New Article Now Available on the Life Sciences Industry Blog - FDA AI/ML SaMD Framework: What Companies Need to Know Now

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Insurance for Life Sciences by Life Sciences Specialists

 

Whether in the United States or abroad, Berkley Life Sciences is solely dedicated to providing premiere insurance coverage for today’s top life sciences companies.

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Who We Insure

We provide personalized property and casualty insurance products and services to the following life sciences markets:

Digital Health Companies

Digital Health Companies

Companies that focus on the convergence of technology and healthcare, developing digital devices, software applications, and online platforms, improving connectivity and spanning a wide range of uses.

Medical Device Companies

Medical Device Companies

Companies that design, manufacture, and distribute medical instruments, digital health products, and devices for healthcare applications. 

Medical Device Software Companies

Medical Device Software Companies

Organizations that develop software solutions for use in union with medical devices and digital health products to enhance functionality and patient outcomes. 

Medical Drug Companies

Medical Drug Companies

Pharmaceutical firms involved in the research, development, manufacturing, and marketing of medications for treating various health conditions.

Biologic Companies

Biologic Companies

Companies that create biologically derived products, including vaccines, blood components, and gene therapies, for medical use.

Dietary Supplement Companies

Dietary Supplement Companies

Firms that produce and distribute vitamins, minerals, and other supplements intended to enhance health and wellness.

Medical Food Companies

Medical Food Companies

Companies that develop and produce foods formulated explicitly for dietary management of diseases or conditions requiring medical supervision.

Cosmetic Drug Companies

Cosmetic Drug Companies

Organizations that create products at the intersection of cosmetics and pharmaceuticals, designed to enhance appearance while providing therapeutic benefits.

Product Development Organizations

Product Development Organizations

Companies offering specialized services in developing, testing, and regulatory approval of life sciences products.

Profit & Nonprofit R&D

Profit & Nonprofit R&D

Entities dedicated to conducting research in life sciences, ranging from private companies to academic and non-profit organizations.

Product Testing Laboratories

Product Testing Laboratories

Laboratories specializing in the testing and validation of life science products, ensuring compliance with regulatory standards and safety requirements.

Medical Product Distributors

Medical Product Distributors

Companies that manage the distribution and supply chain logistics for a wide range of medical products, ensuring their availability to healthcare providers.

Drug Discovery Technology

Drug Discovery Technology

Firms and organizations that develop technologies and methodologies to accelerate the identification and development of new pharmaceutical compounds.

Bioengineering

Bioengineering

Companies and research institutions that apply biology and engineering principles to develop innovative solutions in healthcare, agriculture, and environmental management.

Health Informatics

Health Informatics

Companies that focus on the convergence of technology and healthcare, developing digital devices, software applications, and online platforms, improving connectivity and spanning a wide range of uses.

Non-Medical Biotechnology

Non-Medical Biotechnology

Companies focused on biotechnology applications beyond healthcare, including agriculture, environmental management, and industrial processes.

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The Latest in Life Science

AI/MD SaMD

The FDA AI/ML SaMD Framework: What Companies Need to Know Now

In a recent post on this blog, we examined how artificial intelligence (AI) and machine learning (ML) are reshaping the informed consent process in clinical trials—and why the regulatory and legal frameworks surrounding AI in that context are still catching up. That article focused on one corner of the clinical trial lifecycle. This one broadens the lens. Medical devices, and in particular software as a medical device (SaMD) is a different but related category.

Clinical Trials and Informed Consent: An Emerging Role for Artificial Intelligence?

Clinical Trials and Informed Consent: An Emerging Role for Artificial Intelligence?

In a recent episode of HBO Max’s The Pitt, an emergency-room attending physician shows medical students the time savings that can come from using a generative artificial intelligence (AI) tool to listen to a doctor–patient conversation and populate a medical record in seconds. But the same storyline highlights the downside: the tool invents details, confuses medications, and even swaps “neurology” for “urology”—mistakes that could put a patient at risk.

GLP-1s: Litigation, Enforcement, and Marketing Watchpoints

GLP-1s: Litigation, Enforcement, and Marketing Watchpoints

Previously on the blog, we focused on the regulatory and compliance risks surrounding compounded GLP‑1 products, particularly misbranding, quality concerns, and how quickly the enforcement landscape has evolved. Continuing this discussion, we broaden the lens to the developing litigation environment and additional regulatory scrutiny that can affect manufacturers, pharmacies, telehealth providers, and other stakeholders across the GLP‑1 ecosystem.

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