AdvaMed Urges CMS to Revise Proposed DME Competitive Bidding Rule
The medtech association cites risks to patient safety, reduced competition, and potential cost increases if the rule is implemented as is.
Category: Standards
Standards
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Standards
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FDA Flags Defibrillator Lead Issue Linked to Serious Injuries, Deaths
Boston Scientific’s Endotak Reliance leads with ePTFE-coated coils may reduce shock efficacy due to coil calcification.
BD Recalls Certain Alaris Pump Infusion Sets Over Accuracy Issues
Use with select infusion sets may lead to over- or under-infusion, bolus inaccuracies, and alarm delays, BD warns in recall notice.
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Senate NDAA Includes Right-to-Repair Provision for Military Equipment
Advocacy groups urge the House to adopt similar language in its version of the bill.
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Lake Havasu City Physical Therapist Dies in Hyperbaric Chamber Fire
Walter Foxcroft III was killed in a flash fire inside a hyperbaric chamber, according to the Lake Havasu City Fire Department. Foxcroft was the founder of Havasu Health and Hyperbarics, where the incident occurred.
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Disconnection Hazard Prompts Recall of AirLife Infant Ventilation Circuits
AirLife and manufacturer Vyaire are recalling certain infant heated wire circuits due to the risk that accessory adapters provided with the product may unintentionally disconnect during setup or use when the circuit reaches operating temperature.
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Bipartisan Bill Would Expand Military’s Right to Repair Equipment
The newly introduced legislation would require all military branches to include right to repair provisions in contracts, aiming to cut costs and improve readiness.
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HL7 Launches AI Office to Develop Standards for Artificial Intelligence in Healthcare
New initiative aims to create global standards for transparent, interoperable, and safe AI in clinical and operational settings.
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AMMA, AdvaMed Back Key Measures in ‘One Big Beautiful Bill’
The bill, signed into law on July 4, includes tax, trade, and investment provisions that industry groups say will support domestic manufacturing and medtech innovation.
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Medical Device Cyberattacks Hit 22% of Healthcare Orgs, Disrupting Patient Care in Majority of Cases
A new report shows that security concerns shift from IT systems to operational technology.
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Joint Commission Teams with CHAI to Set National AI Guidance
The Joint Commission and the Coalition for Health AI will co-develop guidance and certification to support AI integration across US healthcare organizations.
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New Report Flags Gaps in Right to Repair Compliance
Nearly half of reviewed products lacked accessible repair manuals, and 44% had no spare parts available, according to a new report from US PIRG.
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FDA Grants Breakthrough Status to SonoClear for Intracranial Ultrasound
Designed to reduce imaging artifacts during neurosurgery, the SonoClear System now has FDA Breakthrough Device status and is moving toward 510(k) submission.
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On the Front Lines of a New Era in Disaster Response
With disasters on the rise, HTM teams are relying on modern tools and coordinated planning to support smarter emergency response.
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