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At-Home Dialysis System Gets Landmark Medicare Designation

 
• By Brian Bossetta

Outset’s at-home dialysis system is the first technology approved for Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES), a designation created for US Medicare kidney patients.

Hand Holding Kidneys
• Source: Alamy

Outset Medical Inc. has received the first-ever approval from the US Centers for Medicare & Medicaid Services (CMS) for a Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES) for its Tablo Hemodialysis System to treat kidney disease.

The San Jose, CA-based medical technology company says the agency’s decision to grant Tablo TPNIES status will encourage health care...

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• By Natasha Barrow

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First At-Home Cervical Cancer Screening Tool Gets FDA Clearance

 
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New Treatment For Chronic Facial Pain Could Launch By Fall 2025

 
• By Elizabeth Orr

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More from Policy & Regulation

FDA Drops Package Labeling Guidance For Hernia Mesh Manufacturers

 
• By Brian Bossetta

The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.

Medtechs Wait For Dividend As UK Spending Review Prioritizes Healthcare And NHS

 
• By Ashley Yeo

Increased support for NHS services and delivery infrastructure announced in the 11 June government spending review by chancellor of the exchequer Rachel Reeves could boost inward investment and offer new market opportunities for medtechs.

UK Healthtech Center Of Excellence Given Key MHRA Digital Regulation Role

 
• By Ashley Yeo

Ahead of the 11 June UK spending review and its anticipated funding uplift for healthcare and life sciences, the MHRA announced an expansion of its digital expertise by creating a dedicated hub in Leeds, a renowned center of medtech excellence.