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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Jan. 6, 2025

View Archived Issues
Illustration of a cluster of ovarian cancer cells

New AI-based models better than humans at diagnosing ovarian cancer

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
Transmission electron micrograph of HIV particles

As STIs explode, at-home testing reduces diagnostic barriers

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

HHS floats much more stringent set of HIPAA security measures

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
AI biotech research concept with lightbulb and digital background

FDA inks draft guidance for AI applicable across product centers

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year of artificial intelligence (AI) in med tech, but the FDA is off to a strong start in 2025 with a dual-purpose AI draft guidance.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

Med-tech gainers and losers for Dec. 30, 2024 - Jan. 3, 2025

The top 10 med-tech stock gainers and losers for the week. Read More

Appointments and advancements for January 6, 2025

New hires and promotions in the med-tech industry, including: Eyenuk, Livanova, Lumicell, Perspective Therapeutics. Read More

Financings for January 6, 2025

Med-tech firms raising money in public or private financings, including: Bionano Genomics, Microbot Medical, Outset Medical, Quantum-Si. Read More

In the clinic for January 6, 2025

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Columbia University Irving Medical Center. Read More

Other news to note for January 6, 2025

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 actions for January 6, 2025

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic. Read More

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