Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

Masimo Announces FDA 510(k) Clearance for TFA-1™ Single-Patient-Use Forehead Sensor

December 19, 2016 By Business Wire

–Masimo (NASDAQ:MASI) announced today FDA 510(k) clearance for the TFA-1™ Single-Patient-Use Adhesive Forehead Sensor. This single-patient-use sensor allows clinicians to monitor patients using Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry from an alternative monitoring site, the forehead, rather than a finger.

Masimo TFA-1 Single-Patient-Use Adhesive Forehead Sensor (Credit: Business Wire)

Forehead sensors may provide oxygen saturation measurements that are less susceptible to peripheral perfusion changes, and were shown in a 2004 study to have faster detection of desaturation and resaturation, as compared to digit sensors.1 Forehead sensors can also be easily accessed during surgery and resuscitation and on patients with finger deformities or whose fingers are not accessible. As a single-patient-use sensor, TFA-1 avoids the management complexities (cleaning, storage, and inter-department transport) that accompany reusable sensors.

Masimo SET® includes measurement of oxygen saturation (SpO2), pulse rate (PR), perfusion index (PI), and PVI®, a measure of the dynamic changes in PI that occur during the respiratory cycle. Masimo SET® addresses the challenges of low perfusion and motion artifact that limit conventional pulse oximetry by harnessing the power of adaptive filters to reduce measurement inaccuracy. Masimo SET® helps clinicians monitor more than 100 million patients a year2 and is used by 8 of the top 10 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.3

Related Articles Read More >

DeepWell Digital Therapeutics Mike Wilson Ryan Douglas
How DeepWell is developing video games as tools for treating medical conditions
A woman with a small, handheld device in her lap with tubes that look like earphones plugged into her ears.
Ear-puffing device for migraine treatment wins FDA breakthrough designation
Abbott
Abbott launches upgraded digital health app for neurostimulation
Catheter delivery could enable better brain implants: Synchron’s neuroscience chief explains how

DeviceTalks Weekly.

May 13, 2022
Our Pre-Post-DeviceTalks Boston episode, also MedtronicTalks replay with Gastro CMO Austin Chiang
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

Enewsletter Subscriptions

Enewsletter Subscriptions

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
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • 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 E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. 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
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech