PVmed Contouring Software Receives FDA 510(k) Clearance, Accelerating Global Expansion
2021Year12Month3On [date], products under Baishi MedicalPVmed Contouring SoftwareApproved by the U.S. Food and Drug AdministrationFDA510(k)Certification Achieved: Another Milestone on the Journey to the International Market!
As the aging of the population intensifies, the number of cancer patients worldwide continues to rise. According to the 2020 Global Cancer Statistics released by the International Agency for Research on Cancer (IARC), there were 19.3 million new cancer cases and 10 million cancer deaths. Based on existing cancer-related data estimates, the IARC predicts that there will be approximately 28.4 million new cancer cases globally in 2040, representing a 47% increase from the 19.3 million cases recorded in 2020.
Radiotherapy, short for radiation therapy, is a treatment modality that uses ionizing radiation to target and destroy cancerous cells, thereby achieving local tumor control and improving survival rates. It has been proven highly effective in local tumor control and can help increase patients’ five-year survival rates to some extent. When curative outcomes are unlikely, radiotherapy can also serve as a palliative measure to alleviate cancer-related symptoms. Statistics indicate that approximately 65%–75% of cancer patients require or may benefit from radiotherapy during the course of their treatment.
Since the discovery of X-rays in 1895, radiotherapy has rapidly developed worldwide and, together with surgery and chemotherapy, is recognized as one of the “three pillars” of malignant tumor treatment. It is currently considered applicable to a wide range of cancers, including solid tumors and leukemia, and serves as a foundational treatment option for various localized tumors such as lung cancer, breast cancer, and head and neck cancers. This underscores the critical importance of radiotherapy in oncology care.
The formulation of radiotherapy protocols, the training and education of relevant medical personnel involved in each stage of the radiotherapy workflow, the continuous improvement of various radiotherapy techniques, and the application of equipment and auxiliary devices used in the process are all aimed at achieving precise radiotherapy with high accuracy, high efficacy, and minimal damage.
As the ancients said, “The target must be established first, and the arrow follows accordingly.” This principle also applies to the entire radiotherapy process. Only with precise radiotherapy target volumes can the benefits of radiotherapy be maximized while minimizing damage.
It is well known in the industry that high-precision delineation of tumor radiotherapy targets is a prerequisite and key technology for the successful implementation of precision radiotherapy. In the past, clinical practice primarily relied on physicians to manually delineate the target volumes. A single patient might require dozens or even hundreds of medical images prior to radiotherapy, necessitating 3–5 hours of a physician’s time to complete the entire delineation process. This procedure is complex and inefficient.
Accurate target volume delineation requires radiation oncologists to possess profound and solid knowledge in human anatomy, diagnostic imaging, oncology, and radiobiology, along with extensive clinical experience. Furthermore, the accuracy of target volume delineation is highly dependent on the physician’s experience; such subjective judgment can, to a certain extent, affect the precision of radiotherapy planning and treatment efficacy.
As an intelligent auxiliary tool, PVmed Contouring Software is designed to address the primary challenge in the tumor radiotherapy workflow by precisely delivering adequate dose to the target volume while minimizing damage to surrounding normal tissues, thereby improving tumor control rates, prolonging survival time, and enhancing quality of life. After years of clinical validation, it has been proven to fully meet clinicians’ needs, efficiently reducing the department’s daily workload while elevating the overall contouring proficiency, thus earning widespread acclaim.
Baishi Medical possesses comprehensive expertise in product R&D, commercialization, and marketing. Its core technical team hails from world-leading medical imaging laboratories, and the company remains committed to addressing clinical pain points through its products and empowering physicians with technology. Leveraging advanced algorithms, Baishi Medical has developed multifunctional auxiliary software that deeply integrates into every stage of the radiotherapy workflow, covering application scenarios such as image visualization, target volume delineation, treatment planning, plan evaluation, dose assessment, and therapeutic efficacy analysis. This continuous innovation further solidifies Baishi Medical’s leadership and core competitiveness in the field of “intelligent” cancer therapy.
While focusing on clinical needs and meticulously refining its products, Baishi Medical is also actively promoting the commercial implementation of its products.and has successively obtained registration approvals from the National Medical Products Administration (NMPA) for multiple Class II and Class III medical devices over the past several years, with numerous products transitioning from clinical validation to commercialization.
The FDA is widely recognized as one of the largest food and drug regulatory agencies in the world, exerting a profound influence both in the United States and globally. Obtaining FDA authorization and certification is a prestigious honor and a mark of assurance pursued by many international manufacturers.
As a rapidly growing technology company specializing in AI-driven oncology treatment solutions, Boshijian Medical has become a long-term partner of several top-tier international medical device companies. Through research collaborations, it has successively provided services to cancer patients in overseas regions such as Singapore and East Africa. With this recent FDA 510(k) clearance, Boshijian Medical’s commercialization credentials have officially expanded from the domestic market to the global stage, meaning its products will benefit a larger number of cancer patients worldwide. Leveraging this momentum, Boshijian Medical will further expand its business footprint in overseas markets.
Currently,Baishi Medical’s products have been deployed across relevant departments, including radiation oncology and thoracic surgery. Its core business encompasses three major segments: intelligent comprehensive solutions for radiotherapy, intelligent comprehensive solutions for surgical procedures, and intelligent cancer centers., it provides comprehensive, end-to-end AI-assisted treatment solutions covering multiple diseases and multimodalities for healthcare institutions, medical device manufacturers, and technical service providers worldwide. Its business scope now covers more than 20 provinces and municipalities in China as well as select international markets, having cumulatively served over 120,000 clinical patients with tumor radiotherapy and surgical treatment services.
Over the past few years of AI-empowered healthcare, numerous players have flocked to the sector. However, the high barriers inherent in the healthcare industry, coupled with the volatile and complex landscape of scientific and technological advancement, have created thresholds in the medical AI industry that are not easily surmounted by other sectors. After this period of intense competition and consolidation, capital investment has begun to rationalize. It is undeniable that medical AI boasts extensive market demand and diverse business trajectories, and its efficacy is driving digital healthcare into a new wave of innovation.
Riding the Crest, Braving the Waves—From boldly entering the medical AI arena in its early stages and rapidly emerging as a leader in AI-driven oncology treatment, to diligently deepening its expertise in cancer care and achieving repeated successes, Bosh Medical has always remained unafraid of challenges, committed to pioneering breakthroughs in medical innovation.
In August 2021, BAI Vision Medical completed its Series A financing round. The nearly RMB 100 million raised, led by existing shareholder Xenuo Chentu and strategic investor Philips, with follow-on investment from Gaolue Capital, will be applied to accelerate the commercialization of the company’s intelligent radiotherapy products, support the research and development of new intelligent surgical planning products, and further enhance BAI Vision Medical’s sales network.
In the future,Baishi Medical will fully integrate and synergize high-quality channel resources both domestically and internationally, accelerate its commercialization strategy, and comprehensively empower the field of AI-driven oncology treatment., to provide more refined, precise, and personalized intelligent technologies and services to a broader range of cancer patients across different regions both domestically and internationally, thereby promoting the development of the healthcare industry.