# Medical Devices Published articles for Medical Devices. This is one page of public article previews, not the complete archive. Follow Next page to continue. Summaries are not the original full articles. ## New AI technique could make minimally invasive surgeries safer and more precise DevFeed: [New AI technique could make minimally invasive surgeries safer and more precise]() Original publisher: [Read original article]() Author: Adam Zewe | MIT News Published: 2026-09-16T15:00:00Z Content type: news Language: en Sources: [MIT AI News]() Topics: [Artificial Intelligence](), [AI Research](), [3D](), [navigation]() Tags: [3d](), [ai](), [artificial-intelligence](), [computer-science-and-artificial-intelligence-laboratory-csail](), [computer-science-and-technology](), [computer-vision](), [electrical-engineering-and-computer-science-eecs](), [health-care](), [images](), [imaging](), [jameel-clinic](), [machine-learning](), [medical-devices](), [medical-imaging](), [minimally-invasive-surgery](), [mit-ibm-computing-research-lab](), [mit-schwarzman-college-of-computing](), [model](), [national-institutes-of-health-nih](), [navigation](), [paper](), [polina-golland](), [precision](), [real-time](), [research](), [school-of-engineering](), [vision](), [vivek-gopalakrishnan]() ### AI overview MIT researchers and collaborators developed xvr, an AI method that adapts to individual patients and rapidly aligns intraoperative X-rays with preoperative 3D medical scans. The technique is intended to improve surgical navigation for minimally invasive procedures. ### Source excerpt This patient-specific method, called xvr, helps doctors use X-rays for surgical navigation in fields such as orthopedics and neurosurgery. ## Lifesaving Lincoln Laboratory device wins 2026 Excellence in Technology Transfer Award DevFeed: [Lifesaving Lincoln Laboratory device wins 2026 Excellence in Technology Transfer Award]() Original publisher: [Read original article]() Author: Erin Lee | Lincoln Laboratory Published: 2026-09-11T13:45:00Z Content type: news Language: en Sources: [MIT AI News]() Topics: [Artificial Intelligence](), [Development](), [Software]() Tags: [2026](), [ai](), [ai-assisted-catheterization-device](), [ai-guide](), [artificial-intelligence](), [asha-rajagopal](), [autonomus-medical-technologies](), [awards-honors-and-fellowships](), [devices](), [emergency-medicine](), [engineering](), [excellence-in-technology-transfer-awards](), [federal-laboratory-consortium-for-technology-transfer](), [field](), [funding](), [health-sciences-and-technology](), [industry](), [invention](), [lincoln-laboratory](), [mass-general-hospital](), [medical-device-invention](), [medical-devices](), [medicine](), [mgh](), [military-medics](), [mit-intellectual-property](), [mit-lincoln-laboratory](), [mit-startups](), [mit-technology-licensing-office-tlo](), [national-institutes-of-health-nih](), [nih-funding](), [portable](), [prototype](), [real-world](), [research](), [samuel-kesner](), [startup](), [startups](), [technology](), [u-s-armed-forces](), [u-s-army]() ### AI overview AI-GUIDE, a portable catheterization device developed by MIT Lincoln Laboratory and Massachusetts General Hospital, received the Federal Laboratory Consortium's 2026 Excellence in Technology Transfer Award. The project is transferring its prototype to AutonomUS Medical Technologies for commercialization. ### Source excerpt The handheld catheterization device AI-GUIDE, created by Lincoln Laboratory and Massachusetts General Hospital, promises improved health outcomes for injured service members and civilians. ## Renesas RZ/G3L & RZ/G3SE - Ultra-low-power Cortex-A55 MPUs for industrial HMI and IoT applications DevFeed: [Renesas RZ/G3L & RZ/G3SE - Ultra-low-power Cortex-A55 MPUs for industrial HMI and IoT applications]() Original publisher: [Read original article]() Author: Debashis Das Published: 2026-09-11T13:41:08Z Content type: news Language: en Sources: [CNX Software - Embedded Systems News]() Topics: [Embedded Systems](), [Hardware](), [Arm](), [cpu](), [Internet of things]() Tags: [arm](), [cortex-a55](), [cpu](), [development-board](), [devices](), [display](), [embedded-systems](), [gateway](), [h-264](), [hardware](), [hmi](), [industrial](), [iot](), [linux](), [low-power](), [medical-devices](), [real-time](), [renesas](), [renesas-mcu](), [smarc](), [systems](), [zephyr](), [zephyr-os]() ### AI overview Renesas introduced the RZ/G3L and RZ/G3SE, two 64-bit MPUs for HMI and IoT edge systems. Both use Arm Cortex-A55 application cores and an Arm Cortex-M33 real-time coprocessor. The RZ/G3L adds a Mali-G31 GPU and H.264 codec for richer HMI applications, while the RZ/G3SE targets IoT devices with basic display needs. Both support low-power standby operation. ### Source excerpt Renesas has expanded its RZ/G Series with the RZ/G3L and RZ/G3SE, two new 64-bit MPUs for HMI and IoT edge systems. Both devices integrate up to four Arm Cortex-A55 application cores clocked at up to 1.2 GHz and a 200 MHz Arm Cortex-M33 real-time coprocessor. The two chips are pin-to-pin compatible but target different applications. The RZ/G3L integrates an Arm Mali-G31 3D GPU and H.264 video codec for HMI applications like retail terminals and medical devices. The RZ/G3SE removes the GPU and video codec and is designed for IoT devices with basic display requirements, including EV chargers and industrial gateway devices. Both can reduce standby power consumption to around 1 mW and resume operation quickly from deep standby, which is useful for devices that need to remain connected while consuming very little power. Renesas RZ/G3L and RZ/G3SE specifications: MPU core CPU Quad-core or Dual-core Arm Cortex-A55 @ up to 1.2 [...] The post Renesas RZ/G3L & RZ/G3SE - Ultra-low-power Cortex-A55 MPUs for industrial HMI and IoT applications appeared first on CNX Software - Embedded Systems News. ## Developing NVIDIA Holoscan Applications with CLI, Skills, and AI Coding Agents DevFeed: [Developing NVIDIA Holoscan Applications with CLI, Skills, and AI Coding Agents]() Original publisher: [Read original article]() Author: Elizabeth Goodman Published: 2026-08-19T22:22:37Z Content type: article Language: en Sources: [NVIDIA Developer](), [NVIDIA Technical Blog]() Topics: [Holoscan](), [AI-assisted coding](), [Command-line interface](), [Artificial Intelligence](), [real-time](), [Medical imaging](), [Robotics]() Tags: [agentic-ai-generative-ai](), [agents](), [ai-coding](), [clara](), [cli](), [computer-vision-video-analytics](), [edge](), [edge-computing](), [featured](), [healthcare-life-sciences](), [holoscan](), [medical-devices](), [medical-imaging](), [monai](), [nvidia](), [real-time](), [robotics](), [skills](), [video-analytics]() ### AI overview An NVIDIA Holoscan developer article about building real-time edge AI applications with CLI skills and AI coding agents, covering use cases including medical imaging and robotics. ### Source excerpt NVIDIA Holoscan is a platform for building real-time AI applications at the edge, from medical imaging to robotics. HoloHub is its companion repository: a... ## Engineering Audits for ISO 13485 Medical Device Software Quality Management Systems DevFeed: [Engineering Audits for ISO 13485 Medical Device Software Quality Management Systems]() Original publisher: [Read original article]() Author: Anna J McDougall Published: 2025-08-18T20:21:35Z Content type: article Language: en Sources: [Anna J McDougall]() Topics: [audit](), [Requirements](), [Development](), [Software](), [systems]() Tags: [audit](), [coding-style](), [compliance](), [engineering](), [engineering-management](), [iso](), [iso-13485-standard](), [lifecycle](), [management](), [medical-devices](), [processes](), [quality](), [regulatory](), [requirements](), [review](), [risk-management](), [safety](), [software](), [software-engineering](), [systems]() ### AI overview This case study explains what an engineering audit involves under ISO 13485 for medical device software. It covers Quality Management System documentation, lifecycle management, patient safety, risk management, regulatory requirements, and the author's experience updating engineering compliance documents. ### Source excerpt What is an Engineering Audit Like? An ISO 13485 Medical Device Engineering QMS Case StudyI think I found my new look. If there's one thing that gets me fired up, it's a good ol'-fashioned audit! ... Said nobody ever. Sadly, audits are