All-Digital PET Industry Ecology

The digital positron emission tomography (PET) innovation technology system, which gradually evolved from the Multi-Voltage Threshold (MVT) sampling method, has driven the development of many fields, including key materials, core devices, electronics, intelligent algorithms, and industry standards, forming a new PET industry ecology characterized by modular hardware and intelligent software. In 2010, the world's first All-Digital PET scientific instrument, based on the MVT method, was successfully developed and showed an obvious spatial resolution advantage. With the modular characteristics of the All-Digital PET’s detector, it has successively developed digital PET scientific instruments with different apertures, different fields of view (FOV), and different geometric structures for small animals, large animals, primates, and plants, and has been put into various scientific research applications. In 2015, the world's first All-Digital PET medical device prototype for human scanning was successfully developed. In the following 7 years, several clinical All-Digital PET products have been developed and put into the market. These All-Digital PET products break the fixed architecture of conventional whole-body scanning in the past and use modular digital detectors to build various medical devices, such as site-dedicated PET systems, plug-in PET components, wearable PET, and proton PET. It has helped promote the rapid expansion of PET applications from tumor diagnosis to new application fields such as nervous system diseases, unexplained fever, and proton precision treatment. The vigorous development of All-Digital PET ecology has also brought innovation to the industrial division of labor. The new scintillation crystal materials, the new silicon photomultiplier (SiPM), and the modular PET detector are developing independently and rapidly, forming their own standardized component or interface. The synchronous progress of upstream and downstream technologies has promoted the development of the entire PET industry chain and innovation chain. With the rapid development of All-Digital PET, the proposal of a variety of PET digital technology routes has also put forward new challenges to industry technical standards and regulatory systems, such as technical requirements for the digitization of PET medical devices and the registration guidelines that have been updated and developed simultaneously. This paper reviewed the dynamic progress of All-Digital PET in scientific instruments, medical devices, the industrial chain, and regulatory science in the past 20 years and looked forward to the future ecological development of All-Digital PET.