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Conference Mania
The first quarter of 2025 was a whirlwind of conferences, starting with the Consumer Electronics Show in Las Vegas in early January.
During the major tech show, Medtech Insight accompanied Deloitte analysts Neal Batra and Andrew Davis into the buzzling digital health exhibit hall at the Venetian to highlight rising trends, innovative companies and solutions that are poised to transform the health care of tomorrow.
While AI continued to dominate much of the conversation, Davis noted that this was probably the first year where organizations provided insights on top of data. Novel AI solutions offered real-time analysis and feedback, such as providing the risk of diseases and early disease detection to help people manage their health.
Among the ongoing key trends in the wearable space is miniaturization. MindMics showcased earbuds that monitor heart health by capturing every heartbeat from inside the ear. NextSense launched consumer smart earbuds to help improve sleep quality and optimize brain health. The company’s product, Tone Buds, monitor brain activity during sleep and provides pink noise stimulation during deep sleep to promote restoration, NextSense said.
Batra and Davis also see more “hyper-segmentation” in which companies develop products catering to specific groups such as women’s health, employer-based solutions, and the elderly.
At HIMSS 2025, held 3-6 March and also in Las Vegas, Medtech Insight sat down with Aneesh Chopra, chief strategy officer at health care data platform Arcadia, to discuss topics including how the federal approach to health data has evolved since his tenure as the first US chief technology officer under the Obama administration.
As a member of the National AI Advisory Committee, Chopra advises the current administration on, in his own words, “making sure we can do more than we can to ensure America thrives in the age of AI.”
He told Medtech Insight he is excited about DOGE, saying that the underlying idea that President Trump would direct a team to bring the best and brightest technologists, data scientists and engineers together to make the government more effective and efficient is “kind of as mom and apple pie as you’re going to get.”
True interoperability in health care is only a few years away, he says. Right now, Arcadia is assembling comprehensive patient health records using information gathered from value-based care contracts. Chopra noted that the ability to generate such a record for every patient “may be at an arm’s-length reach of employers and government-sponsored plans.”
At LSI 2025, held 17-21 March in Dana Point, CA, Medtech Insight spoke with Gary Guthart CEO of robotics giant Intuitive Surgical, about the company’s expected full launch of the da Vinci 5, the new Force Feedback technology and planned digital advancements including a digital coach. Guthart also discussed planned additional clearances for the ION robotic platform to help pulmonologists do more than biopsy of suspicious lung nodules. He also provided views on the future of robotic-assisted procedures and the need for scientific rigor in validation.
Digital Alert System Saves Time – And Potentially Lives
The FDA recently cleared a patient monitoring system developed by Danish physicians that sends vital signs data directly to clinical staff, allowing them to keep tabs on patients without having to be in the room.
Eske Aasvang, a professor and anesthesiologist at Rigshospitalet, a teaching hospital in Copenhagen, Denmark, and his colleague Christian Meyhoff, a fellow professor and anesthesiologist at Copenhagen’s Bispebjerg and Frederiksberg Hospital, collaborated with the Technological University of Denmark to develop WARD-CSS — (the wireless assessment of circulatory and respiratory distress-clinical support system) — which monitors patients around-the clock and alerts front-line personnel about dangerous deviations in vital signs.
The two also founded the company WARD 24/7.
The point of the system, as Aasvang explained to Medtech Insight, is to address surgical complications that often occur outside of ICUs when patients are returned to the general ward and are no longer being watched 24/7.
Wireless sensors are attached to patients to collect and integrate data — such as blood pressure, heart rate, respiration rate, and oxygen levels. That data, along with an overview of the patient’s condition, then goes to an app which nurses can access on their smartphones showing deviations in patients that might warrant immediate attention.
The system’s AI algorithm interprets the data so nurses receive only alerts showing severe distress, not normal changes.
Another major benefit of the system is that it allows nurses to monitor patients without having to be in the room, which not only can address staffing shortages but can mitigate burnout.
FDA Warning Letter For AI-Based Musculoskeletal Screening Tool
Denver-based Exer Labs Inc. has received a warning letter from the US FDA because, the agency says, the company’s marketing for its Exer Scan exceeded what is allowed under the device’s 510(k) clearance.
