07/09/2026
❗ Neola Medical Receives FDA Breakthrough Device Designation- a major company milestone
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Neola®, the Company’s medical device for non-invasive, continuous lung monitoring in preterm born babies, with the intended use to support timely detection of potentially life-threatening lung collapse.
The designation represents a significant regulatory and strategic milestone for Neola Medical and its U.S. regulatory pathway. Through the Breakthrough Devices Program, Neola Medical gains the opportunity for more frequent and interactive communication with the FDA, as well as prioritized review of regulatory submissions.
“This is an important recognition of the potential of Neola® to address a critical unmet need in neonatal intensive care,” says Hanna Sjöström, CEO of Neola Medical. “Receiving Breakthrough Device Designation from the FDA is a major milestone for Neola Medical and strengthens our U.S. regulatory pathway. It gives us the opportunity for a more direct and prioritized dialogue with the FDA, which may support a more efficient regulatory process and accelerate our route to market. Our objective is to bring Neola® one step closer to the preterm born babies who benefit from earlier detection of life-threatening lung collapse.”
The FDA Breakthrough Device Designation supports Neola Medical’s focus on high-value clinical use cases where continuous lung monitoring may provide meaningful clinical benefit, particularly in the detection of life-threatening lung collapse (pneumothorax), a severe pulmonary complication. The Company will now continue its regulatory and clinical preparations in the United States, including further dialogue with the FDA regarding the evidence required to support future market authorization.
