TransMedics Group (TMDX) FDA Approvals $68.93 +0.08 (+0.12%) Closing price 05/22/2026 04:00 PM EasternExtended Trading$68.53 -0.40 (-0.58%) As of 05/22/2026 07:57 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsHeadlinesInsider TradesOptions ChainOwnershipSEC FilingsShort InterestTrendsBuy This Stock TransMedics Group's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by TransMedics Group (TMDX). Over the past two years, TransMedics Group has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as OCS™. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. OCS™ Heart System FDA Regulatory Events OCS™ Heart System is a drug developed by TransMedics Group for the following indication: For patients with end-stage lung, heart, and liver failure. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. FDA Approval - February 9,2026Fda Approval Investigational Device ExemptionDrug: OCS™ Heart SystemAnnounced Date: February 9, 2026Indication: For patients with end-stage lung, heart, and liver failureAnnouncementTransMedics Group, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted full approval of its Investigational Device Exemption (IDE) for the Next-Generation OCS ENHANCE Heart trial.AI SummaryTransMedics Group, Inc. announced that the U.S. Food and Drug Administration has granted full approval of its Investigational Device Exemption (IDE) for the Next-Generation OCS ENHANCE Heart trial. This IDE approval clears a key regulatory step and allows TransMedics to conduct a controlled clinical study in the United States using its next-generation Organ Care System (OCS) for heart transplants. The company can now enroll patients, collect safety and effectiveness data, and operate under the FDA-approved trial protocol. The trial will evaluate the updated OCS technology designed to keep donor hearts functioning outside the body for longer and under better conditions than cold storage. If successful, the study could support future regulatory filings and broader clinical use of the device, potentially increasing donor heart availability and improving transplant outcomes. TransMedics will now move forward with site activation and patient enrollment as outlined in the trial plan.Read AnnouncementConditional approval - August 4,2025Conditional Approval Investigational Device ExemptionDrug: OCS™ Heart SystemAnnounced Date: August 4, 2025Indication: For patients with end-stage lung, heart, and liver failureAnnouncementTransMedics Group, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted conditional approval of its Investigational Device Exemption (IDE), allowing the company to proceed with the initiation of its Next-Generation OCS ENHANCE Heart trial.AI SummaryTransMedics Group, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted conditional approval of its Investigational Device Exemption (IDE), clearing the way for the company’s Next-Generation OCS ENHANCE Heart trial. This two-part study will use the Organ Care System (OCS) Heart platform to test prolonged heart perfusion in Part A and compare OCS perfusion to standard cold storage in donation after brain death (DBD) cases in Part B. With over 650 patients planned, it is expected to become the largest heart preservation trial worldwide. Part B will include DBD hearts not currently eligible for OCS perfusion, with the goal of expanding future clinical indications. TransMedics plans to start enrolling patients in the fourth quarter of 2025, and full trial details will be posted on clinicaltrials.gov. Company leaders view the ENHANCE Heart trial as a key step toward broader clinical adoption in 2026 and beyond, aiming to improve organ quality, increase transplant success, and reset the standard of care for heart transplantation.Read Announcement TransMedics Group FDA Events - Frequently Asked Questions Has TransMedics Group received FDA approval? As of now, TransMedics Group (TMDX) has not received any FDA approvals for its therapy in the last two years. What drugs has TransMedics Group submitted to the FDA? In the past two years, TransMedics Group (TMDX) has reported FDA regulatory activity for OCS™ Heart System. What is the most recent FDA event for TransMedics Group? The most recent FDA-related event for TransMedics Group occurred on February 9, 2026, involving OCS™ Heart System. The update was categorized as "FDA Approval," with the company reporting: "TransMedics Group, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted full approval of its Investigational Device Exemption (IDE) for the Next-Generation OCS ENHANCE Heart trial." What conditions do TransMedics Group's current drugs treat? Currently, TransMedics Group has one therapy (OCS™ Heart System) targeting the following condition: For patients with end-stage lung, heart, and liver failure. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events AC Immune FDA EventsAgios Pharmaceuticals FDA EventsAssembly Biosciences FDA EventsBriacell Therap FDA EventsBioLineRx FDA EventsFibroBiologics FDA EventsGilead Sciences FDA EventsOncolytics Biotech FDA EventsRegeneron Pharmaceuticals FDA EventsAbbVie FDA EventsMerck & Co., Inc. FDA EventsAgenus FDA EventsAdagio Medical FDA EventsAktis Oncology FDA EventsAkari Therapeutics FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies Glaukos FDA Events Liquidia FDA Events MiniMed Group FDA Events Soleno Therapeutics FDA Events AxoGen FDA Events NovoCure FDA Events Pulse Biosciences FDA Events PROCEPT BioRobotics FDA Events Inspire Medical Systems FDA Events Artivion FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:TMDX last updated on 2/9/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. From Our PartnersHey, it's Jon Najarian. The SpaceX IPO is right around the corner. But I discovered Elon may have something BIGGER planned. Check this out before June 9th...After being invited to the SpaceX launch headquarters in Cape Canaveral from one of Elon's top lobbyists… Hall...Banyan Hill Publishing | SponsoredBetter than