The scan uses AI to assess patient images and evaluate musculoskeletal conditions, such as problems with gait. It has been FDA-cleared as measuring exercise equipment, a classification for devices intended to facilitate or provide exercise rehabilitation. However, during an October 2024 inspection the agency found that the company’s website said Exer Scan could screen and treat patients with Parkinson’s, tuberculosis, cerebral palsy and other serious conditions. The webpage also recommended the scan’s use to automate operative or conservative treatment pathways for orthopedic care and to screen and treat Medicare and Medicaid patients in assisted living as a fall-prevention measure.
However, the device has not been authorized to treat or diagnose any of these conditions. Exer Labs would need to get a PMA to market the scanner for uses that go beyond the 510(k) clearance, the agency said.
Most of the language quoted in the letter was no longer visible on the site as of late March.
In addition to the problems with Exer Labs’ marketing, the FDA also noted concerns about the company’s compliance with quality system regulations. In particular, the agency said, the company did not have proper systems established for design control, complaint handling, purchasing controls or Corrective and Preventive Actions (CAPA), among others.
The agency noted that a follow-up inspection will be required to ensure Exer Labs has made the required changes.
Webinar: Focus On Security In ‘Cyber Device’ Submissions
Almost all devices integrating digital health features need to comply with the FDA’s “cyber device” regulations, two former FDA reviewers said during a recent webinar hosted by the Archimedes Center for Healthcare and Device Security at Northeastern University and UC San Francisco.
Medcrypt CEO Naomi Schwartz and Archimedes Center director Kevin Fu explained that 2023 legislation defined a “cyber device” as a device that has software; can connect to the internet; and are vulnerable to cybersecurity threats. All three characteristics are present in most devices that use digital technologies, even those that aren’t meant to connect to the internet.
One key element of cyber device compliance is developing a plan to manage cybersecurity vulnerabilities that allows the device developer to address signals from multiple sources, including user complaints as well as problems identified by government researchers. These measures should consider older software and software that users don’t directly interact with. Additionally, the company should have a process for disclosing vulnerabilities to the public.
Schwartz also said that the FDA expects cyber devices to be secure, which means correcting vulnerabilities in what the agency considers a “reasonable” timeline. This is shorter for something that could endanger patients than for something that is simply an inconvenience, she noted.
Finally, developers of cyber devices need to provide a software bill of materials alongside any submissions. These should note any potential software vulnerabilities because, Fu and Schwartz said, regulators may view it as a red flag if a submission claims the product has no issues at all.
Despite current major changes at the FDA under new health secretary Robert F. Kennedy Jr., the speakers did not expect cyber device regulation to change significantly. Historically it’s been a bipartisan priority, they noted.
In this week’s Digital Health Roundup, MedTech Insight’s Shubham Singh explores how Roche’s unveiling of its next-generation sequencing (NGS) prototype challenges Illumina. The SBX technology is set to compete directly with Illumina’s NovaSeq and NextSeq platforms.
Roche Unveils NGS Prototype Challenging Illumina’s Market Dominance
Roche has officially introduced its next-generation sequencing prototype, which will be available in two formats – a modular open-source platform and a fully integrated Roche Diagnostics product– will see a full commercial launch in 2026. Roche’s announcement has already begun influencing market dynamics, particularly affecting Illumina, the current leader in NGS technology. Analysts believe that laboratories may delay purchasing new Illumina systems in anticipation of Roche’s offering, potentially leading to reduced capital expenditures in 2025.
While Roche’s sequencing-by-expansion (SBX) technology is still a year away from full launch, the announcement alone has raised concerns for Illumina. Analysts speculate that labs might postpone purchases, waiting to assess Roche’s system before making investment decisions. Additionally, Roche’s aggressive pricing strategy could place further pressure on Illumina, forcing it to lower prices and impacting its margins. The competition is also expected to extend beyond Illumina, with Pacific Biosciences (PacBio) and Oxford Nanopore likely to face increased rivalry.
Roche has designed its SBX system to cater to both short-read and long-read sequencing customers, positioning it as a direct competitor to Illumina’s NovaSeq and NextSeq platforms. A key advantage of SBX is its ability to complete full-genome sequencing in just seven hours, offering a combination of speed and cost-effectiveness.
According to Roche Diagnostics CEO Matthew Sause, SBX technology leverages a Complementary Metal Oxide Semiconductor (CMOS)-based sensor module, allowing for high flexibility and scalability. This enables researchers to conduct sequencing efficiently, regardless of workload size, without waiting to accumulate large sample batches.
The company has been working on early pilot transfers at its Penzberg facility to ensure scalability. Pricing remains another area of uncertainty, with Roche stating that the system will be competitively priced but declining to provide specifics.
