Bluegrass Vascular Announces Decision by Medicare to Assign a New Technology Ambulatory Payment Classification (APC) for the Surfacer® System Procedure

Join Hogan Lovells in this webinar will examine FDA for-cause inspections as they relate to medical device manufacturers.

WASHINGTON—AdvaMed, the Medtech Association, today applauded House of Representatives passage of S. 3971, the Small Business Innovation and Economic Security Act, legislation reauthorizing the federal Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. House passage follows Senate passage earlier this month, bringing the restoration of these initiatives one step closer to completion.  

WASHINGTON—AdvaMed, the Medtech Association, today welcomed Senate approval of legislation reauthorizing the federal Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs and urged the House of Representatives to act swiftly on passage.

HALIFAX, NS, Feb. 24, 2026 /PRNewswire/ – ABK Biomedical, Inc., an innovative, medical device company dedicated to the research, development, and commercialization of advanced imageable embolic medical devices, today announced the completion of patient enrollment in its pivotal U.S. FDA Investigational Device Exemption (IDE) study, ROUTE90. The study evaluates Eye90 microspheres®, a novel Yttrium-90 (Y90) radioembolization device, for the treatment of hepatocellular carcinoma (HCC), the most common form of primary liver cancer.

ATRO Medical, the Dutch clinical-stage orthopedic company developing a novel artificial meniscus implant for patients suffering from post-meniscectomy pain, today announces the successful closing of a €3 million financing round. The financing round is primarily composed of equity investments, complemented by non-dilutive funding. It brings together MedTech investors from the Netherlands, Switzerland, and the United Arab Emirates such as 819 Capital, Thuja Capital, Bolwork International Investment and industry leaders DSM-Firmenich Ventures and Samaplast.

AdvaMed’s® Comment Letter to ASTP/ONC, outlines concrete policy reforms across FDA oversight, CMS payment pathways, and HIPAA data-sharing rules to accelerate patient access to AI-enabled medical technologies. As AI-enabled medical devices transform patient care, outdated regulatory, coverage, and privacy frameworks are slowing the pace of adoption.

PALO ALTO, Calif., Feb. 11, 2026 i-GENTIC AI today announced a new suite of context-aware, multilingual MedTech agents designed to help medical device manufacturers improve the quality and consistency of FDA 510(k) submissions. Preparing a 510(k) often takes months, yet many submissions require additional information requests or are rejected due to inconsistencies across documents, evidence, and claims, creating delays and added costs for manufacturers.

Explore AdvaMed’s Medical Device Submissions Workshop Series from practical submission strategies to live expert insights you can apply immediately.