Digital ultrasound company Butterfly Network has achieved EU MDR certification for the Butterfly IQ+ ultrasound system, allowing the company to release its offerings into the European market, including its AI-enabled software Auto B-Line Counter and the company’s Pulse Wave Doppler (PWD). 

Auto B line Counter uses AI to help providers determine patient abnormalities by measuring B-lines. B-lines appear as bright lines on an ultrasound and are associated with conditions such as chronic obstructive pulmonary disease (COPD). 

Pulsed Wave Doppler, which received FDA clearance last year, is a mode that providers can use to graphically display blood flow velocity measurements over a set span of time.

Butterfly Network intends to release the features for sale in the second quarter of 2024 and launch its new IQ3 product in Europe later in the year. 

The company also produces a handheld, smartphone-connected ultrasound system. The third-generation IQ3 ultrasound probe builds on the handheld technology to enhance frame rates, and adds new 3D-imaging capabilities. 

"EU MDR certification is one of the most challenging regulatory milestones for medical device companies entering the EU Market. We are incredibly proud of this achievement, which underscores our commitment to providing innovative solutions to healthcare professionals worldwide. We are grateful for the patience of our existing and future international customers who have been eagerly awaiting these additional imaging tools for enhanced real-time measurement accuracy," John Soto, senior vice president for international, said in a statement.

THE LARGER TREND

The Massachusetts-based company received FDA 510(K) clearance for its AI-enabled lung function tool in early 2023. 

Butterfly Network reported total revenue of $16.5 million in Q4 2023, down from $19 million in Q4 of 2022. Adjusted EBITDA loss was $15.7 million, down from $27.7 million in the same period in 2022. Gross loss was $9.4 million for the fourth quarter, compared to gross profit of $9.6 million in the prior year period. 

The company announced a reorganization in Q2, amid a 44% decrease in international sales in the first half of 2023. At the time this article was published, Butterfly Network stock was trading at $1.05 per share. 

In October, the company partnered with tech-enabled research company Forest Neurotech to develop a whole brain neural interface that will allow brain imaging and will help measure brain function.

The EU approval comes after Butterfly received FDA 510(k) clearance for its Butterfly IQ3 in January, with the product being launched for sale in the U.S. in February. Butterfly received 510(k) clearance for its first-generation product in 2020. 

Butterfly competitors include GE Healthcare’s battery-powered VScan and Vancouver-based handheld ultrasound company Clarius.