Business Insider

Innovative Health Receives FDA Clearance to Reprocess the PENTARAY® Nav Eco High-Density Mapping Catheter, Providing Dramatic Potential Savings for Hospitals

SCOTTSDALE, Ariz., June 28, 2019 /PRNewswire-PRWeb/ -- Innovative Health, the leading single-use cardiology medical device reprocessing company, today announced it has received FDA clearance for ...
Business Wire

CORRECTING and REPLACING Innovative Health Receives FDA Clearances to Reprocess St. Jude Medical’s Advisor™ FL, Two Medtronic Diagnostic Catheters and Biosense Webster’s ...

PHOENIX--(BUSINESS WIRE)--Second paragraph, second sentence of release dated November 26, 2018, should read: It remains the only reprocessor to gain FDA clearances for the ViewFlex Xtra by St. Jude.
RAPS

FDA Unveils List of Reusable Devices Requiring New Validation Data

Following superbug outbreaks after issues with reprocessing certain medical devices, the US Food and Drug Administration (FDA) on Thursday released a list of devices that the agency will require ...
JD Supra

Trust the reProcess? A Practical and Legal Overview of Reprocessing Single-Use Medical Devices in the United States

Allow me to set the stage. Our plaintiff claims he felt a nagging pain in his shoulder for months and finally went to see the local orthopedic surgeon. The surgeon apparently informed him that the ...
RAPS

Duodenoscope Reprocessing: Interim Study Results Indicate Higher Contamination Rates

Interim results from the US Food and Drug Administration’s (FDA) mandated postmarket surveillance studies of duodenoscopes indicated a “higher-than-anticipated contamination rates after reprocessing,” ...