Successful Development, Approval and Deployment
of Digital Health Solutions

By Jennifer Geetter, McDermott Will & Emery LLP

For life sciences companies seeking to develop, deploy and successfully commercialize digital health products and solutions, the pathway to success can have many twists, turns and roadblocks. This article examines some of the major challenges to bringing digital health products to market and explores potential opportunities to ease the journey.

Revolutionizing Healthcare:
Augmented Reality's Unprecedented Impact

By David Goldman, Lumus

Augmented reality (AR), with the help of artificial intelligence (AI), is providing healthcare professionals with the means to offer patients an unprecedented level of care and personalized treatments, and assisting MedTech and life sciences companies in product design and development. Yet, the potential of AR with AI in health care is still far from fully explored.

MedTech Marketing Pearls for FDA Clearance and Beyond

By Amanda Bloom, Radiaction Medical

As VP of Product Marketing for a MedTech startup, my role is to champion pioneering medical technology, strategically spark interest and drive it out of the design lab and into the field where it will ultimately change, or even save lives. Over the last two decades, I’ve seen the industry evolve in interesting ways, and I’ve learned some enduring lessons about market introduction and launch of market-making technologies post-FDA clearance.

• Engage with MedTech executives and regulators in Washington DC for an in-depth look at trends in advanced manufacturing and supply chain intelligence.
• Trends in Advance Manufacturing Technology for quality improvement & management, speeding time to market, mitigating labor resource issues, and more.
• Supply Chain Intelligence technologies and strategies for building sustainable, resilient supply chains.

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FDA Updates Guidance on ISO 10993-1 for Evaluation of Biocompatibility

By MedTech Intelligence Staff

The FDA has updated its guidance, Use of International Standard ISO 10993-1, “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process,” to provide further clarification and updated information on the use of International Standard ISO 10993-1, “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process” in pre-market applications.

Featured Quote

While these cases and the Court’s invalidating of Amgen’s patent claims seem an admonition against broad claiming in patents, the Amgen opinion offers solace.

— Philip L. Hirschhorn and Travis W. Bliss, Ph.D.,, Panitch Schwarze Belisario & Nadel LLP

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