Insulet Lawsuit Alleges EOFlow Stole Diabetes Tech

The complaint says that EOFlow developed its EOPatch insulin delivery system with the help of former Insulet employees and Insulet’s contract manufacturer. Medtronic announced plans to acquire EOFlow in May, and US FDA clearance is on the horizon.

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Democrats Condemn Trump’s HHS Layoffs During House Hearing On OTC Drug User Fees

 

Energy and Commerce Health Subcommittee Democrats focus on criticizing HHS Secretary Kennedy’s RIF announcement, including 3,500 FDA jobs among cuts across HHS agencies. Representatives were left wondering if user fee programs would continue, even if reauthorized.

LDT Saga Comes To A Grinding Halt As Judge Sides With Labs, Vacates FDA’s Final Rule

 

A federal judge in Texas delivered what is most likely a fatal blow to the US FDA’s final rule, which would have regulated lab-developed tests as medical devices.

US Federal Trade Commission Challenges Surmodics-Biocoat Merger Over Antitrust Concerns

 
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A planned merger between medical device coating manufacturers Surmodics and Biocoat is facing an antitrust lawsuit from the US Federal Trade Commission. The FTC believes the move would create an illegal monopoly.

Court Decision On LDTs ‘Quite Realistic’ Before May Deadline, Says ACLA Attorney

 

An attorney representing the ACLA in its lawsuit to stop the US FDA’s final rule on LDTs emerged from a lengthy hearing on the case feeling ‘cautiously optimistic’ and said a decision could come before May.

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Global Medtech Guidance Tracker: March 2025

 
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

Whitaker Wants Congress To Capitalize On ‘Golden Age Of Medical Innovation’

AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.

First At-Home Test For Multiple STIs Gets FDA Clearance

 
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The Visby Medical Women’s Sexual Health Test is the first over-the-counter test cleared by the US Food and Drug Administration to detect chlamydia, gonorrhea and trichomoniasis. It delivers results in about 30 minutes.