SpaceX? Grab this ticker instead.Larry Benedict generated $274 million for his clients by finding the trades most investors missed. Now he says...Brownstone Research | SponsoredFrom the man who predicted 2008 crash…Porter Stansberry, founder of one of the largest financial research firms in the world, says he's breaking the...Porter & Company | SponsoredThree companies about to leapfrog Nvidia [And transform the entire industry]Futurist George Gilder - who predicted the smartphone years before the iPhone launched - believes today's AI d...Eagle Publishing | SponsoredGoldman Sachs just told you what to buy (most people missed it)Goldman Sachs just revealed that 40% of AI data centers will be crippled by electricity shortages by 2027 - no...Behind the Markets | SponsoredThe worst mistake you can make with the SpaceX IPOThe $1.75 trillion SpaceX IPO is generating massive hype - but history shows retail investors who pile in on d...Weiss Ratings | SponsoredYour $29.97 book is free todayBill Poulos is giving away his 'Safe Trade Options Formula' book at no charge - the same book that sells for $...Profits Run | Sponsored Adding Choose a watchlist: Watchlist Adding You have already added ten stocks to your watchlist. Upgrade to MarketBeat All Access to add more stocks to your watchlist. Adding TransMedics Group, Inc. Please log in to your account or sign up in order to add this asset to your watchlist. Share TransMedics Group With A Colleague Link copied to clipboard. Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. Start Your 30-Day Trial MarketBeat All Access Features Best-in-Class Portfolio Monitoring Get personalized stock ideas. Compare portfolio to indices. Check stock news, ratings, SEC filings, and more. Stock Ideas and Recommendations See daily stock ideas from top analysts. Receive short-term trading ideas from MarketBeat. Identify trending stocks on social media. Advanced Stock Screeners and Research Tools Use our seven stock screeners to find suitable stocks. Stay informed with MarketBeat's real-time news. Export data to Excel for personal analysis. Sign in to your free account to enjoy these benefits In-depth profiles and analysis for 20,000 public companies. Real-time analyst ratings, insider transactions, earnings data, and more. Our daily ratings and market update email newsletter. Sign in to your free account to enjoy all that MarketBeat has to offer. Sign In Create Account Your Email Address: Email Address Required Your Password: Password Required Log In Email Me a Login Link or Sign in with Facebook Sign in with Google Forgot your password? Your Email Address: Please enter your email address. Please enter a valid email address Choose a Password: Please enter your password. Your password must be at least 8 characters long and contain at least 1 number, 1 letter, and 1 special character. Create My Account (Free) or Sign in with Facebook Sign in with Google By creating a free account, you agree to our terms of service. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
FDA Approval - February 9,2026Fda Approval Investigational Device ExemptionDrug: OCS™ Heart SystemAnnounced Date: February 9, 2026Indication: For patients with end-stage lung, heart, and liver failureAnnouncementTransMedics Group, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted full approval of its Investigational Device Exemption (IDE) for the Next-Generation OCS ENHANCE Heart trial.AI SummaryTransMedics Group, Inc. announced that the U.S. Food and Drug Administration has granted full approval of its Investigational Device Exemption (IDE) for the Next-Generation OCS ENHANCE Heart trial. This IDE approval clears a key regulatory step and allows TransMedics to conduct a controlled clinical study in the United States using its next-generation Organ Care System (OCS) for heart transplants. The company can now enroll patients, collect safety and effectiveness data, and operate under the FDA-approved trial protocol. The trial will evaluate the updated OCS technology designed to keep donor hearts functioning outside the body for longer and under better conditions than cold storage. If successful, the study could support future regulatory filings and broader clinical use of the device, potentially increasing donor heart availability and improving transplant outcomes. TransMedics will now move forward with site activation and patient enrollment as outlined in the trial plan.Read Announcement
Conditional approval - August 4,2025Conditional Approval Investigational Device ExemptionDrug: OCS™ Heart SystemAnnounced Date: August 4, 2025Indication: For patients with end-stage lung, heart, and liver failureAnnouncementTransMedics Group, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted conditional approval of its Investigational Device Exemption (IDE), allowing the company to proceed with the initiation of its Next-Generation OCS ENHANCE Heart trial.AI SummaryTransMedics Group, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted conditional approval of its Investigational Device Exemption (IDE), clearing the way for the company’s Next-Generation OCS ENHANCE Heart trial. This two-part study will use the Organ Care System (OCS) Heart platform to test prolonged heart perfusion in Part A and compare OCS perfusion to standard cold storage in donation after brain death (DBD) cases in Part B. With over 650 patients planned, it is expected to become the largest heart preservation trial worldwide. Part B will include DBD hearts not currently eligible for OCS perfusion, with the goal of expanding future clinical indications. TransMedics plans to start enrolling patients in the fourth quarter of 2025, and full trial details will be posted on clinicaltrials.gov. Company leaders view the ENHANCE Heart trial as a key step toward broader clinical adoption in 2026 and beyond, aiming to improve organ quality, increase transplant success, and reset the standard of care for heart transplantation.Read Announcement
