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Cadence, a company that makes AI-enabled software to support hypertension management, will join the pilot, which allows companies to collect real-world data through Medicare.
See how Dell and NVIDIA are bringing AI-powered solutions to every point of care.
Buying tissue-healing company AMS will bring H.B. Fuller into the markets for formulated biosurgicals and mechanical closures.
CHAI plans to create playbooks to help organizations defend against — and leverage — these powerful systems.
An outside party gained access to some company systems, but the medical device maker found no evidence that sensitive or protected data was obtained and said its operations are running normally.
European private equity firm Astorg will run the business as an independent diagnostics company, led by former PerkinElmer CEO Dirk Bontridder.
BD called completing enrollment in the study “a significant milestone in its advanced tissue regeneration strategy and expansion efforts.”
The diabetes tech firm recently brought its sales and marketing teams in-house after taking over commercialization of its device from Ascensia Diabetes Care.
Bill Shields, who led transcatheter mitral and tricuspid therapies at Medtronic, has joined Versa Vascular, developer of a valve repair treatment.
The multiyear partnership will connect Abbott’s over-the-counter Lingo sensor and the Google Health app.
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.
Zimmer Biomet will hire 500 professionals over the next three years for its new Bengaluru technology centre, expanding its AI, software engineering, and R&D capabilities as India strengthens its position as a global healthcare innovation hub. The post Zimmer Biomet to Hire 500 in India as New Bengaluru Technology Centre Drives AI and MedTech Innovation appeared first on MedTech Intelligence.
AdaptHealth is investigating a material cyberattack after attackers used a social engineering scheme to compromise a third-party contractor's account, stealing patient data from its cloud-based systems as reports link the breach to the ShinyHunters extortion group, though the attribution remains unconfirmed. The post AdaptHealth Investigates Data Breach After Social Engineering Attack, Possible Link to ShinyHunters Emerges appeared first on MedTech Intelligence.
MTI Viewpoints Insights shared by industry relative to healthcare and the advancement of medical technology. Jaimon Jose, senior director of engineering and compliance at CharmHealth, is a software architect and technical leader with more than 18 years of product development experience in the areas of identity and security technologies, distributed systems, cloud security, and data… Continue reading → The post Applying Agentic AI to Healthcare Delivery: The Key to True Transformation appeared first on MedTech Intelligence.
Post-market surveillance (PMS) systems in the medical device industry have become increasingly sophisticated in collecting complaints, monitoring adverse events, and generating regulatory reports. However, many organizations still struggle to translate these insights into timely clinical action and meaningful patient safety improvements. This article examines the growing disconnect between regulatory reporting and operational decision-making, explores the challenges of signal detection and prioritization, and outlines practical strategies for building closed-loop PMS systems that improve patient safety outcomes and organizational responsiveness. The post From Compliance to Clinical Action: Fixing the Broken Loop in Post-Market Surveillance appeared first on MedTech Intelligence.
Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, who played a key role in securing the government’s commitment to introducing Value Based Procurement (VBP) across the NHS in England, sets out some of the key steps to its delivery. When the Department of Health and Social Care [...] The post Value Based Procurement: The Origin Story appeared first on Med-Tech Insights.
Claret Capital Partners, one of Europe’s largest independent growth debt fund managers has made an investment through its funds, of €30m in Carvolix, formerly Affluent Medical. Carvolix is a French commercial- and clinical-stage medical technology company specialising in the international development and industrialisation of AI-driven mini-robots and biomimetic implants to revolutionise interventional cardiology and the treatment [...] The post Carvolix receives €30m to accelerate commercialisation of MedTech portfolio appeared first on Med-Tech Insights.
Dr Sarah Rudebeck, a senior NHS clinical psychologist, has won a £75,000 Innovate UK Women in Innovation Award to build an AI learning tool for pupils with special educational needs and disabilities (SEND). She is one of 61 award winners, selected from a record 1,590 applications. According to the team, Recallify Classroom will help young [...] The post NHS Psychologist wins £75k Innovate UK award to build AI tool for SEND pupils appeared first on Med-Tech Insights.
Following World Lung Cancer Day, RevealDx, a leader in AI characterisation of lung nodules, has announced a distribution agreement and strategic investment of $3.4 million by 4DMedical, expanding access to its flagship product, RevealAI-Lung. RevealAI-Lung has received MDR Certification, TGA Approval, and FDA clearance. In the transaction with 4DMedical, Chestnut Partners, Inc. served as the exclusive financial advisor to RevealDx. This news follows 4DMedical’s [...] The post RevealDx announces distribution agreement and investment from 4DMedical appeared first on Med-Tech Insights.
