In a pivotal milestone for Memed Ltd., the U.S. FDA cleared its Memed BV test on whole blood samples, which will help health care providers distinguish between bacterial and viral infections. The test, which yields results in as little as 15 minutes, can reduce the risk of unnecessary prescriptions which is a key driver of antibiotic resistance. Read More
Twelve years on, Vitalconnect Inc. continues to connect well with investors, raising $30 million in an oversubscribed series F in a still-tight market just 18 months after closing its last $39 million round and less than a year after receiving venture financing from Health Insight Capital, the investment arm of HCA Healthcare Inc. The new funds will support continued growth of the company’s wireless patient monitoring systems, which are used in hospital and home settings. Read More
The U.S. Federal Trade Commission and the Department of Justice have floated a new set of guidelines that would govern their reviews of mergers in a variety of markets, including the drug and device industries. While many of these guidelines are vaguely worded and open to interpretation, one of the more ambiguously worded passages states that a merger may be rejected if it could create “a clog on competition,” a phrase that appears in a Supreme Court decision handed down more than 60 years ago. Read More
Endotheia Inc. reported the successful completion of a first-in-human clinical trial of its steerable technology for endoscopic surgery. The single-use device integrates with standard forward-viewing gastroscopes, allowing physicians to replicate the functions of specialized duodenoscopes that are currently used in the treatment of biliary disease. Read More
Researchers at Harvard Medical School have developed a new tool that promises to improve the way pathologists see and evaluate a tumor, by providing detailed clues about the cancer. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Genedx, Inspira, Monogram Orthopaedics, Perfusion Solution. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Memed. Read More
