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The CMS is expanding the number of covered conditions under the program to include heart failure, COPD, substance use disorders and tobacco cessation.
Sylvain will work as chief operating officer of the diabetes technology company while continuing as its CFO.
The agency says the CMS and MA organizations aren’t doing enough to screen durable medical equipment providers, especially out-of-network companies that aren’t enrolled in Medicare.
Gaining authorization for transvaginal gynecologic procedures expands the list of indications for da Vinci SP in Europe.
By bringing its first patch pump to market, Beta Bionics will be able to compete with industry leader Insulet.
The separation will allow Medtronic to focus on its cardiovascular, neuroscience and surgical portfolios, CEO Geoff Martha said.
Reducing headcount at the Swiss site is part of an ongoing effort to simplify the company’s manufacturing footprint and supply chain.
FDA’s eSTAR framework raises the bar for documenting human factors and use-related risk.
David Bailey has rejoined STAAR after participating in the successful campaign to block Alcon’s takeover of the company.
The Centers for Medicare and Medicaid Services’ policy update extends Medicare coverage to severe aortic stenosis patients without symptoms, a change that analysts said will especially benefit Edwards Lifesciences.
Complaint volumes have outgrown manual triage, and medical device companies are turning to AI to keep up. The speed gains are real, but used carelessly the same tools can bury a reportable event at the bottom of a queue while the MDR clock runs. This piece maps where AI genuinely helps in post-market surveillance, where human judgment has to stay, and what validation, monitoring, and audit trails a defensible program needs. It is grounded in the current regulatory frame, including the QMSR and FDA's new inspection program (CP 7382.850) that took effect February 2, 2026, 21 CFR Part 803 reporting timelines, and ISO 13485 software validation expectations. It includes a practical table drawing the line between tasks that are safe to automate and decisions that must stay human-owned. The intended audience is quality, regulatory, and post-market surveillance professionals in the medical device industry. The post AI-Assisted Triage: Accelerating Post-Market Surveillance While Eliminating Reporting Blind Spots appeared first on MedTech Intelligence.
As healthcare shifts towards remote monitoring, connected devices and decentralized care, sensor technologies are becoming increasingly foundational to how medical devices collect, validate and transmit critical information. From remote patient monitoring and at-home care to connected medical devices and robotic-assisted surgery, sensing technologies can help enable earlier detection, more reliable clinical data and better-informed decision making. The post Sensors at the Edge: Powering Smarter Healthcare appeared first on MedTech Intelligence.
According to Deloitte, only 22% of life sciences leaders say they have successfully scaled AI, and just 9% report achieving significant returns. For materiovigilance, this highlights the growing gap between execution and team expectations. Within this gap, fragmented data and manual processes continue to slow response times and increase compliance risk, creating a disconnect between the promise of real-time safety monitoring and operational reality. How can organizations close this execution gap and evolve materiovigilance from a reactive compliance function into a proactive, data-driven discipline? The post Devices are Getting Smarter, Making Materiovigilance Evolve Faster appeared first on MedTech Intelligence.
GenAI-enabled medical devices hold transformative promise for patient care and the broader health ecosystem. At the same time, these devices may introduce unique risks when compared to traditional software and AI-enabled medical devices. The post FDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical Devices appeared first on MedTech Intelligence.
What 524B and QMSR actually require, in plain terms, including the post-market obligation that does not end at clearance? How both map to four kinds of exposure: cybersecurity, product liability, recall, and management liability. Where device makers are commonly unprepared against the new baseline, including the gap between cyber risk and product liability for software and devices. The post What 524B and QMSR Change About Medical Device Risk appeared first on MedTech Intelligence.
The increased digitalization of medical device manufacturing makes lean practices more applicable than ever. Keep these factors in mind to put them into action. The post Taking Lean Manufacturing to the Next Level appeared first on MedTech Intelligence.
A MedTech survey revealed that most sales teams are not using AI for strategic purposes, such as identifying opportunities, prioritizing accounts, or research. Instead, AI is mostly deployed to complete administrative tasks, such as drafting emails and summarizing meetings. Why is more needed? The post Why Few MedTech Sales Teams Are Using AI Where It Matters Most appeared first on MedTech Intelligence.
Emerging medical-device risks are often missed because early warning signs are fragmented across complaints, manufacturing, suppliers, returned products, clinical observations, and other data sources; not immediately as statistically significant trends. An engineering-centered, cross-functional approach connecting these weak signals to underlying mechanisms sooner, can improve designs, verification, manufacturing controls, and risk management before isolated issues become widespread quality problems. The post Why Organizations Miss Emerging Product Risk: Understanding the engineering mechanisms that remain hidden long before complaint trends become visible appeared first on MedTech Intelligence.