Mahesh Wale, UK&I Business Unit Head for Retail, Consumer Goods, Travel, Hospitality, and Life Science at Cognizant explores how the growing focus on AI regulation is changing the way MedTech companies approach innovation For several years, AI has been viewed as one of the biggest opportunities for the MedTech sector. With research finding that 91% [...] The post Making AI work in a regulated MedTech industry appeared first on Med-Tech Insights.
BlueWind Medical, Ltd., a leader in Implantable Tibial Neuromodulation (ITNM) and developer of the Revi System, a patient-centric solution for urgency urinary incontinence (UUI), has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Revi Extend. The company says it is planning a limited U.S. launch of Revi Extend in the [...] The post BlueWind Medical receives FDA clearance for Revi Extend implant appeared first on Med-Tech Insights.
Paragonix Technologies, a leader in organ transplant technologies, organ offer, and surgical recovery services, has announced the successful completion of two landmark kidney transplants utilising the KidneyVault Portable Renal Perfusion System. Originating from the same donor at The Queen’s Medical Center in Honolulu, Hawaii, both kidneys were transported thousands of miles in commercial aircraft cargo [...] The post Landmark kidney transplants set benchmark for long-distance organ transport appeared first on Med-Tech Insights.
Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, looks at the new government appointee designated Minister for Health Innovation. A recently appointed Minister at the Department of Health and Social Care, James Frith MP, has announced on social media that he is designated as Minister for Health [...] The post James Frith MP to lead on MedTech for Government appeared first on Med-Tech Insights.
Women’s health has historically faced significant gaps in research, diagnosis, and access to personalised care. However, advances in digital health, artificial intelligence, and at-home diagnostics are creating new opportunities for women to better understand their bodies, monitor changes over time, and engage more proactively with healthcare professionals. In this interview, Vivoo explores how technology is [...] The post How at-home testing is putting personalised insights into women’s hands appeared first on Med-Tech Insights.
Penumbra, Inc has announced the results of THUNDER, an Investigational Device Exemption (IDE) study, to evaluate the safety and effectiveness of THUNDERBOLT, the company’s novel computer assisted vacuum thrombectomy (CAVT) system, in stroke patients with emergent large vessel occlusion (ELVO). The data were presented during a late-breaking session at the Society of NeuroInterventional Surgery (SNIS) 23rd Annual Meeting, July 20-24, 2026. “Mechanical thrombectomy is considered frontline treatment for stroke; however, current technologies may not fatigue and completely ingest [...] The post THUNDER study demonstrates Penumbra’s Thunderbolt CAVT system is safe and effective for stroke care appeared first on Med-Tech Insights.
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 discover the road to an effective and secure enterprise AI strategy. 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 lean how clinical workflow redesign drives healthcare optimization. Nathan Eddy
Healthcare Data Governance Is the Foundation of Modern Medical Research jordan.scott_xWTB Mon, 08/03/2026 - 14:22 With support from artificial intelligence, the possibilities for research advancements are endless. AI tools can review and process information, find patterns and make predictions faster than humans can, with the potential to expand our understanding of complex conditions and accelerate the development of lifesaving therapies. However, just like any other software, AI is only as reliable as the data sets it pulls from. A solid data governance framework — referring to the standards and policies that dictate how data is collected, organized, stored and shared — provides the infrastructure necessary to make medical breakthroughs possible. “Data is fundamental to advanced analytical technology,” says David Ebert, chief AI and data science officer at the University of Arizona. “Good data governance allows you to implement AI and use it for research in a responsible way that gets trustable results.” EXPLORE: How does minimum viable data governance enable smarter healthcare? Core Components of a Healthcare Data Governance Framework To make meaningful progress in healthcare research, a strong data governance framework will include: Clear data ownership, or defining which team is responsible for oversight of a particular data set’s accuracy and security Strong privacy controls, including encryption Shareability policies that balance innovation with compliance Quality management processes including continuous monitoring to catch biases and mistakes early Standardized definitions so that different teams can communicate effectively A data catalog to help researchers easily locate and utilize data Metadata management, which helps AI tools interpret data accurately Data lifecycle management policies Amy Trainor, system vice president and CIO at Ochsner Health and a registered nurse, emphasizes that good data management must be embedded in the organization’s culture. Every team member, whether involved in patient care, medical education or administration, has a role in both safeguarding data and ensuring its accuracy. “Governance cannot sit off to the side as a policy binder. It has to show up in how data is defined, accessed, protected, measured and used every day,” Trainor says. “When data is incomplete, inconsistent or poorly defined, it introduces risk to the integrity of the research.” Click the banner below to find the right strategy to turn data into insights. Erin Laviola
