Pulsecare Medical Announces NMPA Approval of NxPFA™, the World's First Nanosecond PFA System, Ushering in the PFA 3.0 Era

SHENZHEN, China, Aug. 4, 2025 /PRNewswire/ -- Pulsecare Medical, a pioneer in cardiovascular intervention technologies, announced that its innovative NxPFA™ nanosecond pulsed field ablation (ns-PFA) systemhas received marketing approval from China's National Medical Products Administration (NMPA). As the world's first third-generation ns-PFA system utilizing high-voltage nanosecond pulses for pulmonary vein isolation (PVI) in atrial fibrillation (AF) treatment, this breakthrough marks the dawn of the PFA 3.0 era and represents the innovative capabilities of Pulsecare Medical in cardiovascular multimodal therapy.

 The World's First Commercially Approved Nanosecond PFA

PFA has revolutionized AF treatment through its tissue selectivity, safety, and procedural efficiency. Yet, early-generation systems using microsecond pulses face key challenges—excessive muscle stimulation, reliance on general anesthesia, and risks like hemolysis and gas embolism—that limit broad adoption.

As the world's first and only commercially available nanosecond PFA system, NxPFA™ represents the "Next of PFA" generation. It combines the MaviPulse™ high repetition frequency ns-PFA console with the InteShot™ basket-shaped catheter to deliver irreversible electroporation of cardiomyocytes via high-voltage nanosecond pulses, effectively overcoming key limitations of microsecond PFA (μs-PFA) technologies:

Significantly reduces neuromuscular stimulation, enabling procedures under conscious sedation, improving patient comfort and lowering anesthesia risks;

Combines nanosecond pulses with a basket-shaped catheter to ensure optimal electrode-tissue contact and high success rates, while shortening procedural time;

Substantially lowers intravascular gas formation, lowering the risk of stroke or systemic embolism;

Minimizes erythrocytic damage and post-procedural bilirubin elevation, reducing potential kidney injury.

NxPFA™ Demonstrates Outstanding Efficacy and Safety

The NxPFA™ system has been clinically validated through the SCENA-AF multicenter registration trial, which enrolled 166 patients with paroxysmal atrial fibrillation. The data has been acknowledged by NMPA and will soon be published in an academic journal. Key outcomes include:

100% acute pulmonary vein isolation success rate

88.27% one-year treatment success rate (PPS)

No device-related serious adverse events reported

Over 92.8% of procedures completed under conscious sedation, with excellent intraoperative tolerance.

These results confirm NxPFA™'s strong performance in efficacy, safety, efficiency, and patient comfort. It remains the only PFA system globally to achieve one-shot PVI under conscious sedation with high success, marking the debut of the third-generation nanosecond PFA era.

"NxPFA™'s approval is not only a major milestone for Pulsecare Medical but also a transformative breakthrough for cardiac electrophysiology. With NxPFA™, we address critical clinical challenges and look forward to collaborating with global EP experts to shape the future of arrhythmia treatment—delivering smarter tools to physicians and safer, more effective, more comfortable therapies to patients," said Dr. Javen Tan, CEO of Pulsecare Medical.

About PulseCare Medical

Founded in July 2021 and headquartered in Shenzhen, Pulsecare Medical is dedicated to the innovation and development of cardiovascular multimodal therapeutic devices. Backed by a rare cross-disciplinary team combining clinical and engineering expertise, the company is building a next-generation energy platform for interventional therapies. Pulsecare offers total solutions for cardiac electrophysiology and hypertension interventional therapy, aiming to lead in minimally and non-invasive treatments.

** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **

Pulsecare Medical Announces NMPA Approval of NxPFA™, the World's First Nanosecond PFA System, Ushering in the PFA 3.0 Era

CHANGSHA, China, Jan. 15, 2026 /PRNewswire/ -- Zoomlion Heavy Industry Science & Technology Co., Ltd. ("Zoomlion"; 1157.HK) is driving a new wave of intelligent transformation by integrating AI with construction machinery, the industrial internet, big data, and cloud computing. Its full-chain AI system spans smart products, manufacturing, management, and embodied-intelligence robotics, reshaping the company into a fully digital and intelligent enterprise. Zoomlion is also scaling humanoid robotics as its "third growth curve," backed by proprietary hardware-software integration capabilities.

Zoomlion's full-chain AI application system covers four major pillars, namely, AI plus construction machinery, AI plus intelligent manufacturing, AI plus intelligent management, and AI plus embodied-intelligence robots. At Zoomlion Smart City, 12 smart factories and over 300 smart production lines, including 20 lights-out lines, operate as an end-to-end intelligent manufacturing system. In the AI plus intelligent manufacturing domain, processes such as cutting, welding, machining, painting, and assembly are fully connected to the industrial internet platform. This allows unified management of over 100,000 material types and intelligent manufacturing of over 400 products. 

AI-driven scheduling and optimization enable the park to produce an excavator every six minutes, a scissor lift every 7.5 minutes, a concrete pump truck every 27 minutes, and a truck crane every 18 minutes, marking a breakthrough in large-scale, multi-variety, small-batch agile manufacturing. Zoomlion also applies AI across R&D, production, sales, service, and supply chain management. For customer service, the Company has launched a voice-based AI expert diagnostic system with over 95 percent accuracy, enabling remote fault identification, rapid troubleshooting, and 24-hour technical support. 

Since 2024, Zoomlion has expanded into embodied-intelligence humanoid robotics, leveraging its full-stack self-development capabilities. Dozens of humanoid robots are now deployed in factory logistics, loading and unloading, pre-assembly, and quality inspection, forming early productivity use cases. Supported by a self-built training ground with over 100 workstations and large-scale industrial datasets, Zoomlion enables rapid iteration of human-robot collaboration. All humanoid and industrial robots are connected to the Zhongke Yungu Embodied Intelligence Platform, which integrates data, training, simulation, and OTA deployment into a closed loop, powered by a national supercomputing center with 59P GPU computing capacity and tens of thousands of distributed nodes.

Beyond humanoid robotics, Zoomlion is developing a wider range of specialized robots for firefighting, mowing, construction, and agriculture. With deep integration across hardware, AI models, and real-world scenarios, the company is positioning embodied intelligence as its next major growth engine.

** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **

Zoomlion Advances Intelligent Manufacturing with Integrated AI and Embodied-Intelligence Robotics