AdvaMed Medical Device Submission Workshop Series
Join industry leaders for the in-depth Medical Device Submissions Workshop series to receive real-world case studies, timely submissions tips, and best practices.
Regulatory Affairs
Learn more about our Regulatory Affairs work.
Emanate Receives FDA 510(k) Clearance for Perio PODS™, the First FDA-Cleared At-Home Periodontal Wound Dressing Indicated Following Non-Surgical Periodontal Procedures
NEW YORK, Sept. 17, 2026 (GLOBE NEWSWIRE) — Emanate Biomedical, Inc., a medical technology company creating a new category of clinician-directed at-home oral care, today announced U.S. Food and Drug…
Shifting Customer Engagement Models in Diagnostics: Winning in a Rapidly Evolving Market
Join Deloitte in this discussion examining how rising consumer expectations, new technology entrants, and evolving provider roles are reshaping how diagnostics manufacturers engage their customers.
Reimagining the Cost of Quality: The Agentic AI Opportunity for MedTech
Join HCLTech in this discussion about practical use cases and strategies to scale AI-driven quality operations while maintaining compliance and enabling greater innovation.
AdvaMed Welcomes Expiration of Moratorium on New Medicare Durable Medical Equipment Suppliers
WASHINGTON—Scott Whitaker, president and CEO of AdvaMed, the medtech association, today welcomed the expiration of the moratorium on Medicare acceptance of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers.…
Cubresa Announces FDA 510(k) Clearance for the Cubresa BrainPET™ Scanner, Opening New Frontier in Clinical Brain Imaging
WINNIPEG, MANITOBA, CANADA, August 20, 2026 /EINPresswire.com/ — Cubresa Inc., a global leader in clinical and preclinical molecular imaging technologies, today announced that it has received FDA 510(k) clearance from the U.S.…
AdvaMed Statement on the Nomination of Dr. Heidi Overton as FDA Commissioner
WASHINGTON—Scott Whitaker, president and CEO of AdvaMed, the medtech association, made the following comment on President Trump’s nomination of Dr. Heidi Overton to serve as FDA commissioner.
Software as a Medical Device: From Regulatory Strategy to Market Readiness
Join MIDI as they provide a practical framework for developing SaMD products with regulatory requirements built into the development process.
From Data Chaos to Trusted AI in MedTech:
Data Quality, Knowledge Graphs & Semantic Layers That Make It Possible
Join Genpact as they provide a practical framework for connecting, governing, and activating service data – and a clear roadmap for scaling AI from pilot to confident business outcomes.
MedSource Labs Launches ClearSafe Comfort® Closed System, Rounding Out Its Full Line of Peripheral IV Catheters
Chanhassen, MN — MedSource Labs today announced the launch of the ClearSafe Comfort® Closed System, the first slide-activated safety peripheral IV catheter (PIVC) with an integrated extension set to receive…