Medical Innovation Exchange

regulatory compliance

Registration Opens for March IMDRF Meeting in Washington, DC

Registration Opens for March IMDRF Meeting in Washington, DC     Industry members and other stakeholders are invited to register for the 25th session of the International Medical Device Regulators Forum (IMDRF). The FDA, as the Chair and Secretariat of IMDRF, will be hosting this year’s session at the Ronald Reagan Building & International Trade Center …

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DiMe Convenes Industry Leaders to Streamline Commercialization of Digital Health Products

DiMe Convenes Industry Leaders to Streamline Commercialization of Digital Health Products     The Digital Medicine Society (DiMe) has announced that it is partnering with Peterson Health Technology Institute (PHTI), ZS Associates and other leading industry organizations to define how Integrated Evidence Plans (IEP) can be developed, optimized and used to support the regulatory and commercial success of digital health products (DHPs) on …

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Call for Abstracts: MedTech Regulatory Management Summit

Call for Abstracts: MedTech Regulatory Management Summit     The call for abstracts for the 2024 MedTech Regulatory Management Summit, hosted by Medtech Intelligence, is now open. The Summit, which will be held June 3-5, 2024, in Washington, DC, offers education, discussion and networking for the Medtech community as it works to develop processes, procedures and …

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How to Thrive Amid the Shifting Sands of Medical Device Regulations

How to Thrive Amid the Shifting Sands of Medical Device Regulations     Emerging issues around artificial intelligence (AI), telehealth and data privacy have triggered a surge in regulatory action. This trend is both a challenge and an opportunity. Companies that can adapt quickly to meet regulatory shifts could surge ahead of the competition. Here’s how …

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Navigating Global Regulations for SaMD

Navigating Global Regulations for SaMD     As patients increasingly seek tailored medical care that aligns with their unique needs and preferences, digital-first software resources such as Software as a Medical Device (SaMD) have become the need of the hour. SaMD solutions collect and analyze individual patient data, equipping clinicians and patients with personalized insights. A …

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Companion Diagnostics Regulations are Evolving in Asia

Companion Diagnostics Regulations are Evolving in Asia     Personalized medicine is experiencing a global surge in popularity, with Companion Diagnostics (CDx) products playing a pivotal role in facilitating this expansion. While CDx products are being used frequently in the West for personalized medicine, in the future, providers in Asia will also use more CDx products …

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Unlocking Success in SaMD Product Launches Through AI

Unlocking Success in SaMD Product Launches Through AI     The field of digital health is rapidly transforming healthcare. With the integration of technology, clinical data and analytics, digital health is improving patient care, diagnostics and treatment methods. More specifically, Software-as-a-Medical-Device (SaMD)—a subsector of digital health—is gaining traction in both industry scale and innovative solutions. However, …

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Successful Development, Approval and Deployment of Digital Health Solutions

Successful Development, Approval and Deployment of Digital Health Solutions     For life sciences companies seeking to develop, deploy and successfully commercialize digital health products and solutions, the pathway to success can have many twists and turns, and be littered with false starts, roadblocks and more than a few misdirections. The pace of technological development—which is …

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MRI Safety Testing:  Making Implants More Compatible with Magnetic Resonance Imaging

MRI Safety Testing:  Making Implants More Compatible with Magnetic Resonance Imaging     Magnetic resonance imaging (MRI) is key when it comes to diagnosing and treating complex injuries or diseases. For spinal injuries or degeneration or different types of cancer there is rarely any better way to diagnose. Problems that may lead to serious conditions can …

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FDA Announces Expansion of Total Product Life Cycle Advisory Program Pilot

FDA Announces Expansion of Total Product Life Cycle Advisory Program Pilot     Beginning October 1, 2023, the FDA’s Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot will expand to include Neurological and Physical Medicine Devices. The FDA’s Center for Devices and Radiological Health (CDRH) developed the voluntary Total Product Life Cycle (TPLC) Advisory Program …

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