Brazil, United States, Chile, Colombia and, now, Japan. Eyer portable fundus camera, developed and produced by Phelcom, has just been approved in the country.
The Japanese regulatory process for entry of foreign technologies is considered one of the most challenging in the world. This is due to the various players accessed during the procedure, such as the DMAH – Designated Marketing Authorization Holder (legal representative), RCB (third-party certification organization), Foreigner Manufacturer and PMDA (regulatory agency), besides the specific certification flows for each product class. The language barrier was another difficulty, since all the reference documentation was in Japanese.
José Roberto Santiciolli Filho, coordinator of Product Development in Phelcom Technologies, explains that the certification process started in the end of 2021, when the Japanese Ministry of Health, Labour and Welfare approved the company as a Foreign Manufacturer. At this stage, all the manufacturing infrastructure and Quality Management system were evaluated.
“After that, we developed the technical dossier of the product, according to PMDA standards and submitted all the technical and quality documentation to third-party impartial evaluation, for then receiving the certificate”, explains Santiciolli.
During the certification process, Phelcom counted on the support of its investor, Allm Inc., headquartered in Japan, for interlocution with local agents. In November this year, Eyer received the medical device certification with the number 304AIBZI00005000.
Phelcom Eyer
Phelcom Eyer is a handheld fundus camera that works coupled to a smartphone. It carries out high-quality fundus exams in a few minutes, without the need of pupil dilation.
Integrated to an online platform, EyerCloud, data are automatically sent and can be analyzed by a specialist from anywhere in the world. That is, it makes remote diagnosis possible.
More than that, the embedded artificial intelligence provides intelligent functions to help medical diagnosis and capture of retinal exams. On the other hand, the portable technology of accessible value democratizes the access to retinal exams. The device is around six times cheaper than a conventional tabletop fundus camera, which still demands integration to a computer.
Learn about the advantages:
CONNECTIVITY
The device is naturally connected, since it is attached to the smartphone. Therefore, it eases cloud sharing and access of exam data in the Eyer Cloud system.
NON-MYDRIATIC
Eyer allows to carry out retinal exams anywhere, without needing eye drops for pupil dilation. Thus, the patient feels more comfortable and the exam is faster.
LOW COST
Portability and reduced size grant Eyer a lower cost in relation to traditional fundus cameras. Even with the cutting-edge technology applied in the device production.
Currently, more than 1.2 million people have been examined and around 10 million exams were carried out in Brazil, United States, Chile and Colombia.
Eyer is also in the certification process in Mexico. Furthermore, a new Phelcom product is being approved in Brazil and in the United States.
“The favorable result of the process in Japan demonstrates we are on the right track to democratize access to ophthalmology. We are very happy to make available to one more country an innovative solution that will make a difference in the struggle against blindness in the world”, highlights Santiciolli.
In early 2019, a colleague introduced the Phelcom Eyer smartdevice to ophthalmologist and retina specialist Gustavo Melo. Coupled to a smartphone, the device carries out high-quality fundus exams, in few minutes and without need of pupil dilation. It connects to an online platform, the Eyer Cloud, which allows remote diagnosis and assures safety to data stored in the cloud.
“I invested in this technology because I believed it would be a device that could revolutionize screening and diagnosis of diabetic retinopathy in the population not usually monitored with due regularity in eye offices,” he says.
Currently, Melo has performed more than two thousand exams with his two devices. One of them is used in an endocrinological clinic for screening patients with diabetes. “Those who have any changes are referred for detailed ophthalmic evaluation. Those with normal rates are reviewed annually, ” he explains.
Gustavo Melo, Ophthalmologist
The second Eyer is used to screen diabetic retinopathy in public health units in Aracaju (SE) and cities in the countryside, in voluntary actions through partnership with public managers. “The purpose is to be a continuous way to carry out early detection and awareness campaigns about the disease,” he says.
More than that, Melo reveals that he, in partnership with the ophthalmologist Fernando Malerbi, is developing a project to screen and treat diabetic retinopathy in the population of 13 inhabitants from Sergipe hinterland. The action will be a partnership of the American NGO Retina Global and Phelcom Technologies, startup responsible for Eyer.
“I think Eyer is a revolutionary milestone in primary care because it could change the way health managers prevent blindness due to diabetic retinopathy,” he says. For the ophthalmologist, using the equipment also in the Brazilian Unified Health System should reduce the evaluation cost per patient.
