Digital ultrasound company Butterfly Network has achieved EU MDR certification for the Butterfly IQ+ ultrasound system, enabling the company to launch its offerings in the European market, including its AI-based Auto B-Line Counter software and Pulse Wave Doppler (PWD) the company.
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 defined period of time.
Butterfly Network intends to release the features in the second quarter of 2024 and launch its new IQ3 product in Europe later in the year.
The company also produces a portable ultrasound system connected to a smartphone. The third-generation IQ3 ultrasound probe leverages wearable technology to improve frame rates and adds new 3D imaging capabilities.
“EU MDR certification is one of the most difficult regulatory steps for medical device companies entering the European market. We are incredibly proud of this achievement, which highlights our commitment to providing innovative solutions to healthcare professionals around the world. We are grateful for the patience of our existing and future international customers who have been eagerly awaiting these additional imaging tools for improved real-time measurement accuracy,” John Soto, senior vice president, international, said in a statement.
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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 the fourth quarter of 2023, down from $19 million in the fourth quarter of 2022. Adjusted EBITDA loss was $15.7 million, in down from $27.7 million for 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 period of the previous financial year.
The company announcement a reorganization in the second quarter, against a backdrop of a 44% drop in international sales in the first half of 2023. At the time of publication of this article, the Butterfly Network stock was trade at $1.05 per share.
In October, the company in partnership with technology research company Forest Neurotech to develop a whole-brain neural interface that will enable brain imaging and help measure brain function.
EU approval comes after Butterfly received FDA 510(k) Clearance for its Butterfly IQ3 in January, with the product launching for sale in the United States in February. Butterfly received 510(k) clearance for its first generation product in 2020.
Butterfly’s competitors include battery-powered products from GE Healthcare VScan and a Vancouver-based portable ultrasound company Clarius.