮𝗹𝘁𝗵𝘁𝗲𝗰𝗵 𝗶𝗻 𝘁𝗵𝗲 𝗻𝗲𝗮𝗿𝗲𝘀𝘁 𝟭𝟱 𝘆𝗲𝗮𝗿𝘀? A team of researchers from Politecnico di Milano, led by Cristiana Bolchini, explored this question using the STEEP framework - a tool widely used in foresight and strategic planning. STEEP stands for 𝗦𝗼𝗰𝗶𝗮𝗹, 𝗧𝗲𝗰𝗵𝗻𝗼𝗹𝗼𝗴𝗶𝗰𝗮𝗹, 𝗘𝗻𝘃𝗶𝗿𝗼𝗻𝗺𝗲𝗻𝘁𝗮𝗹, 𝗘𝗰𝗼𝗻𝗼𝗺𝗶𝗰, and 𝗣𝗼𝗹𝗶𝘁𝗶𝗰𝗮𝗹. These five domains are broad and stable enough to capture the long-term signals that influence our future, while being flexible across sectors like healthcare. Their foresight points to drivers that will define the evolution of health technologies by 2040: - ageing - mental health development - med(ai)cine - antimicrobial resistance,  - global climate changes  - environmental degradation - welfare and geopolitical competition  - tech giants’ pervasiveness  - data exploitation If you’re in healthcare, policy, tech, or research, this study is worth your radar.