Phelcom Eyer
Image made by ophthalmologist Gustavo Melo with Eyer.
About the advantages of the technology, Melo reports that the easy handling, the high-quality images and the excellent cost-effectiveness. Regarding the EyerCloud online platform, the doctor points out the very user-friendly interface and extremely fast processing. “Perhaps this tool is one of Eyer’s best features,” he says.
Phelcom Eyer is integrated with Eyer Cloud and enables storing and managing patient exams. All data the equipment captures are automatically synchronized to the system, allowing a totally safe upload to the cloud.
Among the main functionalities are the possibility of sharing patient information with more than one clinic and visualize them in the same platform; locate patients by name or exam date; and create report templates from pre-made models available in the system.
In case of no internet access during the exam, images remain stored in the device and are sent to the cloud as soon as a connection is available.
The tool may be accessed in the device itself or via cellphone, tablet or computer.
Image made by ophthalmologist Gustavo Melo with Eyer.
About Phelcom’s slit lamp support, which allows attaching Eyer, the ophthalmologist says it greatly eases examinations performance by keeping the device static. And, with the new coronavirus pandemics, it also avoids contact of the operator’s hand with the patient’s skin.
“Eyer is a real game changer in the way diabetic retinopathy is detected and treated, as well as other retinal diseases,” Melo concludes.
Phelcom Technologies
Eyer is the first equipment of Phelcom Technologies, startup that unites technology and health, headquartered in São Carlos (SP). It manufactures wearable handheld devices with internet connection, aiming to democratize access to healthcare, offering better services, with a compact equipment, to more people.
Image made by ophthalmologist Gustavo Melo with Eyer.
For one of the most renowned Ophthalmologists in Brazil, technology is fundamental in primary care because it allows the detection of eye diseases in a faster, simpler and cost-effective way.
For 20 years, Ophthalmologist Rubens Belfort Jr. has been looking for efficient ways to use telemedicine to diagnose ocular diseases. “Initially, the devices were very expensive and heavy, which made it very difficult, especially in Brazil, to use teleophthalmology,” recalls Belfort.
However, in the last few years, more modern, practical and cheaper models have appeared on the market. One of them is the smartdevice Phelcom Eyer, which is attached to a smartphone, performs fundus exams in a few minutes and without the need for pupil dilation. In addition, it allows the photograph to be sent and stored on an online platform for remote evaluation.
Through the scientific community, Belfort found out about the equipment still in the development phase. “I accompanied the whole process and helped in the improvement of this technology that revolutionizes the possibility of expanding the diagnosis of ophthalmological diseases. And not only in Brazil, but in all countries, since the lack of financial resources is widespread,” he says.
However, the doctor has never had any commercial relationship with the company that created the device, the startup Phelcom Technologies.
Belfort believes that the device has significant advantages over traditional retinal cameras, such as portability, easy handling, high image quality and extremely affordable price. “This type of technology is very important not only in Ophthalmology, but also for other specialties such as Endocrinology, Geriatrics, and Rheumatology. In addition, medical students need to learn how to use this model of device and retire the old one, which has existed for more than 150 years and is totally outdated”, he points out.
Vision Institute
Since 2019, the Eyer is used daily by Belfort’s team in primary care of SUS patients at the Paulista Institute for Studies and Research in Ophthalmology (IPEPO), popularly known as the Vision Institute, in São Paulo. The entity is a non-profit, philanthropic organization linked to the Ophthalmology Department of the Paulista School of Medicine, Federal University of São Paulo (Unifesp). Belfort has been a full professor in the Department of Ophthalmology since 1991.
The Vision Institute provides medical services through diagnosis, clinical and surgical treatments in assistance and didactic projects. Currently, it assists approximately 80 thousand SUS patients with the help of teleophthalmology. With quick training, the professionals of the area, such as technicians, nurses and students, under the supervision of doctors, perform the exams. So far, more than 80 thousand exams have been done to detect diseases such as glaucoma, cataract, diabetic retinopathy, maculopathies, toxoplasmosis, and others.
“Our experience shows that for every 1,000 patients, 850 do not have a disease that requires referral and treatment. In fact, 85% need glasses or have symptoms of dry eye or less dangerous problems. Therefore, through this technology, we are able to diagnose and already refer these 15% for the correct treatment. This provides significant savings in time and resources for the medical system and for the patient as well. Everybody wins,” points out Belfort.
