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News We're Watching: AliveCor Suit Dismissed, IMDRF Comes To DC, Digital Health Caucus

 
• By Brian Bossetta and Hannah Daniel

This week, AliveCor's patent infringement lawsuit against Apple came to an end; industry stakeholders submitted comments to the FTC on the right to repair; Cardinal Health and Percussionaire announced recalls; and the IMDRF announced a March meeting in Washington, DC.

Regulatory News We're Watching
• Source: Shutterstock

A Federal District Court in Northern California has dismissed AliveCor Inc.’s antitrust lawsuit against Apple on 6 February, meaning Apple will not have to face a trial.

AliveCor filed the case on 26 May, 2021,

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Faster Device Certification Among Keys To Unlocking Innovation In EU MedTech Sector

 
• By Amanda Maxwell

While MedTech Europe sharpens its focus on what the EU most urgently needs to advance the medtech market in four targeted measures, the European Commission has also unveiled four priorities for 2025.

MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 
• By Amanda Maxwell

The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.

FDA Announces Classifications On 8 Device Types

 
• By Elizabeth Orr

The US Food and Drug Administration has announced new classifications for eight device types that reached market via the de novo process, with most of the newly classified products in the diagnostics sector.

Medical Devices Not The Focus Of FDA’s Plans To Step Up Foreign Inspections, Expert Says

 
• By Brian Bossetta

The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.

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