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What to Know about IEC 62304 and Why It’s Important for SaMD

Dot Compliance

Digital transformation has ignited a change in the medical device industry, one that leverages technology to create life-saving devices. Not just as a component of a medical device but as the medical device itself. This clear distinction is what’s known as Software as a Medical Device (SaMD).

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7 Things to Know About the New AdvaMed Code Updates

Healthcare Law Blog

On March 18, 2022, AdvaMed announced updates to the Code of Ethics on Interactions with Health Care Professionals (“Code”), a voluntary code that provides medical technology companies with guidance on ethically compliant interactions and relationships with healthcare professionals. The changes will take effect on June 30, 2022.

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Innovative AM Strategies for Fast-Tracking a Device’s Path to Market

HIT Consultant

For a successful AM implementation, it’s important to fully understand the goals for the new implant and/or instrument, and what the right solution will be to produce the device most effectively. Let’s explore more about what to expect: 1. The industry-accepted average is 20 months.

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Medical Devices Cleared or Approved by FDA in 2022

HIT Consultant

The medical device industry is booming and shows no signs of slowing down. In 2022, the FDA ( Federal Food and Drug Administration ) will clear or approve over 1,000 medical devices. The AccelStim Bone Growth Stimulator is a device that uses low-intensity pulsed electromagnetic fields to stimulate bone growth.

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Concerning Health IT Trends: What Can We Do and What Happens if We Do Nothing?

Healthcare IT Today

While everyone seems to be excited about it, you might be left with questions and concerns about what its impact will be. What can be done about it and what’s the impact if we do nothing? Properly educating the market so that healthcare stakeholders can be more discerning about the 2. Who owns the data?”

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Engage Venture Partners Announces Lead Investment in VOCxi Health

Healthcare IT Today

To learn more about Engage and investment opportunities, email investors@engagevp.com. About Engage Venture Partners. Minneapolis-based and Woman-Owned, Engage Venture Partners is a research-driven venture capital firm focused on early-stage medtech investments.

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Financial Experience: Empowering Patients to Improve Affordability

HIT Consultant

He brings more than a decade of experience in the medical device industry to the company. After serving as the primary caretaker for several family members following a cancer diagnosis, Srulik started TailorMed with a personal mission to leverage technology to tackle the financial challenges of care delivery.