Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Educational Assets
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe

Consumer Sleep Technology Is No Substitute For Medical Evaluation

May 16, 2018 By American Academy of Sleep Medicine

According to a position statement from the American Academy of Sleep Medicine (AASM), consumer sleep technology must be cleared by the Food and Drug Administration (FDA) and rigorously tested if it is intended to diagnose or treat sleep disorders.

Consumer sleep technologies are non-prescription devices such as wearables and mobile apps that are directly marketed to consumers to monitor sleep, improve sleep quality, or screen for sleep disorders. However, there are minimal data validating the ability of these devices to accurately perform these functions, and to date almost no consumer sleep devices have undergone review by the FDA.

The lack of validation data and absence of FDA clearance raises concerns about the accuracy of consumer sleep technology. Therefore, it is important for health care providers to understand the capabilities and limitations of these devices.

“Given the heightened public awareness of the importance of sleep, and of diagnosing and treating sleep disorders, I believe we will continue to see more patient-generated health data,” said lead author Dr. Seema Khosla, the medical director of the North Dakota Center for Sleep in Fargo. “We need some guidance both for how to utilize consumer sleep technology in our practice and also how to communicate with our patients about the specific metrics their devices are measuring.”

The position statement is published in the May 15 issue of the Journal of Clinical Sleep Medicine.

As the popularity of consumer sleep technology continues to grow, clinicians are increasingly asked to analyze patient-generated health data. However, health care providers must recognize that this data should be considered in the context of a comprehensive sleep evaluation and should not replace validated diagnostic testing.

“While technology is advancing rapidly, and we are following the trends closely, consumer sleep devices currently are unable to diagnose sleep disorders,” said AASM President Dr. Ilene Rosen. “Individuals who are dissatisfied with their sleep, experiencing an ongoing sleep problem, or struggling with excessive daytime sleepiness or fatigue should discuss this important issue with a licensed medical provider, regardless of what their wearable or other consumer sleep technology device tells them.”

Despite their limitations, consumer sleep devices may increase awareness of the importance of sleep and the potential presence of a sleep disorder. Therefore, this technology can promote meaningful interactions between patients and clinicians when discussed during an appropriate clinical evaluation.

“I, like many of my colleagues, have seen more patients presenting to the sleep clinic to discuss their abnormal data,” said Khosla. “They are looking for ways to improve their sleep and reaching out to their local sleep specialists for guidance. I believe consumer sleep technology allows us to partner with our patients to improve their sleep.”

Related Articles Read More >

Benefits of thermoplastic polyurethane films for wearable devices
Wyss Institute researchers develop coating to extend lifespan of implantable biosensors
A photo of Medtronic's LINQ II implantable cardiac monitor.
Lessons from Medtronic’s Define AFib study of implantable cardiac monitors
FDA logo
FDA releases draft guidance for pulse oximeter accuracy
“mdo
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest medical device business news, application and technology trends.

DeviceTalks Weekly

See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech100 Index
  • Medical Tubing + Extrusion
  • Medical Design Sourcing
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to our E-Newsletter
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2025 WTWH Media, LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media LLC. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Educational Assets
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe