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Alere Challenges Medicare Billing Block

 
• By Elizabeth Orr

The company, which had its Medicare supplier billing number revoked in November, filed an appeal with an administrative law judge. Alere also asked the US District Court for the District of Columbia to force CMS to allow its Arriva unit to stay in the competitive bidding program while the ALJ appeal is pending.

Alere Inc. unit Arriva Medical LLC is fighting the US Centers for Medicare & Medicaid’s decision to ban Arriva from billing Medicare over fraud allegations.

The company appealed its suspension to a CMS administrative law judge (ALJ), who should hear the case within 30 days...

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More from Diabetic Care

Dexcom Builds Momentum Ahead of 15-Day G7 Launch, Eyes AI and G8 for Growth

 
• By Shubham Singh

Dexcom introduced a new AI-powered smart food logging feature in its Stelo and G7 platforms. This tool allows users to generate detailed meal descriptions from photos and analyzes the glycemic impact of those meals.

Injuries And Deaths Linked To Baxter Infusion Pump

 
• By Brian Bossetta

The US FDA says Baxter has notified customers about an issue with its Novum IQ Syringe Pump that is linked to two deaths and multiple injuries.

Medtronic’s MiniMed Expands EU Uses Of MiniMed 780G And Readies For US Expansion Amid Competition

 
• By Shubham Singh

The timing aligns with Medtronic’s plan to spin off its $2.8bn diabetes unit, now named MiniMed. As a standalone entity, MiniMed will be more responsive to competition, regulatory shifts, and the diabetes technology needs of healthcare systems.

Abbott Lowers Outlook But Headwinds Are Temporary

 
• By Natasha Barrow

Despite headwinds, executives remain optimistic about growth in Abbott’s medical devices and diabetes divisions and plan several product rollouts, including the Volt PFA catheter for electrophysiology and the dual glucose-ketone sensor CGM.

More from Device Area

HistoSonics Sells Majority Stake To Investor Syndicate In Deal Valued At $2.25Bn

 
• By Marion Webb

HistoSonics’ CEO Michael Blue describes the deal as a win-win for all stakeholders and plans to use the money to expand clinical indications, as well as the global reach, for its Edison system.

PathAI Talks PCCPs: ‘Accelerated Software Updates, Saves Time And Money’

 
• By Natasha Barrow

The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.

SpotitEarly Sets Up US HQ, Launches Trials For Dog- And AI-Powered Early Cancer Detection Test

 
• By Marion Webb

Among early cancer screening tests, SpotitEarly stands out by combining dogs’ superior sense of smell with machine learning. SpotitEarly plans two US clinical trials for breast and lung cancer aiming to seek FDA clearance, but needs more funding to support clinical development and commercialization.