a part of the business world that tend not to be fun. However, they also serve an important purpose, and are part of the transition from the "fun team lead" style of management into the "business leader" role is coming to grips with the unsexy stuff. As part of my role at HelloBetter, I was tasked with leading engineering compliance and reporting for ISO 13485, an internationally recognised standard for Quality Management Systems (QMS) specifically for medical device manufacturers, within the broader context of the EU Medical Device Regulation (MDR). For those who aren't familiar with what an audit of this kind involves, the simple version is this: Certain requirements exist as part of the standard, not just about how to effectively create and maintain software, but also how to document that compliance. This documentation is referred to as the Quality Management System (QMS), which as the name implies serves as documentation for how you maintain quality as per the ISO. The ISO isn't only about software, but software is part of "Lifecycle Management", tracking how a medical device (in this case) goes from design and development to distribution and surveillance. A company required to meet the ISO should therefore create and follow a system that ticks all the boxes for things like patient safety, risk management, and any additional regulatory hurdles. Typically once a year, an auditor is hired to enter the company and review the documentation alongside representatives from the company who guide them through the QMS. Additionally, individuals (like me!) are pulled from different parts of the company to talk through their processes and documentation, and to show any examples that may be relevant. My Experience with Engineering Compliance for ## FDA Releases Final Cybersecurity Guidance for Medical Devices DevFeed: [FDA Releases Final Cybersecurity Guidance for Medical Devices]() Original publisher: [Read original article]() Author: Adam Published: 2023-09-26T00:00:00Z Content type: opinion Language: en Sources: [Shostack & Friends Blog]() Topics: [Cybersecurity](), [Security](), [Architecture & Design](), [Security & Privacy]() Tags: [cybersecurity](), [medical-devices](), [product-security](), [sdl](), [security]() ### AI overview The FDA released final cybersecurity guidance for medical devices, replacing guidance that was nearly nine years old. The article says it is detailed and product-focused, and discusses its expected effects on medical device submissions, other regulatory guidance, and product liability litigation. ### Source excerpt The FDA has released their new guidance, which will be broadly impactful. ## Medical Device Threat Modeling Boot Camp DevFeed: [Medical Device Threat Modeling Boot Camp]() Original publisher: [Read original article]() Author: Adam Published: 2022-11-01T00:00:00Z Content type: news Language: en Sources: [Shostack & Friends Blog]() Topics: [Bootcamp]() Tags: [boot](), [community](), [medical-devices](), [other](), [partnership](), [training]() ### AI overview The article announces that two Medical Device Threat Modeling Bootcamps are returning. It says the programs are delivered in partnership with the Medical Device Innovation Consortium and provide intensive training, with the next session scheduled for December 12-16. ### Source excerpt Oh my gosh, the boot camps are back! ## Application Security Roundup - June DevFeed: [Application Security Roundup - June]() Original publisher: [Read original article]() Author: Adam Published: 2022-06-28T00:00:00Z Content type: opinion Language: en Sources: [Shostack & Friends Blog]() Topics: [Application Security](), [Requirements](), [risk-management](), [Cybersecurity]() Tags: [application-security](), [medical-devices](), [requirements](), [risk-management](), [security]() ### AI overview A June application security roundup highlights articles about requirements for medical-device cybersecurity, policy and implementation, and the importance of appropriate risk management and investigation despite concerns about cost and delay. ### Source excerpt Interesting appsec posts: from medical devices to bridges. ## FDA Draft Premarket Guidance DevFeed: [FDA Draft Premarket Guidance]() Original publisher: [Read original article]() Author: Adam Published: 2022-04-08T00:00:00Z Content type: news Language: en Sources: [Shostack & Friends Blog]() Topics: [Security](), [Cybersecurity]() Tags: [cybersecurity](), [healthcare](), [medical-devices](), [security]() ### AI overview The FDA has issued draft guidance on cybersecurity in medical devices, covering quality system considerations and the content of premarket submissions. Comments are due within 90 days. ### Source excerpt The FDA has issued draft guidance for pre-market security ## FDA Threat Modeling Playbook Now Available DevFeed: [FDA Threat Modeling Playbook Now Available]() Original publisher: [Read original article]() Author: Adam Published: 2021-11-30T00:00:00Z Content type: release Language: en Sources: [Shostack & Friends Blog]() Topics: [Security](), [Cybersecurity](), [Security & Privacy]() Tags: [cybersecurity](), [medical-devices](), [safety](), [security]() ### AI overview The FDA has released the Playbook for Threat Modeling Medical Devices, developed by MITRE and MDIC to increase threat-modeling knowledge across the medical device ecosystem and strengthen device cybersecurity and safety. ### Source excerpt How to threat model medical devices? The FDA has released a playbook! ## Medical Device Security Standards DevFeed: [Medical Device Security Standards]() Original publisher: [Read original article]() Author: Adam Published: 2019-11-02T00:00:00Z Content type: opinion Language: en Sources: [Shostack & Friends Blog]() Topics: [Security](), [Cybersecurity](), [standard]() Tags: [checksums](), [connectivity](), [cost](), [cybersecurity](), [digital-signature](), [disclosure](), [funding](), [medical-devices](), [network](), [pii](), [security](), [standards]() ### AI overview This commentary compares four cybersecurity approaches for medical devices: a comprehensive process-centered framework, MITA's factual material data sheet, disclosure of device behavior and cybersecurity properties, and funded threat-modeling work. It notes that differing national requirements can increase costs and create conflicting demands. ### Source excerpt Recently, I've seen four cybersecurity approaches for medical devices, and we can learn by juxtaposing them. ## PassMark received offer to not release rowhammer test DevFeed: [PassMark received offer to not release rowhammer test]() Original publisher: [Read original article]() Author: Mark Seaborn (noreply@blogger.com) Published: 2015-10-20T19:36:00Z Content type: opinion Language: en Sources: [Mark Seaborn]() Topics: [bug](), [Software](), [systems](), [Maintainers]() Tags: [banking](), [bug](), [devices](), [maintainers](), [medical-devices](), [memory](), [passmark](), [rowhammer]() ### AI overview The article reports that PassMark received an anonymous offer to suppress a rowhammer test for its MemTest86 tool in exchange for payment, but released the software anyway. It discusses the potential implications of rowhammer-related memory unreliability for systems including medical devices, banking systems, and flight control systems. ### Source excerpt Here's an interesting report of skulduggery related to the rowhammer bug. PassMark say they received an offer to not release a rowhammer test in their MemTest86 tool, in return for payment: "We had anonymous contact offering to act as a go between between us and unnamed memory companies, with a view to paying us not release the new version of MemTest86. Who knows how serious the offer was. Needless to say we didn't take up that option, and just released the software anyway. But the issue is a BIG issue. The lack of publicity up to now is somewhat surprising considering the implications. Many computers are fundamentally (slightly) unreliable in a random ways. Maybe this doesn't matter for home use, but for medical devices, banking systems, flight control systems, etc.. it is a big deal." The quoted post is from 20th February 2015 - after the rowhammer bug was publicised by the CMU paper but before we published about the exploitability of the bug. Some background: PassMark are the maintainers of MemTest86. (MemTest86 should not be confused with MemTest86+ which is an alternative, open source fork of the same original codebase.)