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Sunset for SUNSET? Implementation Of Reg Review Policy Delayed To 2022 Pending Legal Battle

 
• By Elizabeth Orr

The US Department of Health and Human Services says trying to implement the rule while it is still being litigated could create confusion for the public, among other problems.

The sun sets over the ocean.
• Source: Shutterstock

A controversial proposal that would require the US Department of Health and Human Services to review tens of thousands of regulations over the next few years has been put on pause, at least for now.

The proposal, known as the Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) Rule, was initially set to go into...

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More from United States

US House Budget Sets FDA FY26 Funding At $3.2B

 
• By Sue Sutter and Derrick Gingery

A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.

Panel: FDA’s Home Healthcare Initiative Holds Promise, But Challenges Remain

 
• By Elizabeth Orr

During a recent FDLI panel, experts discussed the FDA's Home Healthcare initiative, highlighting its potential benefits and challenges. Key issues include usability testing, reimbursement, labeling for home use, and the need for innovation while ensuring patient safety.

J&J MedTech Launches KINCISE 2 Surgical Automated System In US

 
• By Natasha Barrow

The KINCISE 2 Surgical Automated System aims to “reduce the physical burden on surgeons compared to manual impaction in primary and revision hip and revision knee replacement procedures,” said J&J MedTech.

Guardant’s Multi-Cancer Detection Test Granted FDA Breakthrough Device Designation

 
• By Natasha Barrow

Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.

More from North America

‘Dawn Of FDA’s AI Era’ Has Arrived. Makary Announces Early Implentation Of ‘Elsa’ Platform

 
• By Brian Bossetta

US FDA Commissioner Marty Makary says the agency’s generative AI tool ‘Elsa’ will allow employees across the FDA to work more efficiently. The commissioner says Elsa’s launch comes ahead of schedule following a successful pilot program.

DeepLook AI Imaging Provides A Deeper Look At Dense Breast

 
• By Brian Bossetta

DeepLook Medical recently announced the commercial rollout of DL Precise, an AI-powered imaging platform that enhances breast cancer screening, at major healthcare institutions across the US.

First AI Breast Cancer Prediction Platform Receives FDA Authorization

 
• By Natasha Barrow

Clairity’s "first-in-class" mammography-based AI screening tool, Clairity Breast, provides "equitable risk assessments," expanding access to lifesaving early detection for breast cancer, said company founder Connie Lehman.