Follow us on:
Breaking News
February 5, 2026
The Latest on the Medical Device Industry
Breaking News
MPO Summit 2026_Early Bird_Leaderboard_0926

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

 
Mike on Medtech podcast

Mike Drues and Sean Fenske discuss the government shutdown, FDA impact, and what medical device manufacturers should be doing during this time.
Play Now >>

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.

SPONSOR

Offering Services to Address Concept to Care—A Medtech Makers Q&A

Anchored by a company name change, a CDMO provides insights on the importance of ensuring an organization’s offerings align with the needs of the industry.

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.

SPONSOR

PTI Engineered Plastics Inc.

PTI is a single source injection molding contract manufacturer specializing in low to medium volume plastic injection molding for the Medical, Defense and Consumer Product industries.

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."

Featured Resources

Solution Center SPOTLIGHT

SigmaTron International

SigmaTron International is a full service EMS provider with a network of manufacturing facilities in the United States, Mexico, China and Vietnam that enables us to provide a wide range of onshore, nearshore and offshore manufacturing options. We focus on companies who want highly customized service plus a scalable global manufacturing footprint. Our International Purchasing Office (IPO) in Taiwan combined with experienced procurement professionals at each facility ensures a highly competitive materials management strategy. Our quality certifications include ISO 9001, ISO 13485, IATF 16949 and a California FDB Device Manufacturing License.