Simplifying Global Compliance
Wearables and Sensors – Webinar Recording/Transcript
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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.
Webinar Takeaways:
- 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.
- Regulatory affairs professionals
- Product development specialists
Sugato De, MS, is a Vice President at Parexel International, where he supports medical device and pharmaceutical companies on regulatory, clinical and performance validation strategies. Mr. De has specialized expertise with combination products, digital health, and custom devices. Prior to joining Parexel, he spent more than 11 years with CDRH at FDA, including as the Branch Chief of the Respiratory Devices Branch and more recently as a Senior Policy Advisor in the Office of the Center Director.
Peter Steiger is Vice President, Parexel Informatics. He has a wealth of experience in the use of imaging in academic research, medical device development and clinical trials management. Mr. Steiger’s responsibilities include both the oversight of the medical team as well as the expansion of Parexel’s Medical Imaging business into new areas. He started his academic career at the University of California, San Francisco where he was involved in multiple publicly and privately funded research projects in skeletal radiology. In 1990, Mr. Steiger left academia to work at Hologic, Inc. as Chief Scientist. During his tenure at Hologic, he also created a division that provided image quality assurance services to pharmaceutical companies in support of clinical trials. Later, Mr. Steiger also served as CEO of both Synarc, Inc., a privately held, venture-backed company for the support of imaging in clinical trials, and Optasia Medical LTD, which makes and sells FDA cleared software that is used in a point-of-care setting for the documentation of vertebral fractures. Throughout his career, Mr. Steiger has been actively engaged in research, has authored numerous papers and is regularly involved in research presented at scientific meetings.
