Ultromics Ltd. secured a strategic investment from the American Heart Association's Go Red for Women Venture Fund to advance the use of its technology to help clinicians better identify women suffering from heart failure with preserved ejection fraction (HFpEF). The condition goes undiagnosed in millions of women, who are disproportionately affected by HFpEF. Ultromics’ Echogo Heart Failure software analyzes routine ultrasound scans to quantify heart function and identify patterns that signal HFpEF. Read More
The FDA’s final guidance for the use of real-world evidence (RWE) was touted by FDA commissioner Marty Makary as opening the door to the use of existing de-identified data in premarket device submissions, but the final guidance lends also clarifies a couple of points about when an investigational device exemption will be needed for RWE studies. Read More
Med-tech M&A value in 2025 totaled about $38.99 billion through November, reflecting a clear slowdown from 2024’s $57.92 billion and well below the peak years of 2021 and 2022, when 11-month totals exceeded $119 billion and $132 billion, respectively. Activity this year has been uneven, with a strong April ($9.04 billion) and July ($7.29 billion) accounting for a large share of the total, while several months posted relatively modest figures. November was particularly quiet, delivering just $5 million in M&A value, down sharply from $1.68 billion in October and marking the weakest month of the year. Read More
Advances in antiretroviral therapy (ART) now allow people living with HIV to lead normal lives with undetectable and nontransmissible levels of the virus in their blood. Yet that reality is limited to those with access to treatment. More than 40 million people worldwide live with HIV, with over a million new infections and hundreds of thousands of deaths each year, underscoring that major challenges remain. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Craniosense, Hardy Diagnostics, Pulse Biosciences. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Cutera, Enable Injections, Femasys, J&J. Read More