Catastrophic failures rarely stem from isolated hardware bugs. They breed where hardware, firmware, wireless telemetry, and clinical workflows intersect. These silent data integrity failures can invalidate entire research efforts without real-time detection, squeezing V&V Engineers between exploding complexity and compressed timelines. The post The Interface is the Risk: A MedTech Blueprint for AI and System Integration appeared first on MedTech Intelligence.
Medical device software development teams have always struggled with a deceptively simple question: How much of the system is actually complete? The post Beyond the Status Report: Using LLMs to Reveal the True State of SaMD Development appeared first on MedTech Intelligence.
Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, and a Trustee of the Bios Centre for bioethics welcomes the latest commitment to value-based procurement by NHS Supply Chain. Lord Hunt of Kings Heath, whose three-year campaign to see value-based procurement for medical devices introduced across the NHS [...] The post Campaigning Peer Secures Ministerial Commitment on NHS Supply Chain and Value-Based Procurement appeared first on Med-Tech Insights.
Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, and a Trustee of the Bios Centre for bioethics, reports industry reaction to new EU Med-Tech procurement regulations. The publication of the EU’s new procurement regulation has prompted a strong early reaction from MedTech Europe, which argues that the [...] The post MedTech Europe Calls for Procurement Reform Beyond Lowest‑Price Buying appeared first on Med-Tech Insights.
MethodSense has announced the launch of LuminLogic NextGen, a new AI-enabled quality and regulatory compliance platform that unifies eQMS, regulatory intelligence, submission readiness, and compliance management into one solution. At its core, is an advanced intelligence layer trained on 25+ years of MethodSense methodologies and decades of regulatory, quality, and product development expertise across the [...] The post MethodSense launches LuminLogic NextGen to transform MedTech compliance appeared first on Med-Tech Insights.
Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, and a Trustee of the Bios Centre for bioethics, highlights the latest developments in the regulation of AI for Med-Tech. The National Commission into the Regulation of AI in Healthcare has published a landmark set of recommendations designed to [...] The post Independent Commission Sets Out Blueprint for Safe, Faster AI Adoption in the NHS appeared first on Med-Tech Insights.
Proximie, the operating system for intelligent operating rooms, in collaboration with Amazon Web Services (AWS), Deloitte, and eight NHS hospitals, has announced the launch of the largest ever surgical AI evaluation undertaken in the NHS to treat more patients using the theatres and staff they already have – at scale. The year-long programme will see [...] The post Proximie launches largest ever surgical AI evaluation with AWS, Deloitte, and the NHS appeared first on Med-Tech Insights.
Ciliatech, a medical technology company developing surgical solutions for glaucoma, has announced FDA approval of the company’s Investigational Device Exemption (IDE) application to initiate a feasibility study in the US of the INTERCIL Uveal Spacer for glaucoma. The study is expected to enroll approximately 30 patients at three US clinical sites and will evaluate the safety [...] The post Ciliatech receives FDA IDE approval to initiate US feasibility study of INTERCIL appeared first on Med-Tech Insights.
Stratipath, an expert in AI-based precision diagnostics for breast cancer, and Aiforia, a pioneer in AI-driven diagnostics in pathology, has announced a strategic partnership. This collaboration aims to provide pathologists and oncologists with broader access to validated AI-powered diagnostic and prognostic tools and sets the stage for a long-term commercial relationship between the two companies. [...] The post Stratipath and Aiforia partner to expand access to AI-driven precision diagnostics in oncology appeared first on Med-Tech Insights.
Parasoft, a global leader in automated software testing solutions, is helping New Zealand-based medical technology company Kitea Health verify the safety-critical firmware behind the Kitea Sensor, a system designed to measure intracranial pressure. One of the most serious and common neurological conditions, hydrocephalus is caused by an abnormal buildup of cerebrospinal fluid in the brain [...] The post Parasoft and Kitea Health partner on safety-critical brain sensor firmware appeared first on Med-Tech Insights.
Prime Health has announced a £2 million investment in its Queen Anne Street centre, including the installation of a new Siemens Healthineers MAGNETOM Lumina 3T MRI system and the expansion of its preventative healthcare and personalised health assessment services. Located at 45 Queen Anne Street, in the heart of London’s Harley Street Health District, the [...] The post Prime Health announces £2M investment to install new MRI systems appeared first on Med-Tech Insights.
Intuitive, a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, has announced the CE mark approval of Force Feedback instruments for its da Vinci 5 surgical system, as well as a series of new system enhancements to be rolled out across Europe. Force Feedback technology is designed to enhance intra-operative [...] The post Intuitive introduces new enhancements for da Vinci 5 surgical system appeared first on Med-Tech Insights.
Improving AI Adoption Through Better Clinician Support jordan.scott_xWTB Tue, 09/15/2026 - 09:50 As health systems across the U.S. continue to explore how artificial intelligence fits into their operations, a frequent point of concern is whether or not a solution can be trusted in a clinical context. How will an AI-powered solution affect patient outcomes? How will it impact staffing and workflow? These are all valid questions that should be addressed at an organizational level even before the search for a solution is in the works. Not having clear answers before deployment can lead to difficulties scaling a project. A 2026 survey from clinical platform company Carta Healthcare found that 71% of healthcare organizations that are seeing the value in their AI projects are not scaling at pace due to several factors: 44% named integration with an electronic health records system as a top barrier; 37% named lack of executive sponsorship or budget; and 33% named competing organizational priorities. Clinical trust, ongoing cost and regulatory concerns all tied at 26% as a major barrier. Such impediments can and should be addressed when a health system has a robust AI governance structure with multidisciplinary participation that includes physicians and nurses from the start. In order to scale AI, organizations must have clear governance in place. Otherwise, projects never leave the piloting phase, user adoption never grows, and investments are squandered. Click the banner below to power employee productivity with AI. Jonathan Karl
AI Weapons Detection in Healthcare: Modernizing Hospital Physical Security jordan.scott_xWTB Thu, 09/10/2026 - 09:46 Workplace violence in healthcare facilities has become so prevalent that hospital workers in several states have gone on strike. Healthcare staff make up 10% of the U.S. workforce but experience 48% of nonfatal injuries from workplace violence. There’s room for improvement, because traditional hospital security measures may no longer be enough to address concerns about workplace violence. That’s why several healthcare IT and security leaders have started to deploy AI-powered weapons detection systems to protect providers and patients. Click the banner below to enhance your health system’s physical security program. Novid Parsi
AI Is Changing Cyberattacks. Are Healthcare Incident Response Plans Ready? teta.alim_beOd Thu, 09/03/2026 - 09:00 For years, healthcare IT teams have built their cybersecurity plans based on a stable assumption: Both the good guys and the bad guys work at human speed, have human capabilities and follow logical paths in their thinking. Artificial intelligence is changing all of that. On the attacker side, hackers are accelerating their lateral movement and privilege escalation with AI-controlled agents that bring truly novel attacks to the table. But on the defender side, security operation centers can use AI tools to correlate alert data, bubble up the most important issues and even react in milliseconds to an ongoing attack. That means a highly compressed timeline for both sides — speed that traditional incident response plans don't account for. Organizations need to protect patient data, maintain clinical operations and keep information flowing between care teams. This means reviewing incident response plans with a new awareness for the complexities of AI. Here are three items that may need to be added. Click on the banner below to learn more about how IT leaders are tackling newer cyber risks. Joel Snyder
FAIR for Hospitals: What a Ransomware Shutdown Really Costs jordan.scott_xWTB Wed, 09/02/2026 - 11:30 A ransomware shutdown in healthcare could cost $1.9 million per day on average, according to one 2024 report. The good news is that the average cost for healthcare providers to rebound from a ransomware incident dropped from $2.6 million in 2024 to just over $1 million in 2025, according to the “State of Ransomware in Healthcare 2025” report from Sophos. Still, given how serious ransomware threats are, health systems face challenges to build the right budget to protect against these attacks. Frameworks such as Factor Analysis of Information Risk (FAIR) provide a model for how to gauge the risk of ransomware attacks and what they will cost. In 2021, Jack Jones, then a CISO at Nationwide Insurance, established FAIR when the company needed to quantify risk for cybersecurity attacks. Today, Jones is the chairman of the FAIR Institute, which teaches organizations how to quantify the risk of attacks through the FAIR model and how to conduct a risk analysis. The methodology allows CISOs to learn how to communicate to their board like a chief revenue officer, says Bernadette Dunn, director of business operations and development at the FAIR Institute. It teaches that a company should allocate budget for cybersecurity if the probability of an attack is higher than an organization’s risk tolerance, Dunn says. “We communicate risk and the likelihood of a ransomware event happening, and if it happens, how much it’s going to cost the organization,” she explains. Dunn also notes the role of AI in ransomware attacks. “The bad folks are always attacking now, with AI especially, so we’re constantly trying to make sure we have the right controls in place,” Dunn says. “It’s this constant whack-a-mole scenario.” Click the banner below to read CDW's new 2026 Cybersecurity Research Report. Brian T. Horowitz
