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Proposed Medicare Code Change Could Affect Reimbursements On Glaucoma Devices

 
• By Brian Bossetta

A proposed change to US Medicare billing that would go into effect 1 January might give one manufacturer an edge over its competitor.

EYE CHART.
• Source: Alamy

Many glaucoma patients who have cataract surgery to reduce intraocular pressure (IOP) often receive a stent – a tiny device implanted in the eye’s drainage channel to help restore the natural flow of fluid.

Two of the top devices used in this procedure are the iStent from Glaukos Corporation and the Hydrus from...

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Warning Letters - July 2025

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Brazil’s Medtechs Look To Solutions After 50% US Tariff Hit Amid ‘Scenario Of Uncertainty’

 
• By Bernard Murphy

Hopes that last-minute negotiations might exempt Brazil’s $300m medtech exports from the latest round of US tariffs have been dashed, leaving the industry braced for further market instability that countermeasures could trigger.

Survey Reveals Gaps In Medtech Compliance Processes

 
• By Elizabeth Orr

Medical device firms often have serious compliance gaps, a recent Veeva MedTech survey found. Only 50% of the companies surveyed are confident in their global registration data, with 70% reporting inconsistencies during audits. The report recommends automation and better data governance.

Environmental Group Questions FDA’s Stance On PFAS In Medical Devices

 
• By Brian Bossetta

The US FDA says PFAS used in medical devices are safe and that there’s no reason to restrict them in device production. An environmental group finds the agency’s assertion questionable.

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Environmental Group Questions FDA’s Stance On PFAS In Medical Devices

 
• By Brian Bossetta

The US FDA says PFAS used in medical devices are safe and that there’s no reason to restrict them in device production. An environmental group finds the agency’s assertion questionable.

EU4Health Boost For Orphan Devices And SMEs

 
• By Ashley Yeo

EU4Health, the main funding instrument for EU health initiatives, has put renewed emphasis on orphan devices in its 2025 work program, published in July.

Roche Eyes 2026 FDA Nod After CE Mark For pTau181 Test To Boost Global Alzheimer’s Diagnosis

 
• By Shubham Singh

The Elecsys pTau181 test, which requires only a blood sample, provides a less invasive alternative to cerebral spinal fluid procedures. A negative result could rule out Alzheimer’s and help patients avoid further testing with CSF or PET scans.