FDA Panel Eyes New Heart Shunt Device Approval
Published Date: 11/3/2025
Notice
Summary
The FDA is hosting a virtual meeting on December 3, 2025, to discuss the V-Wave Ventura Interatrial Shunt System, a device that helps with heart blood flow. They’re inviting the public to share their thoughts by January 3, 2026, which could impact how this device is reviewed and possibly approved. This affects patients, doctors, and companies involved in heart health, with no direct costs announced yet.
Analyzed Economic Effects
5 provisions identified: 4 benefits, 0 costs, 1 mixed.
Advisory Panel Will Vote on Heart-Shunt PMA
On December 3, 2025, the FDA's Circulatory System Devices Panel will discuss, make recommendations, and vote on the premarket approval (PMA) application from V‑Wave, Inc. for the V‑Wave Ventura Interatrial Shunt System, a permanent implant indicated for New York Heart Association (NYHA) Class III heart failure patients who remain symptomatic despite guideline‑directed medical therapy.
Public Comments Accepted Through Jan 3, 2026
The FDA established docket FDA‑2025‑N‑4679 and will accept public comments through 11:59 p.m. Eastern Time on January 3, 2026. Comments submitted on or before November 14, 2025 will be provided to the Committee; later comments will be taken into consideration by FDA.
How to Request an Oral Presentation
Individuals wishing to make formal oral presentations must notify the contact person and submit a brief statement of the evidence or arguments, names/addresses of participants, and requested time by November 3, 2025; oral presentations are scheduled on December 3, 2025, between approximately 2 p.m. and 3 p.m. Eastern Time and may be time‑limited or selected by lottery if demand exceeds available slots.
Virtual Meeting with Accessibility Accommodations
The meeting will be held virtually on December 3, 2025 (9 a.m. to 6 p.m. ET) with presentations heard, captioned, recorded, and viewable online; persons requiring disability accommodations should contact CDR Daniel Bailey at Daniel.Bailey@fda.hhs.gov or 301-796-0048 at least 7 days before the meeting.
Procedure for Confidential Comment Submissions
If you want to submit confidential information, you must send a written/paper submission with two copies: one labeled "THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION" (for FDA review) and a second redacted copy for public viewing; confidential information will be handled under 21 CFR 10.20.
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-10295 — M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP); International Council for Harmonisation; Guidance for Industry; Availability
The FDA just released a new, easy-to-use digital guide called M11 CeSHarP to help everyone involved in clinical trials share and review study plans faster and clearer. This affects drug companies, researchers, and regulators worldwide by setting a global standard for how trial info is written and shared electronically. The new rules kick in now, aiming to save time and reduce confusion, with no direct cost but big efficiency gains.
2026-10268 — Notice of Decision Not To Designate Hepatitis Delta Virus Diseases as an Addition to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act
The FDA decided not to add Hepatitis Delta Virus (HDV) to the list of tropical diseases because it doesn’t fully meet the rules about market size and who it affects. This means drug makers won’t get special priority review vouchers for HDV treatments right now. People working on HDV drugs should keep an eye out for future updates but won’t see changes or new incentives immediately.
2026-10284 — Protein Efficiency Ratio Rat Bioassay Studies To Demonstrate That a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein; Guidance for Industry; Availability
The FDA just released new guidance to help baby formula makers prove their products have good-quality protein using special rat studies. This update affects formula manufacturers and labs, making it easier and clearer to show their formulas meet nutrition standards. The guidance is effective now, helping companies avoid costly mistakes and speed up getting new formulas to market.
2026-10321 — Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Safety and Effectiveness of MFLUSIVA (Influenza Vaccine, mRNA) Manufactured by Moderna TX Inc.
The FDA is holding a public meeting on June 18, 2026, to talk about the safety and effectiveness of MFLUSIVA, a new flu vaccine made by Moderna. Anyone can watch online and share their thoughts before June 17. This is a big deal for people who get flu shots and could affect how this vaccine is used and approved.
2026-10277 — Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
The FDA just released new draft guides to help drug makers design studies proving their generic drugs work like the originals. If you’re in the drug business, now’s your chance to share feedback by July 21, 2026, before these guides become final. These updates aim to speed up drug approvals, potentially saving time and money for companies and patients alike!
2026-10190 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Patent Term Restoration; Due Diligence Petitions; Filing, Format, and Content of Petitions
The FDA is updating how companies ask for extra patent time when their new drugs or devices take a while to get approved. This affects drug and medical device makers who want to protect their inventions longer. Comments on these changes are open until June 22, 2026, and the update aims to keep the process clear without adding extra costs or delays.
Previous / Next Documents
Previous: 2025-19763 — Cost-of-Living Increase and Other Determinations for 2026
Starting December 2025, Social Security benefits will get a 2.8% boost, helping millions keep up with rising costs. This means higher monthly payments for retirees, disabled folks, and some veterans, plus updated limits on earnings and fees for 2026. If you get Social Security or Supplemental Security Income, expect a little more money in your pocket next year!
Next: 2025-19764 — Sunshine Act Meetings
The National Credit Union Administration is holding an open meeting on November 5, 2025, to discuss its budget for 2026-2027. This affects credit unions and anyone interested in how their money is managed. The meeting is a chance to see transparency in action with no cost changes announced yet.