FDA 批准了首款非处方指尖脉搏血氧仪 MightySat Medical，消费者无需处方即可购买。 FDA clears first OTC fingertip pulse oximeter, MightySat Medical, for consumer purchase without prescription.
Masimo Corp. 的 MightySat Medical 已获得 FDA 批准，这是首款经 FDA 批准的医用指尖脉搏血氧计，无需处方即可直接向消费者提供非处方药 (OTC)。 Masimo Corp. has received FDA clearance for its MightySat Medical, the first FDA-cleared medical fingertip pulse oximeter available over-the-counter (OTC) directly to consumers without a prescription. 该设备采用 Masimo SET® 脉搏血氧测定技术，与世界各地的医院和诊所所使用的技术相同，现在可以在 masimo.com 上购买。 The device utilizes Masimo SET® pulse oximetry technology, the same used in hospitals and clinics worldwide, and is now available for purchase at masimo.com. 经 FDA 批准的 MightySat Medical 旨在在不运动的情况下准确测量 18 岁及以上个体的氧饱和度和脉搏率，不适用于诊断或筛查肺部疾病。 The FDA-cleared MightySat Medical is designed to accurately measure oxygen saturation and pulse rate for individuals aged 18 and older, under no motion conditions, and is not intended for the diagnosis or screening of lung diseases.