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....
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Medtech Insight for daily insights
Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, content format or the method in which you receive and access Medtech Insight, or if you love it how it is, now is the time to have your voice heard.
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.
While HistoSonics is awaiting the CE mark in Europe, it hit a major milestone by securing early limited market access in Great Britain under a Unmet Clinical Need Authorization (UCNA), bringing its noninvasive histotripsy treatment to patients with liver tumors.
Manufacturing shifts, financial planning, and supply chain changes are among the adjustments that medtech leaders are making to Trump-era tariffs. Medtech Insight’s review of first-quarter earnings calls reveals how firms are navigating the impact and uncertainty of evolving trade policies.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.