Guardant Health’s Shield™ Blood Test Approved by FDA as a Primary Screening Option, Clearing Path for Medicare Reimbursement and a New Era of Colorectal Cancer Screening

Join industry leaders for the in-depth Medical Device Submissions Workshop series to receive real-world case studies, timely submissions tips, and best practices.

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 Administration (FDA) 510(k) clearance for Perio PODS™, a periodontal wound dressing consisting of single-use, patient-matched dental trays preloaded with engineered hydrogel.

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.

Join HCLTech in this discussion about practical use cases and strategies to scale AI-driven quality operations while maintaining compliance and enabling greater innovation.

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. He made the following comment on the expiration. 

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. Food and Drug Administration (FDA) for its groundbreaking Cubresa BrainPET™ scanner.

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. 

Join MIDI as they provide a practical framework for developing SaMD products with regulatory requirements built into the development process.