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

Podcast: CEO Advises Digital Health Companies To Get Regulatory Help

This article was originally published in The Gray Sheet

Executive Summary

Spencer Hutchins, whose company Reflexion Health's rehabilitation gaming software Vera was recently cleared by FDA says companies like his often have the engineering chops to build medical device software but not the regulatory know-how.

You may also be interested in...



Gaming Console Rehabilitation Program Gets 510(k) Clearance

Reflexion's Vera software that uses Microsoft's Kinect motion-tracking sensor system has been cleared by FDA to treat patients undergoing rehabilitation therapy from home.

FDA Emphasizes “Deregulatory” Efforts In Mobile Medical Apps Final Guidance

In a long-awaited final guidance, FDA affirmed its plan to practice enforcement discretion for most mobile medical apps, except those applications that present the same risks as conventional FDA-regulated devices. Some digital health stakeholders praised the guidance, while others wished FDA has waited.

Cosmetic And Personal Care Trademark Review: 16 April

Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT034414

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