Inspire Medical Systems has received U.S. Food and Drug Administration (FDA) clearance for its Inspire V therapy system to treat obstructive sleep apnea (OSA).

Inspire Medical Systems用于治疗阻塞性睡眠呼吸暂停（OSA）的 Inspire V 治疗系统已获得美国食品和药物管理局（FDA）批准。

The next-gen system features a new neurostimulator and associated Bluetooth patient remote and physician programmer.

下一代系统具有一个新的神经刺激器和相关的蓝牙病人远程和医生程序员。

Inspire Medical said it’s focusing on operational readiness. This includes product manufacturing and establishing inventory levels to support a full commercial launch in the U.S.

Inspire Medical 表示，公司正集中精力做好运营准备。这包括产品生产和建立库存水平，以支持在美国的全面商业推广。

The company is targeting a soft launch of Inspire V in late 2024, with full launch in 2025.

公司的目标是在 2024 年底试运行 Inspire V，并在 2025 年全面推出。

“We are thrilled to announce the FDA approval of our next generation Inspire neurostimulation system,” said Tim Herbert, chairman and CEO of Inspire Medical Systems. “The FDA approval marks a key milestone for the future of Inspire therapy and reinforces the many years of hard work by our team members.”.

Inspire Medical Systems董事长兼首席执行官蒂姆·赫伯特（TimHerbert）表示：“我们很高兴宣布FDA批准我们的下一代Inspire神经刺激系统。”。“FDA的批准标志着Inspire治疗未来的一个关键里程碑，并加强了我们团队成员多年的辛勤工作。”

Last month, the company earned EU MDR approval for full-body MRI scan conditions with the Inspire OSA therapy. The approval expanded its use labeling, which was previously limited to head, neck, and extremity MRI scans. That approval is retroactive, applying to patients with the Inspire IV neurostimulator device already in place..

上个月，该公司通过Inspire OSA治疗获得了欧盟MDR对全身MRI扫描条件的批准。该批准扩大了其使用标签，以前仅限于头部，颈部和四肢MRI扫描。该批准具有追溯效力，适用于已安装Inspire IV神经刺激装置的患者。

Inspire’s proprietary Inspire therapy is the first and only FDA, EU MDR, and PDMA-approved neurostimulation technology that provides a safe and effective treatment for moderate to severe obstructive sleep apnea.

Inspire专有的Inspire治疗是FDA、EU MDR和PDMA批准的第一项也是唯一一项神经刺激技术，可为中度至重度阻塞性睡眠呼吸暂停提供安全有效的治疗。