Deep Breeze's vibration-based pulmonary imaging system:
This article was originally published in Clinica
Executive Summary
The US FDA has granted 510(k) marketing clearance for the VRIXP, an imaging system developed by Israeli firm Deep Breeze. The product employs vibration response imaging (VRI) technology, a noninvasive, radiation-free system that uses lung sounds to create dynamic images of the lungs. It records the sounds of the patient's breath, using sensors applied to the back, and then uses an algorithm to convert these data into images. The firm contends that changes in tissue composition or airflow alter the way in which sounds within the lungs vibrate. Or-Akiva-based Deep Breeze plans to launch VRIXP in the US at the 2007 CHEST meeting, to be held in Chicago in October. It received CE mark approval for sale in Europe in September 2005 (see Clinica No 1176, p 19).
You may also be interested in...
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.