Zynex Inc. Submits FDA Application for Revolutionary Pulse Oximeter
October 2023 — Zynex Inc. (NASDAQ: ZYXI) has officially submitted a groundbreaking non-invasive pulse oximeter to the U.S. FDA, as announced by CEO Thomas Sandgaard in a recent interview with Proactive.
The innovative device aims to enhance the accuracy of oxygen level readings, particularly for individuals with darker skin tones and those suffering from conditions like carbon monoxide poisoning. Sandgaard highlighted significant flaws in current market devices, which often provide inaccurate readings under these critical circumstances. This innovation addresses urgent needs expressed by the medical community and regulators for more reliable healthcare solutions.
"Pulse oximetry is one of the most significant markets for medical devices worldwide, yet the prevailing technology largely fails to deliver accurate data, especially concerning skin tone and certain medical conditions," Sandgaard stated. He noted that existing devices can misinterpret blood oxygen levels, leading to unnecessary blood tests in emergency situations.
Zynex’s pulse oximeter utilizes advanced laser diode technology, unlike conventional devices that rely on standard LEDs. This allows for precise readings, including the detection of carbon monoxide, without requiring invasive procedures. The company aims to target the hospital market first, which generates approximately $1 billion in annual revenue.
Following the submission, Sandgaard expressed optimism about the FDA’s review process, anticipating a timeline of about six months for clearance. He emphasized that this technology is a crucial advancement that could significantly impact patient care, especially highlighted during the COVID-19 pandemic when disparities in data accuracy were exposed.
The FDA’s interest in Zynex’s innovation stems from pressures to address inequities in healthcare delivery, particularly evidenced by higher mortality rates for individuals with darker skin during the pandemic.
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