digital ultrasound testing company butterfly network has received EU MDR certification for its Butterfly IQ+ ultrasound system, allowing it to release products such as the AI-enabled software Auto B-Line Counter and its Pulsed Wave Doppler (PWD) to the European market.
Auto B line Counter uses AI to help healthcare professionals determine abnormalities in patients by measuring B lines. B lines appear as bright lines on ultrasound and are associated with conditions such as chronic obstructive pulmonary disease (COPD).
Received pulsed wave Doppler FDA approval This is a mode that providers can use to graphically display blood velocity measurements over a set period of time.
Butterfly Network plans to release features for sale in the second quarter of 2024 and launch the new IQ3 product in Europe later that year.
The company also makes handheld ultrasound systems that connect to smartphones. The 3rd generation IQ3 ultrasound probe is based on handheld technology with increased 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 extremely proud of this achievement, which supports our commitment to providing innovative solutions to healthcare professionals around the world. We appreciate the patience of our existing and future international customers as they look forward to these additional imaging tools to improve real-time measurement accuracy,“ John Soto, senior vice president of international, said in a statement. .
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A company based in Massachusetts received Receives FDA 510(K) clearance for AI-enabled pulmonary function tool in early 2023.
butterfly network report Total revenue for the fourth quarter of 2023 was $16.5 million, down from $19.0 million in the fourth quarter of 2022. Adjusted EBITDA loss was $15.7 million, down from $27.7 million in the same period in 2022. Gross profit for the fourth quarter was $9.4 million. The same period last year was $9.6 million.
company announced Restructuring is planned for the second quarter amid a 44% decline in international sales in the first half of 2023.At the time this article was published, Butterfly Network's stock price was transaction $1.05 per share.
In October, the company partnered In collaboration with technology research firm Forest Neurotech, we have developed a whole-brain neural interface that enables brain imaging and helps measure brain function.
EU approval means that Butterfly FDA 510(k) clearance Butterfly IQ3 was announced in January and the product will be available in the US in February. Butterfly received his 510(k) clearance for his first generation product in 2020.
Butterfly's competitors include battery-powered products from GE Healthcare. VS scan Vancouver-based handheld ultrasound company Clarius.