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Coastal States Among Most Costly Device Manufacturing Locales – Report

Domestic device manufacturing facility operating costs run higher at locations including California, Connecticut and Massachusetts, but come in lower at sites such as South Dakota, Kentucky and Alabama, according to a recent study of 55 production sites in the U.S. and near-shore alternatives.

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Nyxoah Launches FDA-Cleared Genio System For OSA As Rival Inspire Files Patent Suit

 
• By Marion Webb

After receiving FDA clearance for its Genio sleep apnea implant, Nyxoah plans a major US rollout despite a patent suit from rival Inspire Medical. Genio offers bilateral nerve stimulation as a CPAP alternative, with strong trial results.

Inaccurate Carbon Dioxide Readings Prompt Class I Recall Of Draeger Ventilation Filters

 
• By Brian Bossetta

Draeger Medical has recalled certain SafeStar and TwinStar ventilation filters after reports of serious injuries caused by misleading carbon dioxide readings.

UK MHRA Ready To Evolve Approach To In-House Manufactured Medtech

 
• By Ashley Yeo

The UK device regulator wants to align health institution device exemptions with its evolving policy of agile regulation of medtech in the British market. It asks stakeholders to complete a survey by Sept. 15.