What Devices Received HUD Designation
As examples, the following devices, categorized by indications, have been designated HUD status:
| Indication | Device | Manufacturers | Year of HUD Designated | |
| Cardiology | Realheart® Total Artificial Heart | Scandinavian Real Heart AB | 2025 | |
| Pediatric Cardiology | EXCOR® Pediatric Ventricular Assist Device | Berlin Heart, Inc. | 2011 | |
| Orthopedics | Patient-Specific Talus Spacer | Additive Orthopaedics, LLC | 2011 | |
| Nephrology/Critical Care | Selective Cytopheretic Device | SeaStar Medical Holding Corp. | 2024 | |
| Spinal Trauma | Biopolymer Scaffold for Spinal Cord Injury | InVivo Therapeutics | 2012 | |
| Stem Cell Therapy | CliniMACS® CD34 Reagent System | Miltenyi Biotec | 2024 | |
| Burn Treatment | Epicel® Autologous Skin Graft System | Vericel Corporation | 2024 | |
| Neurovascular Surgery | FRED® Device for Intracranial Aneurysms | MicroVention Inc | not specified | |
| Ophthalmology | Argus II Retinal Prosthesis System | Second Sight Medical Products | not specified | |
| Gastrointestinal Oncology | Self-forming Magnet Anastomosis System | GI Windows | not specified | |
Two HUDs from China
Amid these global contributions to rare disease treatment, China has recently made its mark through Pulnovo Medical, a Shanghai-based company specializing in cardiopulmonary interventions. In January 2024, the FDA granted HUD designation to Pulnovo’s PADN Catheter and Generator system, marking the first known HUD approval for a Chinese medical device firm. This milestone not only underscores the growing sophistication of Chinese medtech but also highlights the global relevance of the HUD program.
Pulnovo Medical’s PADN system
The PADN system is indicated to treat pulmonary arterial hypertension (PAH), a progressive and life-threatening condition characterized by high blood pressure in the arteries of the lungs. Current treatments for PAH are often limited to pharmacological agents that provide symptomatic relief but do not alter the underlying pathophysiology. Pulnovo’s PADN system offers a novel interventional approach. It works by applying radiofrequency ablation to the pulmonary artery, thereby targeting the overactive sympathetic nerves that contribute to vascular constriction and remodeling. By interrupting these neural pathways, the device aims to reduce pulmonary artery pressure and improve right heart function.
The clinical development of the PADN system has been rigorous. Pulnovo conducted a series of trials, including a pivotal randomized, sham-controlled study completed in China in 2022, which demonstrated significant improvements in exercise capacity, hemodynamic parameters, and quality of life among patients who received the intervention. Encouraged by these results, the company has launched multicenter clinical trials across Europe, Southeast Asia, and South America to further validate the device’s safety and efficacy.
Pulnovo’s success with the PADN system is not just a triumph of engineering but also a regulatory landmark. The company received not only HUD designation from the FDA but also secured approval from China’s NMPA, as well as CE marking under Europe’s new Medical Device Regulation (MDR). Furthermore, the Centers for Medicare & Medicaid Services (CMS) in the United States granted a reimbursement code for the PADN procedure, signaling a high degree of institutional confidence in the technology.
Super Vision’s Implantable Ocular Neuromuscular Stimulator
China’s second HUD-designated device is the “Implantable Ocular Neuromuscular Stimulator” developed by Super Vision Technology. On June 19, 2025, Professor Lejin Wang, Chairman of Super Vision and Director of Ophthalmology at Peking University People’s Hospital, received FDA HUD designation and was approved to begin clinical procedures in the United States under the HDE framework to treat congenital nystagmus.
Congenital nystagmus (CN) is a hereditary eye disorder that typically appears between 3 to 6 months of age and persists throughout life. It significantly impairs visual function and appearance, severely affecting quality of life over the patient’s lifespan. Currently, no effective clinical treatments exist for CN, which is often considered incurable in ophthalmology. Super Vision’s product applies neuromodulation through personalized electrical stimulation of the extraocular muscles and nerves. It is a first-of-its-kind device and the only HUD-designated treatment for congenital nystagmus worldwide—offering hope to over 7 million patients globally who have long lacked viable treatment options.
