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March 19, 2026
THE LATEST ON THE MEDICAL DEVICE INDUSTRY
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Pharma & MedTech_MPO_Leaderboard_0326

Regulatory Compliance: What’s ‘Good Enough’ for Early Clinical Studies?

 
Regulatory Compliance: What’s ‘Good Enough’ for Early Clinical Studies?

When you’re in the middle of development for a medical device, and the first clinical studies are on the horizon, compliance might seem a rather daunting prospect.
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Today's Top Headlines

OEM News

MiniMed Flex Smartphone-Controlled Insulin Pump Wins FDA Nod

The MiniMed Flex pump is about half the size of the MiniMed 780 and about the size of two stacked insulin vials.

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Evolving Assembly, Packaging, and Sterilization Decisions—A Medtech Makers Q&A

While many considerations are factored into early product development, later stages must also be included alongside them to ensure a smooth path to commercialization.

OEM News

LivaNova Earns FDA Approval for Neurostim for Sleep Apnea

The system employs proximal hypoglossal neurostim to treat patients with moderate to severe obstructive sleep apnea.

OEM News

FDA Approves JenaValve’s Trilogy Transcatheter Heart Valve System

Trilogy THV is the first and only transcatheter device in the U.S. with a dedicated indication for eligible patients.

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BMP Medical

Provides plastic contract manufacturing services to leading medical device & diagnostic OEMs in need of injection molding, and injection blow molding contract manufacturing services.

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OEM News

Imperative Care Nets $100M for Stroke Care, Robotic Tech

The company also appointed Evan Melrose, MD, CEO of Elevage Medical Technologies, to its board of directors.

OEM News

FDA OKs Perfuze’s Millipede88 Aspiration Catheter

Millipede88’s corrugated structure is designed to simplify navigation through tortuous neurovascular anatomy.

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MPO Summit 2026

Enjoy an Early Bird Discount for Medtech’s Premier Conference, taking place October 7–8, 2026 at the Grand America Hotel in Salt Lake City, UT.

People

Scientists Create Self-Deploying, 4D Printed Vascular Stent

The stent expands naturally at body temperature, eliminating the need for external heating.

Features

Staying in Target Range with Diabetes Technologies

Continuous glucose monitors, smart insulin pumps, and integrated digital health tools are transforming diabetes management.

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Featured Resources

Solution Content Center SPOTLIGHT

PTI Engineered Plastics Inc.

PTI is a custom injection molder and manufacturer of plastic components and assemblies. Capabilities include design, engineering, tooling, low and high volume production, and an array of secondary services. ISO Class 8 Cleanroom services include molding, assembly and packaging. PTI is ISO 13485 and MedAccred AC8160 certified and offers validation services.