Medical Innovation Exchange

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Medcrypt Appoints Former FDA Officer to Vice President of Services

Medcrypt Appoints Former FDA Officer to Vice President of Services     Naomi Schwartz, former premarket reviewer and consumer safety officer for the FDA, has been promoted to serve as Vice President of Services at Medcrypt, a cybersecurity solution provider for medical device manufacturers. In this new role, Schwartz will provide regulatory guidance to medtech companies …

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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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Drivers and Implications of Multi-Billion Dollar Acquisitions in Medtech

Drivers and Implications of Multi-Billion Dollar Acquisitions in Medtech     After a busy 2021, medical technology (medtech) mergers and acquisitions (M&As) dropped in 2022 largely due to the impacts of COVID-19, rising inflation and supply chain challenges. But some medtech companies were able to launch megadeals in 2022 despite macroeconomic conditions.[1] While billion-dollar deals are …

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The Power of AI to Enhance Clinical Trials

The Power of AI to Enhance Clinical Trials     Clinical trials are essential to the development and implementation of safer and more effective devices and medications, but clinical trial success rates have been shockingly low. The likelihood of a new drug advancing to the next trial stage or regulatory approval is less than 14% across …

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FDA Updates Breakthrough Devices Program Guidance

FDA Updates Breakthrough Devices Program Guidance     The FDA has issued an update to the final guidance: Breakthrough Devices Program. The updates are intended to clarify how the Breakthrough Devices Program applies to certain innovative medical devices that may address health inequities, as well as devices that may offer a non-addictive option to treat pain or …

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FDA Issues Three New Draft Guidances on the 510(k) Program

FDA Issues Three New Draft Guidances on the 510(k) Program     On September 6, the FDA published three new draft guidances as part of its efforts to modernize the 510(k) Program with the goal of improving the safety of medical devices while continuing to bring critical devices to patients. The new guidances include: On October …

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EU MDR Annex XVI Introduces New Burdens for Products Without an Intended Medical Purpose

EU MDR Annex XVI Introduces New Burdens for Products Without an Intended Medical Purpose     Adopted in 2017, the EU Medical Device Regulation (MDR) brought a host of changes. In its Annex XVI, for example, the regulation expands its scope to take in new product groups referred to as “products without an intended medical purpose”—in …

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Get Well Achieves FedRAMP Authorized Designation

Get Well Achieves FedRAMP Authorized Designation     Get Well, a provider of enterprise digital patient experience and navigation solutions for hospitals and communities, announced that it has achieved Federal Risk and Authorization Management Program (FedRAMP) authority to operate (ATO) at the Moderate security impact level for its cross-continuum digital patient engagement platform. FedRAMP is a …

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MedTech Marketing Pearls for FDA Clearance and Beyond

MedTech Marketing Pearls for FDA Clearance and Beyond      Product marketing touches every function of a MedTech organization. I often describe it as the central spoke of the wheel, or the business lead that directs and guides each function in critical ways. Marketing know-how keeps a company ahead of market trends and perceptions. These insights …

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FDA CDRH To Host Virtual Workshop to Enhance Clinical Study Diversity

FDA CDRH To Host Virtual Workshop to Enhance Clinical Study Diversity     The FDA, in collaboration with the Clinical Trials Transformation Initiative (CTTI), is soliciting input on how to enhance clinical study diversity. They will be hosting a two-day virtual public workshop on increasing the enrollment of historically underrepresented populations in clinical studies and encouraging …

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