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医疗设备制造商Zynex新型疼痛管理设备获FDA批准

Zynex Obtains FDA clearance for new Pain Management Device

Zynex 等信源发布 2024-09-03 21:26

可切换为仅中文


ENGLEWOOD, Colo., Sept. 3, 2024 /PRNewswire/ -- Zynex Inc. (NASDAQ: ZYXI), a leading medical technology company specializing in non-invasive medical devices for pain management and rehabilitation, today announced FDA clearance of its new TensWave device.

科罗拉多州恩格伍德,2024年9月3日,专注于疼痛管理和康复非侵入性医疗器械的领先医疗技术公司Zynex Inc.(纳斯达克:ZYXI)今天宣布FDA批准其新的TensWave设备。

The TensWave device, by prescription only, builds on Zynex's strong legacy of innovation in pain management. It offers a user-friendly, portable design that can be easily integrated into patients' daily routines. The device aims to provide effective pain relief through TENS (Transcutaneous Electrical Nerve Stimulation) therapy, which has been clinically proven to reduce chronic and acute pain without needing medication..

TensWave设备仅凭处方,建立在Zynex在疼痛管理方面的强大创新遗产之上。它提供了一种用户友好的便携式设计,可以轻松地整合到患者的日常生活中。该设备旨在通过TENS(经皮神经电刺激)疗法提供有效的疼痛缓解,该疗法已被临床证明可以减轻慢性和急性疼痛,而无需药物治疗。。

'The introduction of TensWave aligns perfectly with our commitment to providing comprehensive pain management solutions,' said Thomas Sandgaard, CEO of Zynex Medical. 'We recognized a gap in the market for a high-quality TENS device that meets the specific criteria for insurance reimbursement, and TensWave is our answer to that demand.

Zynex Medical首席执行官托马斯·桑德加德(ThomasSandgaard)说,TensWave的推出与我们提供全面疼痛管理解决方案的承诺完全吻合我们认识到市场上对于高质量TENS设备的差距,该设备符合保险报销的具体标准,TensWave是我们对这一需求的回应。

It complements our flagship multi-modality device, the NexWave, where Interferential current is the main modality and driver of obtaining prescriptions. This device broadens our product portfolio and enhances our support to patients.'.

它补充了我们的旗舰多模式设备NexWave,其中干扰电流是获得处方的主要模式和驱动因素。该设备拓宽了我们的产品组合,增强了我们对患者的支持。”。

It is important to note that the TensWave device is not intended to replace our market-leading NexWave electrotherapy device, which remains the top choice for patients seeking a comprehensive electrotherapy solution but in certain instances, can provide flexibility in dealing with patients' insurance coverage.

值得注意的是,TensWave设备并不是要取代我们市场领先的NexWave电疗设备,NexWave电疗设备仍然是寻求综合电疗解决方案的患者的首选,但在某些情况下,它可以在处理患者保险范围时提供灵活性。

The TensWave is a complementary product designed for those whose insurance plans exclusively cover TENS therapy..

TensWave是为那些保险计划专门涵盖TENS治疗的人设计的补充产品。。

The TensWave is poised to become an essential tool for patients suffering from chronic pain conditions, offering them a safe, effective, and drug-free alternative to pain management. It complements our offerings of electrotherapy products, cervical traction, braces, cold/hot therapy and compression devices..

TensWave有望成为慢性疼痛患者的重要工具,为他们提供安全,有效且无药物的疼痛管理替代方案。它补充了我们提供的电疗产品、颈椎牵引、支架、冷热疗法和压迫装置。。

This new product clearance by the FDA marks another milestone in Zynex's ongoing mission to improve patient outcomes through innovative medical technology.

FDA的这项新产品许可标志着Zynex通过创新医疗技术改善患者预后的持续使命的另一个里程碑。

About Zynex Inc.

关于Zynex Inc。

Founded in 1996, Zynex develops, manufactures, markets, and sells medical devices used for pain management and rehabilitation, as well as non-invasive monitoring systems for use in hospitals. For more information, please visit: www.zynex.com.

Zynex成立于1996年,开发、制造、营销和销售用于疼痛管理和康复的医疗设备,以及用于医院的非侵入性监测系统。有关更多信息,请访问:www.zynex.com。