On June 11, Ivenix received 510(k) clearance from the Food and Drug Administration (FDA),
a goal Ivenix’s team had been working toward for three years.
In medicine, human error is like a plague: It spreads easily and kills often.
Recent studies of medical errors estimate that they could account for as many as 251,000 deaths annually in the US, making medical errors the third leading cause of death. And though technology can help to reduce these medical mistakes, it can also exacerbate them.
IV infusion pumps hold significant potential for these errors. Many pumps have confusing interfaces, inefficient alarm systems, and complex programming protocols. A multihospital study published in BMJ Quality & Safety in 2016 found that 60 percent of IV infusions had at least one error associated with their administration (although the same study notes that very few of these were potentially harmful).
Ivenix, a biotech startup based in North Andover, aims to change that. The company’s infusion pump, or “infusion system” as Ivenix prefers to call it, has an interface similar to a smartphone. Some of its features include an easily adjustable height, a drug library that automatically recommends dosages, and a feature that automatically sends patient info to electronic health record systems. “We think we can really make a dent in those adverse drug events which are just all over the place in healthcare today,” said Susan Niemeier, Ivenix’s chief nursing officer.
Ivenix was founded about seven years ago as a rebranding of Fluidnet Corporation. It is backed by several large investors, including FPrime and Wuxi Tech.
On June 11, Ivenix received 510(k) clearance from the Food and Drug Administration (FDA), a goal Ivenix’s team had been working toward for three years.
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