Hospira gets FDA nod for wireless infusion pump, finishing up two-year plan to reinvigorate devices

Hospira CEO F. Michael Ball

Hospira ($HSP) hopes to get back on track with its infusion pump business this year. The latest bit of good news for the company is FDA clearance for the Plum 360 Infusion System, which adds the capability to wirelessly stream data to an electronic medical record (EMR) and access an expanded drug library for information to maintain patient safety. It can also distinguish between two different infusion lines and deliver drugs via them at the appropriate rates.

The news comes within a few months of FDA lifting an import ban on a Hospira infusion pump manufacturing site and a clearance by the agency of another new infusion pump--this one aimed at large-volume infusion, SapphirePlus.

In May 2013, the company laid out a plan to turn about its medical devices business. It included getting back on track with manufacturing quality, getting rid of outdated infusion pumps and launching new infusion pumps. Hospira has said it expects to complete this by the second half of 2015. The Plum 360 U.S. launch is expected "in the coming weeks," Hospira said in a statement.

"The FDA actually lifted our import ban such that we can start to sell our machines again in the United States. We're progressing nicely with our device action plan, and that should wrap up in 2015," Hospira CEO F. Michael Ball said at the recent JP Morgan Healthcare conference last week. He continued, "And in 2014, we submitted two new 510(k)s for next generation devices to the FDA. I'm pleased to say they've already approved one, the SapphirePlus, and we look forward to the Plum 360 getting approved in the near future. So as I step back and look at the device business then, things are moving in the right direction and we will get on the front foot with devices starting in 2015."

Ball said that Hospira is the global leader in injectable pharmaceuticals and infusion devices, with the former accounting for 70% of its portfolio and the latter accounting for about 20%.

During the first three quarters of 2014, the company brought in 19% of its $3.3 billion in net sales through its Medication Management business that includes infusion pumps as well as related software and services.

- here is the release