Rhaeos, Inc. Awarded $4 Million NIH SBIR Grant to Expand Quantitative Measurement Capabilities of its FlowSense™ Noninvasive Wireless Sensor

MINNEAPOLIS (Dec. 2, 2025) – Francis Medical, Inc., a privately-held medical device company developing the breakthrough Vanquish® Water Vapor Ablation System for the management of prostate cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for use of the Vanquish System for prostate tissue ablation. FDA clearance was supported by positive 12-month follow-up data on the first 110 patients enrolled in the company’s ongoing VAPOR 2 clinical study. The clearance marks a critical milestone for the company and enables a commercial launch of the Vanquish System.

WASHINGTON — AdvaMed, the medtech association, the world’s largest trade association representing medtech innovators, today released the following statement on the U.S. Centers for Medicare & Medicaid Services’ (CMS) release of its 2026 Home Health Prospective Payment System final rule:

Join Hogan Lovells experts to learn how the FDA is set to reshape the medical device regulatory landscape with the introduction of the QMSR.

As patient advocates, we’ve witnessed countless stories of hope deferred and lives put on hold while Medicare beneficiaries wait several years for access to breakthrough medical technologies that the FDA has already deemed safe and effective. This unacceptable delay between innovation and access must end. Innovation does not benefit patients without coverage.

WASHINGTON—AdvaMed, the world’s largest trade association representing medtech innovators, today welcomed a letter from U.S. Senators Susan Collins (R-Maine) and Jeanne Shaheen (D-N.H.), co-chairs of the Senate Diabetes Caucus, and U.S. Representatives Diana DeGette (D-Colo.-01) and Gus Bilirakis (R-Fla.-12), co-chairs of the U.S. House Diabetes Caucus, to Centers for Medicare and Medicaid Services (CMS) Administrator Mehmet Oz urging the agency not to finalize a proposal the lawmakers warned could reduce and complicate patient access to continuous glucose monitors (CGMs) and durable insulin pumps.

WASHINGTON, D.C. – AdvaMed, the Medtech Association, recently published a technical performance and safety bulletin titled, “Remote Device Operations: Common Challenges and Mitigation Strategies” to help health care providers, device manufacturers, and IT teams navigate the complex landscape of remotely managing medical devices.

WASHINGTON—AdvaMed, the medtech association, today thanked the U.S. House Energy and Commerce Health Subcommittee for highlighting the need for Medicare coverage of FDA-authorized breakthrough medtech and releasing a discussion draft of breakthrough coverage legislation at a hearing, “Examining Policies to Enhance Seniors’ Access to Breakthrough Medical Technologies.” 

WASHINGTON—AdvaMed, the medtech association, today welcomed U.S. House of Representatives Committee on Ways and Means passage of legislation providing Medicare coverage of FDA-designated and authorized breakthrough medtech. AdvaMed also urged legislators to add diagnostic tests to the measure, the Ensuring Patient Access to Critical Breakthrough Products Act, H.R. 5343.