Radically different
The FDA Center for Devices and Radiological Health (CDRH) is warning manufacturers of drug-device combination products of the potential for nitrosamine impurities, which are classified as probable carcinogens associated with forms of cancer. The FDA did not name specific devices or kinds of devices that could be at risk in the letter it sent to…
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Stryker has disclosed lower compensation for its top executives and median employee in a recent filing with the U.S. Securities and Exchange Commission. Median employee pay dropped for the second consecutive year, while executive compensation decreased due to lower cash performance bonuses and option awards. Stryker was the world’s fifth-largest medical device company in our…
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Washington state hospitals say their Medicare patients are waiting two to four times longer in some cases for procedures that are now subject to prior authorization under a new Medicare program.
The report from Sen. Maria Cantwell (D-Wash.) is among the first to document alleged patient harm stemming from the Centers for Medicare and Medicaid Services’ new Wasteful and Inappropriate Service Reduction, or WISeR, Model. Cantwell is one of several Democratic members of Congress who have been urging CMS to scrap the program, which launched Jan. 1.
Cantwell aired her concerns about WISeR to Health and Human Services Secretary Robert F. Kennedy Jr. at a Senate Committee on Finance hearing Wednesday. She said CMS is using artificial intelligence as a “denial device” and that patients are waiting weeks to get sign off for services that previously didn’t require approval.
Background: Quality of life (QoL) is an important surgical outcome, commonly assessed through self-reports, and has the potential to be enhanced by objective information from personal technologies such as smartphone apps and wearables. Understanding patients’ perspectives on this application of personal technologies is scarce. Objective: This study aimed to identify operational aspects of smartphone- and wearable-based assessments, as well as human and operational factors that may influence the acceptability of already owned (mostly smartphone) or new (mostly wearable) technologies by patients for pre- and post-surgery QoL assessments. Methods: Through purposive sampling, 41 patients from 3 health care centers in Switzerland, the United States, and the United Kingdom, who were undergoing or scheduled for surgery for degenerative cervical myelopathy (DCM), liver transplantation, or total hip replacement, were interviewed about their perceptions of QoL, current use of smartphones, health apps, and wearables for self-management and their views on using these technologies to assess QoL before and after surgery. Results: Across the 3 studies (n=41), most (n=36) patients reported improved QoL after surgery, mainly due to reduced pain and fatigue and regained autonomy, while a few patients with DCM reported no change (n=2) or worsening (n=1). Patients were generally comfortable using smartphones and tablets, but few (n=4) used them for health management. Wearables were perceived differently across groups: they were well accepted in transplant@US, moderately in hip@UK, and least in myelopathy@CH. Many patients with DCM found wearables “useless,” believing they added little to their self-awareness or recovery and could not replace human clinical judgment. Others expressed concerns about privacy, complexity, notifications, and battery life, while some acknowledged their motivational value when the data were clearly interpreted. Despite varying acceptance levels, most participants said they would consider using such devices if they contributed to research or improved care. Conclusions: Given a mostly negative attitude of patients toward wearables, we discuss the use of smartphone-based automated logging of physical functioning (sleep and physical activity) instead. Such logging may be less accurate than a dedicated wearable, but it may be accurate enough to measure their pre- and post-surgery physical functioning changes. Additionally, a smartphone has the advantage of being already well integrated into the daily life of patients from the perspective of its functionality and the patients’ routines, contrary to wearable devices, which would have been provided to the patients in the context of pre- and post-surgery clinical care and require additional attention for their continuous wear, charging, and data synchronization, among others.
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Compremium’s noninvasive Quantis CVP (central venous pressure) measurement device joined the FDA’s Total Product Life Cycle Advisory Program (TAP) after earning Breakthrough Device designation in January 2026. The FDA designed TAP to “help spur more rapid development of high-quality, safe, effective, and innovative medical devices that are critical to public health” and expedite patient access…
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Henry Schein reported pay increases for three of its five executives in 2025, while median employee pay increased from the year before. The Melville, New York-based medical product supplier is the 11th-largest medical device company in the world, according to Medical Design & Outsourcing’s 2025 Medtech Big 100 ranking by revenue. Since then, Henry Schein increased…
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NEWS RELEASE: Freudenberg Medical launches CleanAssure, an ISO class 5 controlled cleanroom for sterile single-use assemblies New controlled cleaning and sterilization service supports biopharma customers with ready-to-use single-use assemblies Kaiserslautern, Germany — Freudenberg Medical, a global contract design and manufacturing partner to the medical device and biopharma industry, announced the launch of CleanAssure, a new ISO…
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At Paragon 28, now part of Zimmer Biomet, engineers asked if there was a better implant shape to support foot and ankle anatomy. It took three novel instruments and a novel implant to make it a reality. When Paragon 28 Director of Engineering Ken Roggow and his team approached the drawing board to design a…
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