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医疗技术公司Inspire Medical Systems治疗阻塞性睡眠呼吸暂停Inspire V系统获FDA批准

FDA approval for Inspire V therapy system to treat obstructive sleep disorder

medthority 等信源发布 2024-08-11 11:00

可切换为仅中文


Inspire Medical Systems, In a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with obstructive sleep apnea (OSA), announced the FDA approval of the Inspire V therapy system  which includes the next generation neurostimulator and the associated Bluetooth patient remote and physician programmer.

Inspire Medical Systems是一家专注于为阻塞性睡眠呼吸暂停(OSA)患者开发和商业化创新微创解决方案的医疗技术公司,该公司宣布FDA批准Inspire V治疗系统,该系统包括下一代神经刺激器和相关的蓝牙患者远程和医生程序员。

The company’s focus remains on operational readiness, which includes product manufacturing and establishing inventory levels to support a full commercial launch in the United States. The company continues to target a soft launch in late 2024 and a full launch in 2025.

该公司的重点仍然是运营准备,其中包括产品制造和建立库存水平,以支持在美国的全面商业推出。该公司的目标是在2024年末实现软发布,并在2025年实现全面发布。