Baxter secures FDA clearance for delayed Novum IQ infusion pump

Baxter has secured 510(k) clearance for its large-volume infusion pump (LVP) Novum IQ after a three-year process with the FDA.

Initially flagged by the FDA in 2022, Baxter's submission for LVP Novum IQ clearance was put on hold. After a final resubmission in early 2023, clearance was granted a year later.

During the review, the LVP market evolved. Initially hindered by supply constraints, Baxter's Spectrum pump couldn't fully compensate for Novum IQ's delay. However, Baxter resolved these issues, establishing Spectrum as a growing product.

Evercore analysts suggest Novum IQ's projected impact shifted from the initial $100 million estimate to a smaller, incremental contribution. Despite this, Novum IQ's advantages position it well to gain market share.

Stifel analysts anticipate Novum LVP driving significant annual sales contributions, potentially ranging from $25 million to $100 million, with a gradual commercial rollout expected throughout the year.

While awaiting further details from Baxter, Stifel analysts have kept their financial estimates unchanged. Baxter has announced Novum IQ's availability for orders in the U.S.