As regulated companies, medical device firms must stay abreast of the latest developments to ensure they adopt new protocols to maintain quality assurance.
David Jensen, Staff Writer, MasterControl 04.09.21
The wearable sensor is now recognized as a medical device in Europe, capable of providing continuous, medical-grade measurements of a person’s activity.
The next generation INS approved by Health Canada reduces how frequently a patient needs to recharge their implanted device to once a month for about one hour.
The Acclaim device offers the benefits of traditional partially implanted cochlear implants without the external components and associated disadvantages.
Agency claims ID NOW may return false negative results; Abbott says some studies are investigating the test's role in ways it was not meant to be used.
Mike Drues and Sean Fenske discuss real world evidence and several reasons why it’s not being used by medical device manufacturers for regulatory review.
MPO Editor-in-Chief Sean Fenske speaks with Scott Whitaker, AdvaMed President and CEO, about how the medtech industry is assisting in the COVID-19 effort.