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Medical Devices › Risk Assessment › Healthcare

Akin Gump Strauss Hauer & Feld LLP

FDA Moves Forward on Fluoropolymers

Akin Gump Strauss Hauer & Feld LLP on

On August 6, 2025, the U.S. Food and Drug Administration (FDA) became the latest governmental agency to confirm that fluoropolymers are both safe and necessary. After an independent safety review of fluoropolymers in medical...more

McDermott Will & Schulte

FDA Reveals AI Development Cheat Sheet in Highly Anticipated Draft Guidances

McDermott Will & Schulte on

Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more

Foley Hoag LLP - Security, Privacy and the...

The Health Sector Cybersecurity Coordination Center’s September 19 Threat Briefing on Healthcare Technology Security

Foley Hoag LLP - Security, Privacy and the... on

As healthcare technology continues to evolve, so does the need for robust compliance strategies to safeguard patient information and ensure the integrity of medical devices. In a joint September 19, 2024 presentation, the...more

Davis Wright Tremaine LLP

Project W: Takeaways From WEB | Health Tech and the Women Transforming Healthcare

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On June 13, in Culver City, twelve founders and over two dozen investors and experts convened for Project W's Women Entrepreneurs Boot Camp | Health Tech to drive innovation that is transforming the delivery of healthcare and...more

Mintz - Health Care Viewpoints

Colorado AI Systems Regulation: What Health Care Deployers and Developers Need to Know

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As the first state law to regulate the results of Artificial Intelligence System (AI System) use, Colorado’s SB24-205, “Concerning Consumer Protections in Interactions with Artificial Intelligence Systems” (the Act), has...more

Mintz - Health Care Viewpoints

State AGs Demand Action on Pulse Oximeter Inaccuracy as FDA's Efforts Lag

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A new battle is emerging in the fight for health equity, and it’s centered on the humble pulse oximeter. On November 1, 2023, 25 state attorneys general sent a letter to the Food and Drug Administration (FDA) demanding that...more

Butler Snow LLP

Cybersecurity: What Businesses Need to Know

Butler Snow LLP on

Cybersecurity is a top concern for all industries, particularly for the pharmaceutical and medical device industries. These industries hold some of the most sensitive data and highly valuable technology, making them prime...more

Butler Snow LLP

Can What the Supreme Court Said About Device Clearance in Lohr, a “Derelict on the Waters of the Law,” Finally Be Sunk?[1]

Butler Snow LLP on

Even though they are still quoted, statements in Medtronic v. Lohr, which question whether FDA (Food & Drug Administration) medical device clearance is a judgment about a device’s safety, no longer accurately describe what...more

Hogan Lovells

FDA Issues Final Guidance on Benefit-Risk Factors to Consider in Medical Device Product Availability, Compliance, and Enforcement...

Hogan Lovells on

On December 27, 2016, the U.S. Food and Drug Administration (FDA) issued a final guidance document entitled "Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement...more

Bergeson & Campbell, P.C.

The Netherlands Publishes Report on Nanotechnologies in Medical Devices

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The Netherlands National Institute for Public Health and the Environment (RIVM) posted on December 17, 2015, a report entitled Nanotechnologies in medical devices. RIVM conducted an investigation to provide insights into and...more

Mintz - Health Care Viewpoints

FDA Proposes to Apply Risk-Based Framework to Accessory Devices

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In another effort to bring some clarity to its regulation of devices, the FDA has released draft guidance on how its risk-based framework applies to accessory devices ( the “Draft Guidance”). This development is welcome...more

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