Artificial intelligence (AI)-based models developed by a team of international researchers were able to identify ovarian cancer in ultrasound images more accurately than humans. Results from a study published in Nature Medicine showed that the AI models achieved an accuracy rate of 86.3%, compared to 82.6% for the experts and 77.7% for the non-expert examiners. Read More
For more than a decade, HIV remained the only sexually transmitted infection (STI) with U.S. FDA approval of at-home sample collection, but a growing number of tests for sexually transmitted infections have received the regulatory greenlight for patients to swab themselves in the privacy of their own homes in recent years. With STIs reaching levels not seen in decades, regulators and physicians hope that the move will increase diagnostic rates and reduce disease spread by overcoming stigma and access barriers. Read More
Makers of digital health apps are not often subject to the provisions of the Health Insurance Portability and Accountability Act (HIPAA), but any such liabilities may soon become more onerous. The Department of Health and Human Services released a draft update for HIPAA cybersecurity mandates – the final version of which is sure to be accompanied by much more vigorous enforcement. Read More
Some people may have seen 2024 as the year of artificial intelligence (AI) in med tech, but the FDA is off to a strong start in 2025 with a dual-purpose AI draft guidance. While the draft covers both premarket submissions and life cycle management considerations, the more important consideration is that the FDA’s centers for devices, drugs and biologics have all signed off on the draft, suggesting an agency-wide convergence in thinking about AI. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Columbia University Irving Medical Center. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Airstrip Technologies, Apyx Medical, Decisio Health, Elutia, Gynesonics, Hologic, Nanovibronix, Predictive Oncology, Renovaro, Spiro Robotics, Vizient, Zero Candida. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic. Read More
