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 has an authorized Singapore distributor, HTM Medico, which secured the deal. The contract provides 1,900 defibrillators to the Singapore’s Armed Forces, with about 75% of those going to soldiers in the field and the last quarter to be used in medical centers and for training, according to a press release.
“This is a fantastic achievement for HeartSine, reflecting the worldwide recognition and extremely high quality of our defibrillators," CEO Declan O’Mahoney said in prepared remarks."While this is our largest contract in Singapore, we also have placed HeartSine devices in the Singapore Civil Defence Force, Singapore Parliament and the Ministry of Health."
This is a bit of good news for HeartSine, which is currently in the mud due to issues with the FDA. The Newtown, Penn.-based company late last year recalled some of its defibrillators over concerns about a self-test defect. HeartSine’s troubles continued this week with an FDA warning letter citing medical device reporting and tracking violations at a Pennsylvania facility.
The FDA slapped the company on the wrist for misbranding of the company’s automated external defibrillators and “failure to adequately develop, maintain and implement written [medical device reporting] procedures,” according to the report.
