United States Smoke Evacuation Systems Market Assessment, By Product, By Application, By End-user, By Region, Opportunities and Forecast, 2018-2032F

United States smoke evacuation systems market is projected to witness a CAGR of 6.70% during the forecast period 2025-2032, growing from USD 61.37 million in 2024 to USD 103.11 million in 2032. The growing preference for minimally invasive surgeries (MIS) in the United States is driving the demand for effective smoke evacuation systems, as these procedures generate harmful surgical smoke. Continuous advancements in smoke evacuation filters and compact, high-efficiency portable systems are improving their performance and usability, further accelerating market growth. Furthermore, strict health and occupational safety regulations at the federal and state levels are pushing healthcare facilities to implement advanced smoke evacuation solutions to ensure compliance and protect surgical staff.

For instance, CONMED Corporation (US) received USFDA approval for its PlumeSafe X5 Smoke Management System in August 2024. It is a portable, stand-alone system designed to capture surgical smoke and return clean air.

Growing State-Level Regulations for Surgical Smoke Evacuation

Surgical smoke evacuation is gaining regulatory traction across the United States due to rising awareness of its health hazards among healthcare workers. Organizations like the Association of periOperative Registered Nurses (AORN) and the American Nurses Association (ANA) have been actively advocating for laws requiring smoke evacuation systems in operating rooms. Surgical smoke contains over 150 hazardous chemicals, including benzene, formaldehyde, and hydrogen cyanide, which pose serious respiratory and long-term health risks. Due to these dangers, hospitals and ASCs must comply with evolving regulations, prompting a surge in demand for advanced smoke evacuation technologies. Currently, multiple states, including California, Rhode Island, and Illinois, have implemented legal requirements, and more states are expected to follow. As state-level mandates continue to expand, medical facilities must adopt smoke evacuation solutions, driving significant market growth. For example, in April 2024, Minnesota became the 15th U.S. state to pass legislation mandating smoke evacuation systems in operating rooms. This law requires all hospitals and ASCs to implement surgical smoke control measures by July 2025, aligning with similar laws in the states of Colorado and New Jersey. (Minnesota Department of Health)

Rising Adoption in Ambulatory Surgical Centres and Outpatient Settings

The shift towards outpatient surgical procedures has led to an increased adoption of smoke evacuation systems in ambulatory surgical centers (ASCs) and other outpatient settings. These facilities are performing a growing number of minimally invasive and laser-based procedures, which generate surgical smoke. To ensure patient and staff safety, as well as to comply with emerging regulations, ASCs are investing in compact and efficient smoke evacuation solutions. This trend is contributing to the expansion of the smoke evacuation systems market in the United States. Moreover, in February 2024, Olympus launched the OR-VAC Surgical Smoke Plume Evacuation System and the Telescopic Smoke Evacuation Pencil. The OR-VAC system offers variable filter life, compact design, and a three-port filter with tracking capacity and the Telescopic Pencil is extended up to 6.5 inches to eliminate the need for exchange electrodes.

Technological Advancements Enhancing Product Efficiency and Compliance

Technology is transforming the United States smoke evacuation systems market, with manufacturers introducing AI-powered filtration systems, smart sensors, and automated suction adjustments to improve OR air quality. Traditional smoke evacuation devices required manual adjustments, leading to inefficiencies. Now, intelligent systems can automatically regulate suction power based on smoke density, ensuring optimal performance without disrupting surgeries. Additionally, ultra-low penetration air (ULPA) filters are being integrated into modern systems to enhance the removal of harmful airborne particles. These advancements are particularly critical in high-risk procedures, such as laparoscopic and orthopedic surgeries, where smoke production is substantial. With the increasing adoption of robotic-assisted surgery, manufacturers are also developing compact, high-efficiency smoke evacuation units that integrate seamlessly with robotic platforms, ensuring compliance with evolving safety standards. As the United States healthcare system continues to embrace cutting-edge surgical technologies, demand for next-generation smoke evacuation systems is expected to rise. Medtronic offers a portfolio of Valleylab Smoke Evacuation Pencils, designed to capture smoke directly at the source during open procedures. These pencils are available in multiple formats to fit specific surgical needs, enhancing visibility and protecting surgical teams from the potential hazards of surgical smoke.

Future Market Scenario (2025-2033F)

The future of the United States smoke evacuation systems market looks promising, driven by increasing regulatory enforcement and advancements in surgical technology. With the Occupational Safety and Health Administration (OSHA) and other agencies pushing for stricter guidelines on surgical smoke management, hospitals and surgical centers are expected to adopt smoke evacuation systems at a higher rate. Additionally, innovations in filtration technology and portable systems will enhance efficiency and accessibility. The growing trend of outpatient and ambulatory surgeries will further boost demand for compact and cost-effective solutions. As awareness of surgical smoke hazards rises, the market is poised for steady expansion.

Key Players Landscape and Outlook

The key players in the market are significantly investing in the development of smoke evacuation systems and are utilizing strategies such as mergers, acquisitions, partnerships, and new product launches to improve their services and competitiveness. Such efforts will propel significant growth in the market, allowing large-cap industry players to increase their presence and, therefore, find new opportunities in this market.

In October 2023, Alesi Surgical (UK) received FDA 510(k) clearance in the United States for Ultravision2 System, the world's first surgical device to combine electrosurgery with advanced surgical smoke control in a single laparoscopic tool.