Physio-Control said today it agreed to acquire North Irish automated external defibrillator manufacturer HeartSine Technologies for an undisclosed amount. The 2 companies said they completed due diligence but have not released details of the transaction or dates the acquisition is slated to close. “With Physio-Control and HeartSine now united in our lifesaving missions, we will […]
HeartSine Technologies touted some good news, landing a deal with the Singapore Ministry of Defence for the company’s automated external defibrillators.
HeartSine’s AEDs were selected after a competitive process where many different manufacturers submitted bids for the contract. HeartSine was selected for its compact size, light weight and its CPR Advisor, the company said.
HeartSine Technologies is in more hot water with the FDA this month after receiving an agency warning letter citing medical device reporting and tracking violations at a Pennsylvania facility.
HeartSine Technologies issued a voluntary recall of some defibrillators models because of a defect that could lead to death.
The Belfast, U.K.-based medical device company said some of its older PDU 400 personal defibrillators were pulled because of a self-test defect that allows them to appear to be ready for use, despite having insufficient battery power.
The FDA gave HeartSine’s Samaritan defibrillator recall Class I status over concerns that battery issues could lead to patient injury or death.
The Samaritan 300/300P public access defibrillators, which were found to intermittently turn off and on, may be unable to deliver therapy during a cardiac event due to the battery defects.
U.K. medical device maker HeartSine Technologies launched a global correction of its Samaritan 300/300P public access defibrillators over concerns that the devices fail to provide life-saving shock therapy due to a pair of battery defects.
The devices have been loosely linked with 5 deaths that the company has not yet definitively deemed either related or unrelated to the battery issues, HeartSine reported.
Here’s the latest personnel changes from medical device, diagnostics and life science companies around the nation. For more recent hirings and firings, check out MassDevice’s compilation of the latest personnel moves.