CALGARY, AB (November 23, 2020) — Zephyr Sleep Technologies Inc. (Zephyr), a leader in the field of dental sleep medicine, is announcing the US Food and Drug Administration (FDA) has granted 510(k) premarket notification clearance for eliminating the requirement for a nasal cannula during a sleep theragnostic test.
Zephyr’s latest innovation to the MATRx plusTM makes setting up the take-home sleep appliance Treatment Planning test simpler for the patient and easier for the Dental team to dispense. The MATRx plus now delivers a better patient experience, empowers dental teams, increases case acceptance, with the same industry-leading accuracy and reliability as before, but with one less connection to worry about. With only a single fingertip pulse oximetry probe needed for testing, patients will have a more comfortable sleep with fewer disturbances.
By using MATRx plus Treatment Planning, clinicians can easily and quickly determine WHO can be treated with oral appliance therapy and HOW to configure the oral appliance for therapeutic effectiveness.
- Improved patient experience and increased patient comfort with a simpler set-up
- Fewer alerts equate to fewer patient disturbances. Alerts were reduced by 73% during testing
- Accuracy and reliability remain at an industry leading level
- 97% accuracy in identifying OAT responders
- 89% accuracy in identifying therapeutic position
- Fewer connections mean fewer potential errors and fewer alerts
- Zephyr continues to innovate and improve the product platform
All existing MATRx plus users who are Connected Program subscribers will receive this innovation, at no additional charge, as all software updates are included within the subscription.
“Over 375 dentist offices in North America now use MATRx plus. Dentists and their teams tell us it’s all about the importance of delivering a better patient experience. With this latest innovation, we’ve made a simple test and workflow even easier” Paul Cataford, CEO & Co-founder, Zephyr.
“This is breakthrough technology that improves patient comfort, reduces nighttime interruptions and without compromising predictive accuracy. This innovation is extraordinarily important to the advancement of predictive oral appliance therapy, which can be nearly 100% effective when using MATRx plus.” Dr. John E. Remmers, Chief Medical Officer & Founder, Zephyr
Zephyr remains focused on continuous improvement, while also providing the best, most accurate and reliable at-home sleep theragnostic test experience for patients. Zephyr’s Technology team is using its knowledge and expertise to deliver state-of-the-art technology to the dental sleep medicine community.
About Zephyr Sleep Technologies
Zephyr Sleep Technologies helps people live healthier, more productive lives by sleeping better. The company provides medical professionals with modern, precise and easy-to-use medical devices. All Zephyr products are approved by Health Canada and cleared by the FDA after extensive and rigorous clinical trial testing and validation. Our mission is to create products and empower workflows that are easy to implement and use – simply, better sleep care. The company is headquartered in Calgary, Alberta and was founded in 2010.