Baraban Securities is underwriting a proposed initial public offering of 1.5 mil. U.S. Drug Testing shares at an expected price of $5 per share, according to a preliminary prospectus filed with the Securities and Exchange Commission Aug. 10. Founded in 1992, U.S. Drug Testing has received FDA 510(k) clearance to sell its flow immunoassay system model 9000 drug detection system along with assays for cocaine and opiates. The Rancho Cucamonga, California firm currently is pursuing 510(k)s for three additional assays: PCP, amphetamines and marijuana. "The company's initial product line will screen for the presence of drugs of abuse in urine samples," the prospectus says. "The company expects to initiate development of an additional product line that will utilize saliva as the medium for drug detection." U.S. Drug's flow immunosensor technology is licensed from the U.S. Navy. Once the whole line of assays has been cleared by FDA, the company plans to seek distributors. U.S. Drug Testing President Douglas Allan is a former vice president of Alcon Surgical Systems....
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In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.
The medtech M&A landscape is experiencing a resurgence fueled by significant capital from private equity and venture firms, says Alex Wakefield, CRO of AcuityMD. Building strong relationships with physicians remains crucial in medtech, and defining an exit strategy early is imperative.
