Narvik (Norway) August 17, 2017. Biim Ultrasound announced August 17th that they made a 510(k) regulatory submission to the U. S. Food and Drug Administration (FDA) for its Biim™ Linear probe and Biim™ software App.
If the 510(k) application is cleared by the FDA it is expected that the Biim™ linear probe and Biim™ software App. will be used for diagnostic ultrasound imaging and/or fluid flow analysis of the human body.
Rune Nystad, CEO and founder of Biim Ultrasound AS stated, “This is a significant achievement for the company and we are very excited about the filing. The filing is based on years of product development and market verification for this unique wireless disruptive ultrasound concept. We have put together a strong submission and are hopeful for a positive outcome in the final quarter of 2017. The submission is a global team effort including resources from Norway, Finland & the United States. It represents an important milestone for the company,” continued Nystad.
Biim Ultrasound was founded in 2011 with the vision of making high quality, affordable point-of-care ultrasound imaging available to a broad range of trained medical professionals. The company is committed to improving patient care and reducing healthcare costs by enabling faster and easier diagnostic ultrasound imaging.
The company is headquartered in Narvik, Norway.
For more information, contact
Rune Nystad, Founder/ CEO Biim Ultrasound, firstname.lastname@example.org/ + 47 91 62 46 83