CMS Should Create New Roadmap For Breakthrough Technologies, Trade Group Urges

The Medical Device Manufacturers Association wants the US Medicare agency to come up with a new rule for implementing a coverage pathway for breakthrough devices by June 2022.

ARROW POINTING ON HIGHWAY
• Source: Alamy

With the Medicare Coverage for Innovative Technologies (MCIT) rule on the block, industry is trying to stop the ax from falling.

More from Approvals

First At-Home Test For Multiple STIs Gets FDA Clearance

 
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The Visby Medical Women’s Sexual Health Test is the first over-the-counter test cleared by the US Food and Drug Administration to detect chlamydia, gonorrhea and trichomoniasis. It delivers results in about 30 minutes.

Quibim Extends Into US Market With FDA Authorization Of QP-Prostate CAD

 

The US FDA's clearance of QP-Prostate CAD positions the company to support US health care providers and growing markets for fusion biopsy and focal therapy, said Quibim CEO and founder Angel Alberich-Bayarri.

Dexcom Eyes US FDA Clearance For 15-Day CGM, But Insurance Coverage Remains Uncertain

 
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Tempering expectations on the immediate market impact for the upgraded continuous glucose monitor, Dexcom notes insurance coverage and pump integrations will take time to finalize.

Sebela’s Miudella Is First Hormone-Free IUD To Win FDA Approval In 40 Years

 
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The device, which uses a flexible frame to ease insertion and minimize the dose of copper, is 99% effective in preventing pregnancy. Clinical trial lead David Turok said it represents “a real advance” in contraceptive options.

More from Policy & Regulation

Swiss Blast US Import Tariffs As Medtechs Look For Dialog To Forestall Damage To Industry

 
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Swiss medtech exporters seek urgent diplomatic action from the Swiss Federal Council in a bid to overturn the 2 April US decision to put tariffs on goods imports.

Democrats Condemn Trump’s HHS Layoffs During House Hearing On OTC Drug User Fees

 

Energy and Commerce Health Subcommittee Democrats focus on criticizing HHS Secretary Kennedy’s RIF announcement, including 3,500 FDA jobs among cuts across HHS agencies. Representatives were left wondering if user fee programs would continue, even if reauthorized.

Regulatory Experts Alarmed By Credible April Fool’s About US Targeting EU Notified Bodies

 

A seemingly humorous social media post on April Fool’s Day struck a nerve with regulatory experts, reflecting real concerns about recent actions by the US Food and Drug Administration.