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Acurable Secures FDA Clearance for Innovative Sleep Apnea Testing Device, Set to Launch in the US

London-based medical device company Acurable is set to launch its AcuPebble device for diagnosing obstructive sleep apnea (OSA) in the United States. Following a successful launch in Europe, Acurable aims to revolutionize sleep apnea detection for Americans. The device offers a patient-friendly and efficient solution for OSA diagnosis, allowing for remote and efficient home testing. By providing earlier detection, faster treatment, and improved management of this chronic condition, the AcuPebble device has the potential to make a significant impact.

The AcuPebble device has received clearance from the US Food and Drug Administration (FDA) and is already being used by the National Health Service (NHS) in the UK to improve the current time-consuming home sleep apnea diagnosis method. Currently, the testing process for sleep apnea is complex and expensive, with a majority of cases going undiagnosed worldwide. Acurable's AcuPebble device offers a cheaper, faster, safer, and more patient-friendly solution.

The AcuPebble device is easy to use, requiring the patient to attach the sensor to the front of their neck before going to sleep. The sensor transfers the signals to a mobile device, which uploads the data to a secure platform. A doctor then receives a report with a diagnosis, enabling automated diagnosis of OSA.

The device's clearance from the FDA and its upcoming launch in the US market mark significant milestones for Acurable. With an estimated 25 million adults in the US affected by OSA, the device's introduction has the potential to improve the lives of many individuals by facilitating easier and more accessible sleep apnea testing.

Acurable's innovative approach to sleep apnea detection, coupled with its successful track record and the FDA clearance, positions the company as a leader in the field. The company's commitment to delivering effective and patient-centered solutions for sleep apnea underscores its dedication to improving healthcare outcomes in the US and beyond.

https://acurable.com/en/blog/acupebble-ox100-fda-clearance


 

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