Baird Medical Attains FDA Clearance to Market Its Microwave Ablation System in the United States
FRISCO, Texas, Nov. 21, 2023 /PRNewswire/ -- Baird Medical Devices, Inc. ("Baird Medical" or the "Company"), a leading microwave ablation ("MWA") medical device developer and provider in China, today announced that its subsidiary, Betters (Suzhou) Medical Co., Ltd, has received clearance from the U.S. Food and Drug Administration (the "FDA") under Section 510 (K) to begin marketing its portfolio of Microwave Ablation Systems and Disposable Microwave Ablation Needles as regulatory Class II devices in the United States.
- FRISCO, Texas, Nov. 21, 2023 /PRNewswire/ -- Baird Medical Devices, Inc. ("Baird Medical" or the "Company"), a leading microwave ablation ("MWA") medical device developer and provider in China, today announced that its subsidiary, Betters (Suzhou) Medical Co., Ltd, has received clearance from the U.S. Food and Drug Administration (the "FDA") under Section 510 (K) to begin marketing its portfolio of Microwave Ablation Systems and Disposable Microwave Ablation Needles as regulatory Class II devices in the United States.
- Ms. Haimei Wu, Founder and CEO of Baird Medical, commented, "Attaining FDA clearance represents a significant milestone in our geographical expansion.
- This clearance grants us the ability to market our portfolio of MWA systems and disposable needles in the United States.
- Based on our market research, we estimate that the U.S. presents a market opportunity of $1.6 billion for MWA systems alone.