Illumina faces $478M fine over Grail deal, FDA updates guidance on paclitaxel-coated devices

13/07/2023 10 min
Illumina faces $478M fine over Grail deal, FDA updates guidance on paclitaxel-coated devices

Listen "Illumina faces $478M fine over Grail deal, FDA updates guidance on paclitaxel-coated devices"

Episode Synopsis

Olympus this week announced positive study data for its minimally invasive iTind treatment for enlarged prostate symptoms. Fast Five hosts Sean Whooley and Danielle Kirsh go over what that treatment option is, how it works and what some of the study results showed. 

Eitan Medical's launch of a cloud-based infusion management platform reflects the integration of digital technologies into healthcare, aiming to enhance patient safety and optimize medication administration. Learn more about what Eitan Insights is and what the company designed the technology for in today's episode. 

Urotronic designed Optilume as a minimally invasive surgical therapy to alleviate urinary symptoms caused by BPH – and the FDA approved its use this week. Whooley explains what the technology does and how optimistic executives are after news of the approval. 

FDA's updated guidance on paclitaxel-coated devices provides important insights into the ongoing evaluation and monitoring of device safety. Hear about why it updated the guidance and the recommendations for provider action with the new guidance. 

The EU's significant fine imposed on Illumina over the Grail deal highlights the increasing scrutiny and regulation within the medtech industry, particularly regarding mergers and acquisitions. Whooley and Kirsh discuss why the fine was issued, as well as a brief history of the acquisition and what Illumina plans to do next.

Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.

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