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.
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.
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.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Baird Medical, Reddyport.
Recalls are a fact of life in the medical technology space, and Medtronic plc and Quidel Cardiovascular Inc., have both been forced to report class I recalls. Dublin-based Medtronic announced a recall of more than 348,000 cardiac electrophysiology devices due to issues that could prevent high-voltage therapy while San Diego-based Quidel is recalling nearly 7,800 Triage cardiac panels because of a risk of false negatives for patients being assessed for an infarct.
Responding to medical advances and new standards of care in Alzheimer’s, the U.S. Centers for Medicare & Medicaid Services (CMS) is proposing to end its 10-year-old coverage with evidence development policy that has limited Medicare reimbursement of amyloid PET scans to once in a lifetime for beneficiaries – and then only when they’re used in a CMS-approved trial.
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