Training the Next Generation of Clinicians in the EHR jordan.scott_xWTB Mon, 08/31/2026 - 09:03 Medical students may be comfortable using digital tools, but that does not mean they are prepared for the electronic health record demands of residency. New clinicians must navigate the EHR to review extensive patient histories, manage orders and document decisions while keeping pace with clinical workflows. Meanwhile, artificial intelligence–powered ambient listening tools are transforming documentation from a writing task into one that requires clinicians to edit, verify and accept responsibility for AI-generated text. It’s important that medical students get early, hands-on training in the EHR to ensure clinical proficiency when they join the workforce. Click the banner below to learn how clinical workflow redesign drives healthcare optimization. Nathan Eddy
Should Your Health System Outsource the SOC? jordan.scott_xWTB Tue, 08/25/2026 - 13:04 The dark web and threat actors have been targeting the healthcare industry for years, but the threats are improving in accuracy, legitimacy and damage as artificial intelligence (AI) continues to evolve. Given these advances, the staffed IT department at a hospital may lack the training and 24/7 coverage needed to maintain a strong security operations center, or SOC. Without the manpower to constantly monitor the system’s devices and network against threats, healthcare leadership may consider outsourcing the role of a SOC to a trusted, third-party vendor. Click the banner below to read CDW's new 2026 Cybersecurity Research Report. Alexandra Shimalla
Reduce Clinician Burnout: The Case for Fewer Apps in Healthcare jordan.scott_xWTB Fri, 08/21/2026 - 11:08 In many health systems, a nurse must log in to multiple applications before seeing the first patient. A doctor may bounce between an electronic health record, imaging software, schedule tools and documentation systems during one patient visit. While each app promises better efficiency, too many disconnected technologies can have the opposite effect. Due to years of mergers, department-level purchasing and one-off point solutions, many health systems run hundreds if not thousands of applications. Nearly one-third of clinicians use four to 15 different applications on shared mobile devices per shift, according to an Imprivata survey. Meanwhile, hospitals rely on dozens of categories of clinical software, from EHRs and imaging systems to laboratory, pharmacy and scheduling platforms. “Every additional login, screen change and data transfer creates friction and cognitive load,” says Mirelva Drost, vice president of product management and marketing at Barco, a maker of medical displays, collaboration software and workflow tools used in radiology and operating rooms. “In fact, poorly integrated systems create additional complexity.” As health systems invest in artificial intelligence and digital transformation, workflow optimization will make all of this technology work together. Click the banner below to learn how clinical workflow redesign drives healthcare optimization. Donna Marbury
From a Clinician Perspective, Ambient AI Is Returning the ‘Joy Back to Medicine’ jordan.scott_xWTB Tue, 08/18/2026 - 09:44 As providers move beyond piloting artificial intelligence-powered clinical documentation tools to scaling deployments, they’re sharing best practices that can guide later adopters: using data to understand expected and unexpected outcomes, tailoring solutions for specific roles and specialties, and applying change management expertise to make new workflows sustainable. Two healthcare organizations in Pennsylvania and one based in North Carolina are highlighted here as they expand their use of ambient AI to reduce documentation time and improve patient interactions. Each has deployed AI scribes intentionally, with the view that deeper benefits — care transformed at the bedside and joy restored to clinicians — are the ultimate objectives. For all three providers, ongoing improvement is foundational to scaling successfully. “It’s definitely not yet a silver bullet, but I have a lot of data to suggest that we are heading in the right direction with this tool,” says Dr. Benjamin Slovis, chief medical information officer at Philadelphia-based Temple Health and an emergency medicine physician. That can hopefully assure patients that these emerging solutions are being adopted thoughtfully. “I applaud organizations for providing an environment where they can test as they slowly implement, giving opportunities for training, explaining to clinicians how to use the technology correctly and how to explain it to patients,” says Wendy Charles, a teaching assistant professor in health informatics, healthcare management and IT at the University of Denver. Click the banner below to learn more about the patient perspective on ambient listening. Amy Burroughs
