Challenges scheduling time for a mammogram, frustration waiting for the exam itself and pain from the test have caused any number of women to cry. Namida Lab Inc. may take the inconvenience and anxiety out of breast health assessment with its Auria test, but the tears will stay. Like a growing number of assays, the test uses tear-based analytics to determine cancer risk. Read More

Medical device manufacturers have railed against payers’ prior authorization practices for years, but the U.S. Congress seems poised to finally address the issue, at least in the context of Medicare Advantage (MA) plans. The House of Representatives has passed the Improving Seniors’ Timely Access to Care Act of 2021, a development that drew the applause of both the Medical Device Manufacturers Association (MDMA) and the American Society of Radiation Oncology (ASTRO), a clear display of the broad support enjoyed by the legislation. Read More

Verici Dx plc reported positive results in the initial validation of its pre-transplant blood test for predicting the risk of early acute kidney rejection. Read More

While 2022 represents the lowest financing year for med-tech companies over the past four years, amounts raised through IPOs, venture capital rounds and private placements are still topping other years, while stagnant follow-on activity weighs heavily on the overall total. Read More

The Biden administration’s views of mergers and acquisitions have veered sharply from those of the previous administration, but Jonathan Kanter, assistant U.S. attorney general, said recently that there is more to come. Kanter said the Department of Justice (DOJ) and the Federal Trade Commission (FTC) will shortly publish draft guidelines that would place the burden on the parties to these M&A transactions to prove the transaction is not anticompetitive, upending the historical presumption that the plaintiff is liable for demonstrating the anticompetitive nature of the proposed transaction. Read More

With the science on aging advancing, it’s time for the U.S. to modernize its regulatory approval path for new longevity treatments, members of a House Science, Space and Technology subcommittee were told Sept. 15. Read More

New hires and promotions in the med-tech industry, including: Caris Life Sciences, Diality, Immunologix, Livanova, Protembis, Raysearch, Tilak. Read More

Med-tech firms raising money in public or private financings, including: Aignostics, Excision Medical, Tricares. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cloudmd. Read More

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Neovasc, Qiagen, Theragen, Tytocare. Read More

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BVI, CTL Amedica, Edwards Lifesciences, Konica Minolta. Read More