When a Device Fails, Care Doesn’t Stop: Enabling Remote Recovery in Clinical Environments jordan.scott_xWTB Mon, 08/03/2026 - 12:34 An endpoint failure inside a hospital or clinic can quickly become a patient care problem. When a clinician cannot reach an electronic health record or complete documentation, the disruption can affect every subsequent part of the care journey. Endpoint recovery is therefore a critical part of clinical care resilience, and not merely an IT help desk function. Intel vPro® provides out-of-band access when an operating system won’t load, while Intel Core Ultra Series 3 processors add fleet intelligence intended to identify potential hardware problems earlier. DISCOVER: Intel helps IT teams standardize, deploy and manage laptops and mobile workstations. Nathan Eddy
Understanding the Digital Health Divide’s Role in Healthcare Access jordan.scott_xWTB Tue, 07/28/2026 - 14:30 As quickly expanding digital healthcare technologies promise to improve access and outcomes, many people face the risk of being left out. Underserved populations, including geographically remote, economically disadvantaged or digitally under-resourced people, are experiencing a digital health divide — an inequality in the ability to access, use and benefit from healthcare technologies. For instance, patients in rural communities without reliable broadband often cannot access telehealth services. As a result, they miss work and travel hours to see their doctors, or they simply don’t go. DISCOVER: Strengthen your hospital’s foundation for care anywhere. “When these barriers exist, people delay care,” says Michael Archuleta, CIO at Mt. San Rafael Hospital in Trinidad, Colo. “Patients often don’t seek treatment until they’re sick enough to require an emergency visit.” But healthcare technology can help close the digital health gap. IT leaders are working to deploy sophisticated technologies while ensuring deployment doesn’t inadvertently deepen existing disparities in access and outcomes. “Our responsibility as healthcare leaders is making sure innovation reaches every patient,” Archuleta says. “Technology should be the great equalizer.” The Digital Health Divide by the Numbers Income, location and age, otherwise known as social determinants of health, all play a role in digital access — and, in effect, the digital health divide. Americans with the lowest household incomes are much less likely than higher-income Americans to have broadband internet at home: 54% of households earning less than $30,000 a year, compared with 94% of those making over $100,000, according to the Pew Research Center. And rural Americans are notably less likely than suburbanites to subscribe to home broadband (71% versus 84%). While lower-income Americans are more likely to rely on their smartphones for internet (34% of low earners, compared with just 4% of high-earners), adults 65 and older are the least likely age group to own a smartphone (78%), compared with almost all adults under 50 (97%). “The digital divide is about much more than internet access,” Archuleta says. “It’s really about opportunity.” Click the banner below to sign up for HealthTech’s weekly newsletter. Novid Parsi
Q&A: Lessons Learned From Nutanix’s Healthcare Cloud Report jordan.scott_xWTB Wed, 07/22/2026 - 09:00 As healthcare organizations recognize the need to improve operational efficiency, ease clinical workflows, and enhance patient care and experience, they are increasingly turning to artificial intelligence. However, many organizations don’t have the proper infrastructure to support AI initiatives. The 8th Annual Nutanix Healthcare Vertical Enterprise Cloud Index dives into healthcare’s current interest and preparedness related to AI. The report points out challenges including infrastructure readiness and shadow AI, plus other trends around containerization. HealthTech spoke with Scott Ragsdale, vice president of sales for healthcare and SLED at Nutanix, about his biggest takeaways from the report and how healthcare organizations can navigate this space going forward. READ MORE: Build a hybrid cloud and data center strategy that sustains care. HEALTHTECH: What were some of the biggest findings from the report and what do they mean for healthcare organizations? RAGSDALE: The biggest takeaway for me is that healthcare organizations are embracing AI at a fast pace, but their infrastructure isn’t evolving to keep up with it. It’s well known that healthcare has a lot of technical debt. Overcoming that to take on these new AI workloads is the biggest challenge for organizations. Eighty-eight percent of healthcare leaders told us their current infrastructure isn’t fully ready to support AI deployment, and it’s evident. Jordan Scott
Fact or Fiction: Sifting Through Common Misconceptions About Cyber Resilience jordan.scott_xWTB Wed, 07/15/2026 - 09:21 At a high level, cyber resilience is the ability to anticipate, withstand, recover from and adapt to adverse conditions, stresses, attacks or compromises affecting systems and processes that rely on digital resources. When resilience is lacking, the consequences of an event can compound. A data breach may lead to legal and financial impacts, while a systems outage in healthcare could jeopardize patient care. Let’s sift through some common misconceptions about cyber resilience and determine what kernels of truth can ground better strategy. Click the banner below to find out why AI resiliency is the next phase of cyber resilience. CDW Staff