From a Patient Perspective, Governance Is Crucial for Ambient Listening Tools jordan.scott_xWTB Mon, 08/17/2026 - 12:32 While healthcare providers have identified best practices for deploying ambient listening tools for clinicians, the industry has been slower to develop consensus around governance from a patient perspective. As a result, deployments are often inconsistent, and patients may have questions about privacy, security and data access. In March, a panel at the 2026 HIMSS Global Health Conference and Expo in Las Vegas called “Stakeholder Governance Strategies for Ambient Artificial Intelligence Scribes” set out to address that gap. Wendy Charles, teaching assistant professor in the health informatics, healthcare management and IT programs at the University of Denver; Jack Crumbly, management department chair at the Andrew F. Brimmer College of Business and Information Science at Tuskegee University; and Renée Pratt, assistant professor of information systems at the University of North Georgia, presented their findings. Their research colleagues include Deniz Coskun from MedDG, Tom Klein from Careeryze and Uma Challa from UCHealth. HealthTech interviewed Charles, Crumbly and Pratt together after the conference about issues that these artificial intelligence-powered tools may raise for patients and where governance can be improved. Click the banner below to learn more about the clinician perspective on ambient listening. Amy Burroughs
Workforce Augmentation Through AI: Closing the Talent Gap Without Adding Headcount jordan.scott_xWTB Tue, 08/04/2026 - 10:19 Healthcare organizations face a labor problem that recruitment alone cannot solve, with staff shortages extending beyond physicians and nurses to administrative and IT teams. A simultaneous demand for healthcare professionals — coupled with persistent and elevated levels of burnout — are placing ever more pressure on the remaining employees. Enter artificial intelligence: While the technology cannot manufacture scarce talent, it can increase the capacity of existing teams by taking on repetitive work, surfacing relevant information and helping employees make decisions faster. The objective is not to remove staff from care delivery but to redirect their time toward work that requires expertise, judgment and empathy. Click the banner below to learn how clinical workflow redesign drives healthcare optimization. Nathan Eddy
Survey of client health systems yields a 98.3 managed IT services score, underscoring partnership, experience and execution across EHR and ERP engagements. KANSAS CITY, KS. – September 15, 2026 – Healthcare IT Leaders, a national leader in IT consulting, managed services and workforce solutions, today announced findings from the Healthcare IT Leaders Complete Look 2026
Kyndryl completes acquisition of Healthcare IT Leaders, LLC The acquisition strengthens Kyndryl’s ability to help healthcare providers and payors modernize mission-critical technology environments by combining Healthcare IT Leaders’ healthcare consulting and application managed services expertise with Kyndryl’s infrastructure and AI capabilities. Read the full Press Release on Kyndryl.com This follows the original announcement on August
Cerner HealtheIntent was the name of a cloud-based population health and data platform. Current Oracle materials use Oracle Health Data Intelligence. The older HealtheIntent name remains familiar to many healthcare teams. The platform brings together clinical, claims, pharmacy, social, and other data. Teams can use that information to create longitudinal records and support analytics. It
Advanced scheduling helps healthcare organizations match staffing to expected demand, required skills, labor rules, employee availability, and operational priorities. A basic calendar or spreadsheet records the schedule. An advanced process uses workforce data and defined rules to help managers build it and respond when conditions change. In a hospital, a scheduling decision can affect labor
“Tell me about a time when...” If you have interviewed for a healthcare IT role, you have probably heard a question that starts this way. Employers ask behavioral questions because a real example shows how you think, what you did, and what happened next. The STAR method gives you a simple way to tell that
Healthcare moves quickly, and few people can read every report or attend every conference. A good podcast can make important ideas easier to follow. It also gives experienced leaders time to explain their thinking. The best show for you depends on what you want to learn. Some focus on executive leadership and organizational change. Others
Epic Cheers is Epic's customer relationship management application for healthcare. Health systems can use it to coordinate outreach and support contact-center conversations. It can also connect people with care and measure outcomes after an interaction. Cheers works within the broader Epic ecosystem, but it is only one part of a healthcare CRM program. The organization
Epic Radiant is Epic's radiology information system (RIS). It connects imaging orders, scheduling, protocoling, patient preparation, exam tracking, documentation, results, charging, and reporting. Radiant commonly works with picture archiving and communication systems (PACS), imaging devices, voice-recognition or reporting tools, and other clinical systems. The exact workflow depends on an organization's licensed capabilities, imaging specialties, facilities,
Epic Cupid is Epic's cardiovascular information system (CVIS). It connects cardiology orders, scheduling, procedure documentation, structured reporting, results, communication, charging, and analytics. Epic's current specialty-product overview says Cupid supports invasive and noninvasive cardiology procedures. It is designed to work with PACS, ECG, imaging, and other connected systems. Exact capabilities depend on the licensed products, configuration,
An Epic EHR conversion reaches nearly every part of a health system. It affects clinical care, revenue cycle, patient access, data, interfaces, devices, training, and support. A complete build does not mean the organization is ready. Leaders still need timely decisions, validated workflows, usable history, prepared users, and a practical transition plan. The eight pitfalls
