Wearables and Sensors – Webinar Recording/Transcript
Wearables and Sensors: Recent Developments in a Booming Field
The rapidly evolving landscape for wearables and sensors is having a mighty impact.
Former FDA staff member Sugato De, MS — Vice President, Parexel International — and regulatory expert Peter Steiger — Vice President, Parexel Informatics — will explain what you need to know and share management strategies to make it all work for your organization.
- Which wearables and sensors need FDA approval
- How to comply with the FDA’s final guidance on assessing wellness products
- How the FDA assesses low-risk devices
- Why blood pressure monitoring (through wearables and sensors) represents a new frontier in FDA regulation and should be watched closely by all device manufacturers
- Why Dexeco decided to partner with Apple and Fitbit as part of its strategy to get approval for their glucose-monitoring devices
- Why Kardia Band from AlvieCor — which allows Apple Watch users to track their EKG from their wrists — was approved and what it means for other wearables
- Why the ingestibles category is one of the big new developments in the future of wearables (including the recently approved Abilify and MyCite)
- Why device manufacturers need to keep a close watch on companies that provide biometric information
- How the FDA’s pilot program — which includes big wearables players like Apple, Fitbit and Samsung — provides a basis for fast-tracking your wearables and sensors
- How to conduct clinical trials involving wearables and sensors
These experts will show you how to assess the value of adopting innovation in medical device and drug development; as well as discuss the recent/ongoing changes in the regulatory ecosystem so you can streamline regulatory approvals and achieve commercial success! Join us by registering today.