9 tips for implementing AI in medical devices from a Medtronic executive

Patients and healthcare providers remain at the core of successful AI implementations in medtech. [piai/Adobe Stock]

It seems like artificial intelligence (AI) is ubiquitous in the healthcare landscape, but the technology remains nascent in the industry. Technologies ranging from machine learning to natural language processing and beyond promise to help make diagnoses and treatment more precise, efficient, and personalized.

But the allure of AI can sometimes overshadow the central goal of addressing tangible clinical problems.

During his talk at DeviceTalks West, Ha Hong, chief AI officer at Medtronic Endoscopy, underscored the importance of putting patients and healthcare providers at the forefront when incorporating AI into medical devices.

With a plethora of AI tools at our disposal — many of which are increasingly user-friendly — the onus is on us to wield them responsibly. Below, you’ll find …

Read more
  • October 26, 2023
  • 0

FDA releases guidance on pharmaceutical supply chain security

[Corona Borealis/Adobe Stock]

The FDA recently published guidance to help the pharma industry detect suspicious and illegitimate products within the pharmaceutical supply chain. These regulations, established under the Drug Supply Chain Security Act (DSCSA), concentrate on product tracing, verification, and identification for specific drug products distributed in the U.S.

So far this year, the agency has released more than a dozen guidance documents related to the development of new drugs, the use of pharmacogenomic data in drug submissions, quality considerations for cannabis-derived compounds and clinical trials for drug and biologics.

Here, we summarize the guidance on suspicious and illegitimate products, clarifying the interpretation of terms such as counterfeit, diverted, stolen, fraudulent transaction and unfit for distribution, as defined in section 581 of the FD&C Act (21 U.S.C. 360eee). Read more

  • March 18, 2023
  • 0