PERTH, Australia – The FDA has cleared Immunexpress Inc.’s 510(k) for its Septicyte rapid diagnostic test for sepsis that quantifies the relative expression levels of genes involved in a patient's immune response to infection to aid in a diagnosis in one hour for patients suspected of sepsis. The test uses peripheral blood gene expression biomarkers to provide a probability of sepsis in patients presenting with clinical signs of systemic inflammation. Read More
Restore Medical Ltd. is implanting the first patients with its Contraband technology for congestive heart failure (CHF). The minimally invasive, catheter-delivered implant is being assessed in patients with chronic left ventricular failure. The Or Yehuda, Israel-based startup is carrying out the trial at the ZNA medical center in Antwerp, Belgium, followed by the Kaplan medical center in Israel. The goal of the implant is to enable the right ventricle to strengthen the left ventricle and improve ejection fraction, reduce mitral regurgitation and restore a favorable ventricular geometry. Read More
Wave Neuroscience Inc.’s study of the use of electromagnetic stimulation to treat post-traumatic stress disorder (PTSD) entered its second phase, building on the positive outcomes seen in the phase I collaboration with the U.S. military. Texas A&M University Health Science Center is directing the trial, which will expand the study to civilians. Read More
The emergence of the Omicron variant of the SARS-CoV-2 virus has sparked a vigorous reaction around the globe, which in the U.S. includes steps taken by the Biden administration to ensure that the roughly 100 million people who have received an initial vaccination regime will receive a booster if eligible. The administration also reported Dec. 2 that it will take steps to ensure that home testing will be covered by private payers, all of which amounts to a massive boost in business for manufacturers of vaccines and tests despite concerns about how the Omicron variant might affect vaccine and test performance. Read More
PARIS – Peters Surgical SAS is being sold off. Its majority shareholder, Eurazeo Small-mid buyout, the investment arm for small and medium-sized enterprises at Eurazeo SE, has been preparing Peters Surgical for sale for the last five months. Investment banks DC Advisory and Allinvest are currently engaged in the sale of the company. This round is part of a divestment program at Eurazeo. Interestingly, disposals finalized since the beginning of the year have tripled, reaching $3.5 billion. The Eurazeo group, with a market cap of $6.65 billion on the Euronext Paris stock exchange, is pursuing its ambitious asset disposal program in a buoyant environment. Read More
New hires and promotions in the med-tech industry, including: Bellaseno, Caption Health, Meridian Bioscience, Resolve Biosciences, Sera Prognostics, Statlab Medical Products, Titan Medical. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aditxt Technologies, Aipharma Global Holdings, Becton, Dickinson and Co., Eurofins Scientific, Janssen Research & Development, Nurx, One Mind Psyberguide, Ovia Health, Syndi, Tempus, Venclose. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Active Life Scientific, Amra Medical, Qiagen. Read More
