Ivenix said today that its infusion system won 510(k) clearance from the FDA.
The large-volume pump and infusion system features a “smartphone-like” user interface and a suite of administration tools to remotely monitor infusions, according to Ivenix.
The Boston-based company reported that infusion-related adverse drug events make up more than $2 million in healthcare costs per year. The company’s pump is designed to reduce medication errors and related costs, Ivenix touted.
“We started out knowing that in order to effectively solve today’s medication safety concerns, we needed to build more than a pump,” CTO George Gray said in prepared remarks.
“Instead, we built an infusion system that is centered around patients and provides the rich information clinicians need to make safe decisions. In our efforts to make the pump safer, we challenged the status quo and eliminated many of the error-prone tasks that result in preventable adverse drug events. In addition, we examined all the costs associated with owning and operating a pump and found ways to significantly reduce those costs for the hospital. We’re pleased that the FDA cleared our next-generation infusion system. We believe it will dramatically transform the industry,” Gray added.