How NIH Is Translating 70 Years of Health Data To Speak the Same Language jordan.scott_xWTB Fri, 07/10/2026 - 10:25 The National Institutes of Health sits on one of the largest collections of biomedical research data in the world. Decades of federally funded studies on health issues such as heart disease, lung conditions, sleep disorders and genomics have generated petabytes of information. But for most of that history, the data was collected by different institutes and under varying standards. Historically, those disparate formats haven’t been easy to integrate. That dissonance is a problem when the goal is to train artificial intelligence models that can accelerate medical research. Three NIH offices — the National Heart, Lung, and Blood Institute (NHLBI), the National Library of Medicine (NLM) and the Office of Data Science Strategy (ODSS) — are now working together to fix it. In an AFCEA Bethesda Health IT Summit panel on operationalizing data at scale in federal health, leaders from the three offices described the interoperability infrastructure they’re building and why it matters for AI. Click the banner below to find out how to take advantage of data and AI for better healthcare outcomes. Ashley Hackett
Healthcare Interoperability Improves Care and Patient Experiences jordan.scott_xWTB Wed, 07/01/2026 - 14:29 Imagine someone suffering an injury while on vacation. They receive treatment at the nearest emergency department, where they are instructed to follow up with their primary care physician at home. But if the home physician isn’t able to access information about the care their patient received, the physician has to rely on the patient’s own recall. The doctor might order unnecessary tests the patient has already had, wasting time and money. With healthcare interoperability, however, healthcare team members have all of their patients’ medical information at their fingertips. Click the banner below to find out how the smart care continuum improves clinical outcomes. Novid Parsi
The Path Forward to Advancing Care for Dementia Patients jordan.scott_xWTB Mon, 06/29/2026 - 10:36 As rising case rates collide with mounting caregiver shortages and increasing pressure on long-term care systems, dementia care continues to grow as a healthcare specialty. Universities and research groups are exploring how artificial intelligence, robotics and assistive technologies could help detect cognitive decline earlier, support caregivers, improve patient safety and allow more older adults to remain in their homes longer. Current efforts range from AI-powered diagnostic models and assistive-intelligence systems to socially assistive robots, some being tested in real home environments. Click the banner to learn how tech eases operational challenges and improves resident experiences. Nathan Eddy
August 10, 2026 Today we begin a new chapter in our company’s history. For 15 years, we’ve worked with health systems and healthcare companies to design an organization they can turn to for expertise at every stage of their clinical and business systems journeys. We listened. We learned. And we built a strong reputation as trusted partner. Today, our teams are the “humans in the loop” supporting some of the nation’s largest digital healthcare
If your health system has been live on Epic for several years, you've probably had some version of this conversation. The CFO asks what the organization is getting from its Epic investment. The CMIO says clinicians are drowning in documentation. The IT director says the build queue is underwater. Everyone agrees something should change. Nobody can say, with evidence, what to fix first. Most tenured Epic
Oracle Health Patient Accounting (OHPAC), also known as RevElate, is a major advancement in healthcare revenue cycle technology. Rather than forcing organizations to choose between a standalone patient accounting platform and a clinically integrated revenue cycle, OHPAC combines the strengths of both approaches. Dedicated patient accounting solutions, like OHPAC, allow for greater flexibility, scalability, and
The small town where I grew up had about 750 people and a county hospital. The hospital is gone now. The nearest emergency room sits more than 30 minutes away on a two-lane road. Since 2010, more than 200 rural facilities have closed or ended inpatient care. Mine was one of them. That experience is
There's a version of healthcare IT consulting that looks straightforward from the outside. A health system has a technology problem. A consulting firm has the expertise. Work gets done. The reality is considerably more complicated, and the gap between those two descriptions is where most consulting engagements either succeed or fall apart. I've spent my
A System Health Check is a structured, independent assessment of your live healthcare IT enterprise systems (EHR, ERP, WFM) and the business operations it is meant to support. Conducted by experienced consultants, it evaluates your current configuration, how the system is actually being used, and where gaps between system capability and operational reality are creating
I never imagined my most powerful lesson in healthcare IT would come from a hospital bed. During my high-risk pregnancy, I watched firsthand what it means when clinical technology works the way it should and understood what is at stake when it doesn’t. My son Jake was born at just four pounds but went home
In Part One, we shared the story behind our brand refresh and the belief that has guided Healthcare IT Leaders for 15 years: that healthcare only works with the right humans in the loop. In this second installment, we go deeper exploring the four service pillars that define how we show up for health systems,
Healthcare IT has never been short on complexity. New platforms. Mergers. Regulatory mandates. The relentless pressure to do more with tighter margins and thinner teams. And through all of it, one truth has held constant since we founded Healthcare IT Leaders in 2011: Healthcare only works with humans in the loop. It’s the reason we
Having the right players in the right seats and knowing where to extend your bench is critical in any UKG Pro Workforce Management implementation. After working alongside health systems through every phase of UKG Pro Workforce Management from initial scoping through post-go-live optimization, patterns emerge. The implementations that go well are well planned and resourced.
