Baird Medical Announces Regulatory Milestones in Vietnam and Egypt, Expanding International Reach of Microwave Ablation Technology
Vietnam registrations broaden the approved portfolio, while Egypt's regulatory process remains at the preliminary approval stage.
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Rhea-AI Summary
Baird Medical (BDMD) announced additional medical device registrations in Vietnam and preliminary regulatory approval in Egypt for its microwave ablation technology.
Vietnam issued Class C registration certificates for J-series needles for benign thyroid nodules, G-series needles for liver tumors, and MTI-5AT and MTI-5ET generators, following an initial registration in January 2026. Egypt's Drug Authority granted preliminary approval for the BD-GT Microwave Ablation System and related accessories in January 2026, ahead of potential final registration of the system's sterile accessories. The company plans to strengthen U.S. commercial infrastructure and physician engagement following FDA 510(k) clearance in November 2023.
Positive
- Minor pointVietnam Class C registrations cover J-series and G-series needles and MTI-5AT and MTI-5ET generators.
- Minor pointEgypt granted preliminary approval for the BD-GT system and related accessories in January 2026.
- Minor point. Forward-looking: it has not happened yet and may not happen.U.S. commercial plans include strengthening infrastructure and physician engagement following November 2023 FDA 510(k) clearance.
Negative
- Minor point. Forward-looking: it has not happened yet and may not happen.Egypt's final registration of sterile accessories remains potential; approval is preliminary.
Key Figures
- Egypt preliminary approval
- January 2026
- EDA approval for BD-GT Microwave Ablation System and related accessories
Historical Context
-
Reported first microwave ablation procedures in Vietnam and Argentina and Pakistan system registration.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
microwave ablation medical
510(k) clearance regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
Company Continues to Advance Global Regulatory Strategy While Supporting U.S. Commercial Expansion
NEW YORK, Oct. 19, 2026 (GLOBE NEWSWIRE) -- Baird Medical Investment Holdings Limited (NASDAQ: BDMD) (“Baird Medical” or the “Company”), a global leader in microwave ablation (MWA) technology, today announced additional medical device registrations in Vietnam and preliminary regulatory approval in Egypt. The preliminary approval in Egypt will help the Company bring its technology to one of the largest markets in the Middle East, while the product registrations in Vietnam will enable Baird to expand the addressable patient population in this key Southeast Asian country. These milestones reflect the continued successful execution of the Company’s international growth and diversification strategy.
In Vietnam, Baird Medical received Class C medical device registration certificates for several products within its microwave ablation portfolio, including its J-series microwave ablation needles for benign thyroid nodules, G-series needles for liver tumors, and MTI-5AT and MTI-5ET microwave ablation generators. The certificates, which follow an initial product registration issued in January 2026, represent an important step in expanding the Company's footprint in Southeast Asia and supporting future commercialization opportunities in the region.
Additionally, the Egyptian Drug Authority (EDA) granted preliminary approval for Baird Medical's BD-GT Microwave Ablation System and related accessories in January 2026. The preliminary approval marks progress toward establishing a regulatory pathway for the Company's technology in the Egyptian market, in advance of a potential final registration of the system’s sterile accessories.
“Securing medical device registrations in Vietnam and advancing through the regulatory process in Egypt are important steps in expanding the presence of our microwave ablation technology in strategic markets beyond the U.S. and PRC,” said Haimei Wu, Chairwoman and CEO of Baird Medical. “These developments demonstrate our ability to navigate regulatory requirements across different jurisdictions and expand the reach of our technology across multiple clinical applications, including thyroid nodules and liver tumors. At the same time, we are focused on continuing to translate our FDA clearance into accelerating commercial traction in the United States by strengthening our physician relationships and expanding adoption of microwave ablation technology. We see strong opportunities to build on our established international presence while establishing a larger foothold in the U.S. market.”
The international regulatory developments build on Baird Medical's broader growth strategy, which includes expanding its presence in established markets while accelerating commercial activities in the United States following FDA 510(k) clearance for its microwave ablation technology in November 2023. Baird Medical continues to expand its international regulatory footprint across markets including Argentina, Vietnam, Indonesia, and Pakistan, while advancing the regulatory process in Egypt. The Company continues to focus on strengthening its commercial infrastructure, increasing physician engagement, and building awareness of microwave ablation as a minimally invasive treatment option for a range of indications.
As part of these efforts, Baird Medical will attend the American Thyroid Association (ATA) Annual Meeting, taking place November 4-7, 2026, in Philadelphia, Pennsylvania. The meeting will bring together clinicians, researchers, and industry leaders focused on advancing thyroid care, providing an opportunity for the Company to engage with the medical community and support awareness of microwave ablation technology for the treatment of benign thyroid nodules.
About Baird Medical
Baird Medical is a global, pioneering medical device company specializing in minimally invasive ablation technologies for a range of solid tumors. The Company’s lead product, a microwave ablation (MWA) system, is FDA-cleared for soft tissue ablation and is being launched in the U.S. primarily for the treatment of benign thyroid nodules. In addition, the Company is expanding its minimally invasive technology portfolio, including IRE-based products and an AI-powered robotic ablation system.
Baird Medical's MWA solutions have been adopted by a growing number of leading U.S. institutions and private practice groups, including the Mayo Clinic, Columbia University Medical Center, and The George Washington University Hospital. The company is rapidly expanding its global commercial footprint, with sales now reaching markets across multiple continents.
Forward-Looking Statements
This press release includes certain statements that are not historical facts but are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or Baird Medical's future financial or operating performance. In some cases, you can identify forward-looking statements by terminology such as "may", "could", "should", "expect", "intend", "might", "will", "estimate", "anticipate", "believe", "budget", "forecast", "intend", "plan", "potential", "predict", or "continue", or the negatives of these terms or variations of them or similar terminology. Forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Baird Medical and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Baird Medical does not undertake any duty to update these forward-looking statements.
Actual results may vary materially from those expressed or implied by forward-looking statements based on a number of factors, including, without limitation: (1) the risk that Baird Medical may not be successful in expanding its business in China or the United States; (2) changes in general economic conditions; (3) regulatory conditions and developments; (4) changes in applicable laws or regulations; (5) the nature, cost and outcome of pending and future litigation and other legal proceedings instituted against Baird Medical or others; and (6) other risks and uncertainties from time to time described in the Registration Statement relating to the Business Combination and the transition report, including those listed under the sections titled "Risk Factors" therein, and in ExcelFin's other filings with the SEC.
The foregoing list of factors is not exclusive. Additional information concerning certain of these, and other risk factors is contained in ExcelFin's most recent filings with the SEC and in the Registration Statement described above filed by Baird Medical in connection with its business combination with ExcelFin. All subsequent written and oral forward-looking statements concerning Baird Medical, the business combination described herein, or other matters attributable to Baird Medical or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements above. Readers are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Baird Medical expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.
Contact:
Lee Roth
Burns McClellan for Baird Medical
Lroth@burnsmc.com
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
Which Baird Medical products received registrations in Vietnam?
Vietnam issued Class C medical device registration certificates for J-series microwave ablation needles for benign thyroid nodules, G-series needles for liver tumors, and MTI-5AT and MTI-5ET generators. These follow an initial product registration issued in January 2026.
Has Baird Medical received final regulatory approval in Egypt?
The Egyptian Drug Authority granted preliminary approval for the BD-GT Microwave Ablation System and related accessories in January 2026. Final registration of the system's sterile accessories remains a potential next step, not a completed approval.