Summary: Signifier Medical Technologies’ eXciteOSA, a daytime therapy for obstructive sleep apnea, has received EU MDR certification, validating its safety, efficacy, and potential for broader adoption across European markets.
Key Takeaways:
- The EU MDR certification eXciteOSA earned is recognized globally for ensuring that medical devices meet requirements for quality, safety, and clinical evaluation.
- Signifier expects this will facilitate broader adoption of the daytime therapy for snoring and mild OSA.
Obstructive sleep apnea (OSA) therapy eXciteOSA, marketed by Signifier Medical Technologies Ltd, has achieved the European Union (EU) Medical Device Regulation (MDR) certification. The EU MDR certification is recognized globally for ensuring that medical devices meet requirements for quality, safety, and clinical evaluation.
According to Signifier, the EU MDR certification paves the way for broader adoption of eXciteOSA across European markets, enhancing accessibility.
“Achieving EU MDR certification is a significant milestone for Signifier Medical Technologies and a testament to the hard work and dedication of our entire team,” says Mujtaba Chohan, head of finance and director at Signifier, in a release. “This certification underscores our commitment to providing safe, effective, and cutting-edge solutions that improve the lives of patients with obstructive sleep apnea worldwide.”
“eXciteOSA is reshaping the treatment landscape for obstructive sleep apnea,” says Yasser Zayni, head of commercial, clinical, and compliance at Signifier, in a release. “The EU MDR certification ensures that more individuals in need can access this transformative treatment, showcasing its potential to positively impact public health across Europe and beyond. This certification validates the clinical efficacy of the treatment, and I am delighted that many more people struggling with obstructive sleep apnea will now have the opportunity to benefit from it.”
In 2021, the US Food and Drug Administration authorized marketing of eXciteOSA to reduce snoring and mild OSA. Unlike devices used while patients sleep, eXciteOSA is used while awake and is intended to improve tongue muscle function, which in time can help prevent the tongue from collapsing backwards and obstructing the airway during sleep.
