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Mintz - Health Care Viewpoints

FDA Needs a New Approach to AI/ML-Enabled Medical Devices

Mintz - Health Care Viewpoints on

We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital technology, such as launching the...more

Mintz - Health Care Viewpoints

Things to Consider When Determining the Regulatory Requirements for Software (Hint: It’s More Than the Device Classification)

Mintz - Health Care Viewpoints on

The capabilities and sophistication of digital health technologies are constantly expanding, especially with the integration of artificial intelligence and machine learning. Many companies, both existing and start-up, are...more

Hogan Lovells

Reforms to software-based medical devices take effect this week

Hogan Lovells on

The new classification rules for software-based medical devices (“SaMDs”) and personalised medical devices introduced by the Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 commences this week,...more

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