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November 8, 2024

Guilford-based Hyperfine gains approval to sell portable imaging device in Europe

Contributed Hyperfine's portable MRI unit, Swoop.
By David Krechevsky

Hyperfine Inc., a Guilford-based biotechnology firm, said Thursday it has received approval to market Swoop, its portable imaging device, in the European Union.

Hyperfine makes a compact, portable MRI (magnetic resonance imaging) unit that is more convenient and less expensive than traditional machines. Approved by the Food & Drug Administration (FDA), the unit can be rolled up to a patient’s bedside and plugged into a standard wall outlet. 

According to the company, it can help medical providers make a rapid diagnosis, such as whether a patient has had a stroke, helping to save lives.

Swoop received what is known as CE approval (an acronym for the French “Conformite Europeenne”), which the company said is a significant step in positioning Hyperfine for broad European launch of the unit.

According to the International Trade Administration, the CE marking “certifies that a product has met EU health, safety, and environmental requirements, which ensure consumer safety.”

Hyperfine Chief Commercial Officer David Castiglioni said the company already has a “broad international distribution network” in place. 

“We are well positioned for commercial expansion,” he said. “We look forward to expanding our collaboration with European healthcare leaders and providers to improve brain MRI access and patient outcomes across the region.”

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