ZOLL First Company to Receive FDA's Premarket Approval on Defibrillators

ZOLL First Company to Receive FDA's Premarket Approval on Defibrillators

Press Release Jan 09, 2018

January 9, 2018—Chelmsford, Mass.—ZOLL® Medical Corporation, a manufacturer of medical devices and related software solutions, today announced that it is the first company to achieve premarket approval (PMA) by the U.S. Food and Drug Administration (FDA) to continue to market and distribute its full line of defibrillators in the U.S.

The list of defibrillators which received PMA approval include the R Series® and X Series®monitor/defibrillators and the AED Pro® and AED Plus® automated external defibrillators. All of these devices are equipped with ZOLL’s proprietary rectilinear biphasic waveform to deliver maximum current to high-impedance patients and Real CPR Help® technology that helps rescuers perform high-quality CPR.

 “ZOLL is very pleased to have received PMA approval for our entire portfolio of defibrillators,” said A. Ernest Whiton, President of ZOLL’s Resuscitation division. “This is the most stringent level of regulatory approval for safety and efficacy of a medical device, and represents ZOLL’s long-standing commitment to product quality, safety, and efficacy.”

The acquisition expands Tri-Tech’s product offering to include first responder kits and emergency supplies.
CMC Rescue today marked its 40th anniversary year with a refreshed name and website and plans to introduce a series of products for rescue and rope access markets.
Boostlite® and Draftlite® become standard equipment on select FIRELITE® skid units.
New bleeding control technology is now being carried by select units in EMS, fire and law enforcement.
MedixSafe is the first manufacturer to require triple authentication on a narcotics cabinet, including a PIN, card and fingerprint.
The FDA approved ZOLL's entire portfolio of defibrillators to continue to be marketed and distributed.
Slotted Variable Mounts are designed to provide improved flexibility and customization when laying out and mounting to 1”x1” tool board grids.
The portable field kit enables the Transformer® scene light to be stored, transported and set up more conveniently.
The DPA Buying Group has welcomed thirteen new distributor members to its public safety products division.
The Parmarlow Foam Eartip fits comfortably in the ear to block out ambient noise.
What were the most pioneering new and reimagined EMS products and services of 2017?
We close 2017 with our annual Buyer’s Guide, plus a lot more.
Medline is one of the first to achieve a fentanyl-resistant product in response to the growing opioid epidemic.
PH&S looks to expand applications for its fentanyl-resistant glove to ensure the safety of first responders and healthcare personnel who come in contact with the substance.