CMS Establishes New Office to Lead Health Technology and Product Strategy
The Office of Health Technology and Products will oversee digital modernization, data exchange, and artificial intelligence initiatives across federal health programs.
Category: Standards
Standards
Latest
Standards
Latest
Advanced Global Health Starts with Safe Medical Device Repairs
A HIMSS Foundation executive argues that expanding right-to-repair policies to healthcare could create patient safety and cybersecurity risks tied to medical device repair.
Standards
Latest
FDA Issues Safety Guidelines for Charging Medical Devices to Prevent Overheating
The agency recommendations emphasize using manufacturer-authorized accessories and avoiding overnight charging to reduce fire and injury risks.
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Hospitals Reject More Medical Devices Over Cybersecurity, Index Finds
New research finds 24% of healthcare organizations report cyberattacks affecting medical devices, with 80% impacting patient care, as cybersecurity becomes a core requirement in medical device purchasing.
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Report Flags Healthcare as High-Risk for Cyberattacks, With Human Error a Leading Factor in Breaches Overall
A new report identifies healthcare as a top-risk sector for data breaches and ransomware, with human error involved in most breaches.
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Olympus Receives FDA Clearance for Open Surgery Sealing Device
The new Powerseal Open Extended Jaw device is the fourth addition to the company’s advanced bipolar surgical energy portfolio.
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FDA Clears Abbott’s AI-Powered Coronary Imaging Software
The Ultreon 3.0 software uses optical coherence tomography and artificial intelligence to guide physicians during procedures to open blocked arteries.
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FDA Clears Avatar Medical Vision for 3D Imaging and Surgical Planning
The software supports CT and MR image visualization across standard displays, glasses-free 3D systems, and virtual reality environments.
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Nearly Half of Healthcare Organizations Hit by Network Cyberattacks
New research finds a gap in network security deployment as federal regulators move to tighten requirements for clinical environments.
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MITRE Report Outlines Cybersecurity Risks for Medical Devices Using AI and Cloud
The analysis identifies emerging threats to patient safety and device performance as manufacturers adopt new technologies and advanced encryption.
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More Than 2,200 US Healthcare Centers Hit by Data Breaches Since 2023
With California leading the nation in incidents and 52 new investigations already launched in 2026, cybersecurity experts urge organizations to address critical network vulnerabilities.
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FDA Issues Alert for Aligned Medical Solutions Angiographic Syringe Kits
The recall involves convenience kits containing syringes that may disconnect during use, posing risks of blood loss and air embolism.
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CMS and FDA Launch RAPID Pathway to Speed Access to Breakthrough Medical Devices
The new pathway aims to cut red tape and bring predictability to Medicare coverage for Breakthrough devices.
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Philips Receives FDA Clearance for Rembra CT Platform
Clearances for Rembra CT, Rembra RT, and Areta RT aim to enable high-throughput imaging at scale and elevate precision across the cancer care pathway.
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