FDA warns Non-Invasive Monitoring Systems over device marketing

03/28/2011 | MassDevice.com (Boston)

Non-Invasive Monitoring Systems has received an FDA warning letter saying the company is promoting its Exer-Rest whole body periodic acceleration device for off-label uses. The company counters that its product has status as a Class I exempt device, claiming that 510(k) clearance studies and medical device premarket approval aren't necessary.

View Full Article in:

MassDevice.com (Boston)

Published in Brief:

SmartBrief Job Listings for Health Care

Job Title Company Location
Sr. Medical Device Reimbursement Specialist - Regional
Alcon
Fort Worth , TX
Assistant General Counsel/Senior Corporate Counsel - Healthcare Law Group
Genentech
94080, CA
Clinical Trials Agreements Specialist (209955)
The Henry M. Jackson Foundation for the Advancement of Military Medicine Inc.
Rockville, MD
SAFETY, HEALTH, and ENVIRONMENTAL (SHE) REGIONAL SPECIALIST
Matheson Tri-Gas, Inc.
Newark, CA
MANAGER MEDICAL GAS COMPLIANCE AND SAFETY
Matheson Tri-Gas, Inc.
Houston, TX