Join J&J, Pfizer and FDA at the Supply Chain Summit and Advanced...
Supply chain challenges and the move to advanced manufacturing are two key issues affecting the Medtech industry. On November 7-9, MedTech Intelligence will be hosting the MedTech Advanced...
View ArticleFDA 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...
View ArticleMedTech 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....
View ArticleGet 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...
View ArticleEU MDR Annex XVI Introduces New Burdens for Products Without an Intended...
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...
View ArticleFDA 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...
View ArticleFDA 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...
View ArticleThe 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...
View ArticleDrivers 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...
View ArticleUnlocking 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...
View ArticleMedcrypt 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...
View ArticleOvercoming Forecasting Challenges in Cell and Gene Therapies
Forecasting is a vital activity that supports a range of key business decisions across a broad range of stakeholders in pharma and medtech. And it is not just about crunching numbers; it’s about...
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