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WHAT WE'RE SEEING - In this Life Sciences & Healthtech edition of The Download, we take on key trends at the intersection of tech and healthcare, continuing the energizing conversation from JPM Healthcare last week. 01 A...more
On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” which...more
On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more
Last week, the U.S. Food and Drug Administration (FDA) finalized guidance on the types of information that should be included in a Predetermined Change Control Plan (PCCP) as part of a marketing submission for an artificial...more
On December 4, 2024, the U.S. Food and Drug Administration (“FDA”) released its final guidance for industry on predetermined change control plans (“PCCPs”) for devices that utilize artificial intelligence-enabled software...more
For decades, FDA’s Center for Devices and Radiological Health (CDRH) has been recognizing standards that can be referenced in premarket medical device submissions....more
Investment in artificial intelligence (AI) is rising fast. The International Data Corporation projects global spending on AI R&D will reach $632 billion by 2028, more than twice the expected total for 2024....more
Even before the Biden administration issued a landmark executive order on October 30, 2023, establishing new standards for artificial intelligence (AI) safety and security, the US Food and Drug Administration (FDA) had been...more
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
Artificial intelligence promises to transform the way we live and work and its impact will undoubtedly stretch to every business sector across the globe. This next generation of technology brings exciting possibilities and...more
Introduction - Hardly a day goes by when we don’t see some media report of health care providers experimenting with machine learning, and more recently with generative AI, in the context of patient care. The allure is...more
If there is one thing that everyone can agree on, it is that health is an important factor in life. In 2021, over 3 million people died in the United States with heart disease and cancer topping the list....more
FDA is actively monitoring the use of AI and machine learning (ML) software in medical devices and clinical developments, and has taken a number of first steps in building out a regulatory framework. In 2021, FDA published...more
What This Means for the FDA and the Industry - The COVID-19 pandemic has spurred the development of digital health products utilizing artificial intelligence (AI) and machine learning (ML). When the pandemic passes, there...more
The applications of artificial intelligence (AI) are seemingly innumerable with benefits reportedly as prolific as the technology behind them, including in the healthcare space. To keep pace, the US Food and Drug...more
The Food and Drug Administration’s recent discussion paper suggests a new regulatory approach for evaluating postmarket changes to artificial intelligence and machine learning software devices, but further clarity is needed...more