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February 5, 2026

The Latest on the Medical Device Industry

Planning for FDA Shutdowns Now and in the Future—Mike on Medtech

Mike Drues and Sean Fenske discuss the government shutdown, FDA impact, and what medical device manufacturers should be doing during this time.
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Today's Top Headlines

OEM News

Olympus Shares Positive Study Results for its CADDIE AI Solution

The CADDIE application was associated in the study with a 7.3% absolute increase in adenoma detection rate.

Regulatory

Medtronic Diabetes Announces FDA Clearances, MiniMed Medicare Access

Medicare and Medicare Advantage beneficiaries can now access the MiniMed 780G system with the Instinct sensor.

People

ZOLL Medical Names New CEO

Eric Knudsen will move into the corner office on April 1.

Regulatory

FDA Clears AI-Powered Lung Nodule Risk Assessment Tool

RevealAI-Lung secured MDR Certification in November.

OEM News

Lubrizol Unveils New Implantable Medical-Grade Material

TOLERATHANE TPU’s performance attributes closely align with the technical requirements of neuromodulation and cardiac leads.

Regulatory

FDA Approves Hologic’s Aptima HPV Assay Primary Screening Option

Expanded FDA approval across multiple cervical cancer screening modalities supports clinical flexibility and provider choice.

Emerging Markets

25 Years in Costa Rica: Medtech Manufacturing Lessons Learned

If I had to summarize Costa Rica manufacturing in one sentence, it would be this: "The opportunity is real, but it is not a shortcut."