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News We’re Watching: MedRhythms App Gets FDA Clearance, Recalls For Megadyne And Draeger, Elixir Stent Trial Moves Ahead

 
• By Marion Webb, Reed Miller, and Brian Bossetta

This week, companies including MedRhythms, Allergan and Urotronic announced FDA clearances; Quest and Envision launched a prostate cancer test; and the FDA designated two recalls as class I.

"News We're Watching" Feature Image
• Source: Medtech Insight

MedRhythms, Inc. announced on 15 July that it has received US Food and Drug Administration clearance for MR-001, marketed as InTandem, a digital therapeutic to treat walking deficits in chronic stroke patients.

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More from Regulation

‘The FDA Will Be Looking For Avenues To Regulate Laboratory Developed Tests’

 
• By Natasha Barrow

The FDA's final LDT ruling was struck down in federal court last month. For now, diagnostic companies can commercialize under CLIA regulations or apply for FDA approval. McDermott and Tribun Health have shared insights on the risks, pros and cons of both regulatory routes.

Update: Italy’s IMQ And Belgium’s SGS Named 15th and 16th IVDR Notified Bodies

 
• By Amanda Maxwell

Ireland’s NSAI reinstated under IVD Regulation designation list

Trump’s Preliminary 2026 HHS Budget Plan Protects US FDA User Fee Collection

 
• By Cathy Kelly

The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.

Abbott, J&J Reaffirm 2025 Profit Guidance Despite Growing Tariff Uncertainties

 
• By Marion Webb

Abbott and J&J reassured investors they will maintain their 2025 profit forecasts. Abbott projects $5.05 to $5.25 per share and plans a new $500m investment in manufacturing and R&D sites. J&J anticipates $400m in tariff-related costs but committed $55bn in US investment over four years.

More from Policy & Regulation

New Semiconductor Tariffs Could Raise Device Costs

 
• By Elizabeth Orr

Proposed tariffs on semiconductors from President Donald Trump could significantly raise costs for the US medical device industry. Current domestic production cannot meet demand, spurring concerns about potential price increases for consumers and healthcare systems.

AdvaMed Unveils Its First ‘AI Roadmap’ To Help Lawmakers Navigate Regulating The Technology Through Rocky Times

 
• By Brian Bossetta

Members of AdvaMed’s digital health tech board of directors discussed the organization’s efforts to aid the Trump administration and Congress in answering AI policy questions, especially as companies deal with mounting regulatory uncertainty.

Update: Italy’s IMQ And Belgium’s SGS Named 15th and 16th IVDR Notified Bodies

 
• By Amanda Maxwell

Ireland’s NSAI reinstated under IVD Regulation designation list