Spectrumedics Sonico-CX Coronary Intravascular Lithotripsy System Receives CE Mark Approval

January 6, 2026—Spectrumedics Medical announced that its Sonico-CX intravascular lithotripsy (IVL) system has obtained CE Mark certification under the European Union Medical Device Regulation (EU MDR).

Recommendations for Clinical Investigations of High-Risk Medical Devices in Europe Published by CORE-MD

September 16, 2025—The European Society of Cardiology (ESC) announced that CORE-MD, the Coordinating Research and Evidence for high-risk Medical Devices consortium, published new consensus recommendations by Professor Alan G. Fraser, MD, et al in The Lancet Regional Health Europe that set out scientifically robust methodologies for clinical investigations of high-risk medical devices.

FDA Begins Real-Time Reporting of Adverse Event Data

August 25, 2025—The FDA announced it has commenced daily publication of adverse event data from the FDA Adverse Event Reporting System (FAERS).

CMS Approves NTAP for Renata’s Minima Stent System

August 12, 2025—Renata Medical announced that the Centers for Medicare & Medicaid Services (CMS) has granted a New Technology Add-on Payment (NTAP) for the company’s Minima stent system under the Inpatient Prospective Payment System for Fiscal Year 2026, effective October 1, 2025.

FTC Seeks to Block Edwards Acquisition of JenaValve

August 6, 2025—The Federal Trade Commission (FTC) announced it has moved to block Edwards Lifesciences’ proposed acquisition of JenaValve Technology, Inc. because of concerns that the acquisition would limit patient access to lifesaving transcatheter aortic valve replacement (TAVR) medical devices used to treat aortic regurgitation (AR).

Boston Scientific’s Agent DCB Granted NTAP From CMS

August 4, 2025—Boston Scientific recently announced that the US Centers for Medicare & Medicaid Services (CMS) granted a New Technology Add-on Payment (NTAP) for the company’s Agent drug-coated balloon (DCB).

CVRx Reports Barostim CMS Reimbursement Updates

July 16, 2025—CVRx, Inc. announced that the Centers for Medicare and Medicaid Services (CMS) has proposed to keep the company’s Barostim implantation procedure as part of the New Technology Ambulatory Payment Classification (APC) 1580, with an associated payment of approximately $45,000 for procedures performed in the outpatient setting.

CMS Approves Coverage for T-TEER to Treat Tricuspid Regurgitation

July 11, 2025—The United States Centers for Medicare & Medicaid Services (CMS) recently announced it has issued a National Coverage Determination (NCD) that covers FDA-approved tricuspid transcatheter edge-to-edge repair (T-TEER) for the treatment of symptomatic tricuspid regurgitation (TR) under Coverage with Evidence Development (CED), when furnished in accordance with the coverage criteria specified in the NCD.

CMS Seeks Comments on Proposed Decision Memo for RDN to Treat Hypertension

July 10, 2025—The Centers for Medicare & Medicaid Services (CMS) issued a proposed decision memo for its National Coverage Analysis (NCA) of renal denervation (RDN)—including radiofrequency (rfRDN) and ultrasound (uRDN) treatments—for uncontrolled hypertension under Coverage with Evidence Development (CED).

CMS Initiates NCA on Renal Denervation for Uncontrolled Hypertension

January 13, 2025—Medtronic and Recor Medical, Inc. separately announced that the Centers for Medicare & Medicaid Services (CMS) is opening a national coverage analysis (NCA; CAG-00470N) on renal denervation (RDN) for uncontrolled hypertension.

FDA Issues Draft Guidance for Development of AI-Enabled Medical Devices

January 6, 2025—The FDA announced it has issued draft guidance for recommendations to support development and marketing of safe and effective artificial intelligence (AI)–enabled devices throughout the device’s Total Product Life Cycle.

UK NICE Draft Guidance Reports No Evidence to Justify Price Variation of TAVI Devices in NHS

August 22, 2024—The United Kingdom’s National Institute for Health and Care Excellence (NICE) recently announced a Draft Guidance on heart valves used in transcatheter aortic valve implantation (TAVI) by the National Health Services (NHS).

Viz.ai’s Hypertrophic Cardiomyopathy AI Algorithm Approved by FDA

August 15, 2023—Viz.ai announced it has received FDA de novo approval by for the company’s hypertrophic cardiomyopathy (HCM) artificial intelligence (AI) detection algorithm, the Viz HCM module, creating a new regulatory category for cardiovascular machine learning-based notification software.

CMS Proposes Coverage Expansion for Carotid Artery Stenting

July 13, 2023—The Centers for Medicare & Medicaid Services (CMS) released a decision memo proposing expanded coverage for percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting (CAS), including that coverage of the procedure is reasonable and necessary with the placement of an FDA-approved carotid stent with an FDA-approved or FDA-cleared embolic protection device, for Medicare beneficiaries under specified conditions.

CMS Issues Proposed Transitional Coverage for Emerging Technologies Pathway and Revamped Evidence Development Framework

July 3, 2023—The Centers for Medicare & Medicaid Services (CMS) recently announced a proposed Transitional Coverage for Emerging Technologies (TCET) pathway.

FDA Draft Guidance Recommends Additional Steps to Modernize Clinical Trials

June 6, 2023—The FDA announced the availability of a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical trials to make trials more agile without compromising data integrity or participant protections.

FDA Issues Draft Guidance on Implementing Decentralized Clinical Trials

May 2, 2023—The FDA announced additional steps to support the use of decentralized clinical trials (DCTs) for drugs, biologics, and devices, where some or all the trial-related activities occur at locations other than traditional clinical trial sites.

NAMSA Acquires Market Research Firm SUAZIO

March 27, 2023—NAMSA, a medical device–focused contract research organization headquartered in Toledo, Ohio, announced its acquisition of SUAZIO, an Antwerp, Belgium–based strategic consultancy.

Neovasc’s Reducer Granted German Reimbursement Renewal

February 1, 2023—Neovasc, Inc. announced that the German Institute for the Hospital Remuneration System (InEK) has awarded NUB Status 1 designation for 2023 for the company’s Reducer device.