Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

FDA's Speedy Apple Watch De Novos Raise Questions For Industry

Executive Summary

The recent US FDA de novo approvals for heart-rhythm analysis software on Apple's latest Apple Watch, which took about 30 days from submission to a decision that aligned with Apple's high-profile launch event, raised eyebrows in the medtech industry. Some in industry are concerned that the tech giant received preferential treatment over smaller companies, setting a bad precedent. But some say it could be a positive sign for the digital health industry at large.

You may also be interested in...



Fitbit Irregular Heart Rate Notification Software Cleared For Use In US

Software for Google’s Fitbit identifies atrial fibrillation using a photoplethysmography algorithm to detect tiny changes in blood volume with its optical sensor.

Minute Insight: FDA Clears Fitbit Irregular Heart Rhythm Notification Feature

The new software for Google’s Fitbit identifies atrial fibrillation using a photoplethysmography algorithm to detect tiny changes in blood volume with its optical sensor.

Artificial Intelligence In Consumer Health: Reality, Challenge And Opportunity

Are self-care apps and digital health wearables touted as powered by AI actually "intelligent"? Currently, no. However, they could be in the future, if regulators can come up with frameworks flexible enough to keep up with adaptive algorithms and machine learning. This article looks at some of the key regulatory issues facing this fast-growing and exciting consumer health market.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

MT123322

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel