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| Cardiac Science is selling off the business that makes its Burdick ECG.--Courtesy of Cardiac Science |
Cardiac Science is parting ways with some of its mainstay technologies, selling its diagnostic cardiology unit to Mortara Instrument and doubling down on its automated external defibrillator business.
Neither company is releasing financial details, but they did specify that the deal covers Cardiac's Burdick and Quinton brands of heart diagnostic devices, which will fold into Mortara's ECG offerings. Cardiac will keep its wearable ECG recorder, MySense, and its entire line of external defibrillators, the company said.
"Divestiture of the diagnostic cardiology product line will bring more strategic focus to Cardiac Science," CEO Neal Long said in a statement. "The company will now be able to exclusively focus on innovation and the expansion of market share in its high-margin resuscitation business."
The move comes as the FDA is proposing to tighten its regulations on external defibrillators, which could lead to spiking costs for their manufacturers. Currently, the devices are cleared through the 510(k) process, but, concerned with their safety, the agency wants to subject them to PMA rigors, asking companies to provide data before allowing them to stay on the market.
The switch from clearance to a full PMA would mean paying $220,000 instead of $5,000 for device approval, according to the FDA, but companies like Cardiac Science would only have to fork that over once for multiple models.
- read the announcement