- Iradimed Corporation IRMD voluntarily withdrawn its 510(K) application for its next-generation MRidium 3870 infusion pump system.
- Roger Susi, the company’s President and Chief Executive Officer, commented, “The FDA has requested additional information that could not be provided within the FDA review period. As such, we have decided to withdraw our application to give us more time to understand FDA matters and resolve concerns.”
- We are confident that after working with the FDA, we will be able to file a 510(k) submission leading to timely approval for the MRidium 3870 infusion pump system.
- The company also expects third-quarter revenue of about $13.4 million, up 23% year over year and ahead of its guidance of $13.1 million to $13.3 million.
- “These preliminary third quarter results represent our best-ever revenue quarter. It also continues a four-quarter trend of record earnings. Orders booked during the quarter exceeded our shipments as we continue to build our extensive order backlog, our current MRidium 3860 infusion pump system was the highest in the last three years,” said Roger Susi.
- Price promotion: IRMD shares trade 1.53% lower at $27.59 on last check Monday.
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