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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Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.
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.
Dxcover sets up new Clinical Laboratory Improvement Amendments (CLIA) lab in Franklin, Tennessee.
EnsoData positions itself as device-agnostic and interoperable, with FDA-cleared software that can integrate with all major devices. CEO Mortara said this flexibility helps maximize patient reach by enabling both direct provider engagement and integration with device manufacturers.
After multiple warning letters and safety communications, the US FDA has decided to block the import of certain endoscopes from Olympus. In total, the agency’s action pertains to 58 device models manufactured by the Japanese firm used in urinary, respiratory, abdominal and pelvic procedures.