In this sense, the Ophthalmologist believes that the use of Eyer in primary care is fundamental, because it empowers professionals to detect, in a faster and simpler way, ocular diseases. “That is the future. Even more: in a few years, the patient will be able to examine himself. This is the path that this technology is allowing”, he reflects.
Social actions and research
Belfort also uses Eyer in medical actions and research at Unifesp. “We use it in the Amazon Eye Oncology Center, in Manaus, and as of this year, we will also use it in our advanced campus in Rondônia, in partnership with the University of São Paulo,” he says.
In relation to research, the most recent one counted on Eyer in the detection of the new coronavirus (SARS-CoV-2) in retinal lesions. The discovery is unprecedented. The work was carried out in partnership with the Federal University of Rio de Janeiro (UFRJ) by scientist Wanderley de Souza and published in the journal JAMA Ophthalmology.
The researchers, led by Belfort, photographed the fundus of a patient’s eye with Eyer. “The image quality is very good. It’s certainly not inferior to other much more expensive models. It’s probably even better than these. The quality is so good that the photographs taken in the research are accepted in the best ophthalmology journals in the world,” says Belfort.
A research carried out in two referral centers for covid-19 in Rio de Janeiro (RJ) identified alteration in the retina of patients hospitalized in serious condition. The study occurred in May 2020, in the clinical hospitals Mario Lioni and from Jacarepaguá, and was published in the journalPlos One in December, the same year.
The work was also one of the first to discover retinal damage in critical cases of the disease.It is noteworthy that other Brazilian studies, from the ABC School of Medicine (FAMBC) and the Federal University of São Paulo (Unifesp) , published shortly before, also detected retinal alterations.
Researchers used the smart device Phelcom Eyer to carry out the retinography in 47 eyes of 25 patients. Coupled to a smartphone, the device carries out high-quality fundus exams, in few minutes and without need of pupil dilation.It connects to an online platform, the Eyer Cloud, which allows remote diagnosis and assures safety to data stored in the cloud.
“Our study showed that, from the patients hospitalized in serious conditions for covid-19 clinical stabilization, 12% presented some finding”, says one of the doctors responsible for the work, Rafael Lani Lozada, ophthalmology resident in Gamboa Hospital (RJ).
A 35-year-old man from the mentioned sample, who had diverse clinical complications during hospitalization, manifested bilateral nerve fiber layer infarctions and micro-hemorrhages in the papillomacular bundle; another man, 56 years old, who needed to undergo full anticoagulation, had a unilateral “flame-shaped” hemorrhage; and a third man, 49 years old and hypertensive, presented discrete and bilateral retinal micro-hemorrhages.
To Lozada, the study shows retinal alterations may occur in severe covid-19 cases.“They were probably secondary to clinical intercurrences or comorbities rather than a direct damage by SARS-CoV-2, since it was not possible to correlate the problem directly to the virus.Thus, the retinal finding may be important and easily accessible markers of therapeutic interventions, as well as sentinels of neurological and systemic diseases during the pandemic”,
The doctor highlights that new studies with more patients are necessaryto establish statistic correlations between covid-19 and retinal lesions.
Phelcom Eyer
Louzada states that Phelcom Eyer was essential to the project, since the study, as a base, evaluated hospitalized patients in isolation, with a highly contagious and little studied virus.“Using a clean easy-to-handle portable device made it possible for us to step further in the search for a better comprehension of this disease, that afflicts humanity”, he observes.
The researcher also highlights other advantages on the equipment: short learning curve, quick image backup and a possible thorough analysis from any computer with internet access.“Not to mention that the fundus exams are very beautiful, with a great resolution and the color photos are automatically duplicated with red-free images”, he analyzes.
Beyond the pandemic
Lozada also highlights that the technical ease of retina evaluation with Eyer opens new horizons to triage exams, not only in the present pandemic context, but also for other ophthalmological diseases. “The possibility to obtain retinographies in a portable, easy and practical way, through an accessible image backup, allowing their remote careful study, is fundamental for advances in ophthalmological researches and better diagnostics”, he finishes.
During the XIX Caipira Congress, in June 2029, in Bauru (SP), the ophthalmologist Flávio Augusto Schiave Germano met the newly released smart device Phelcom Eyer.
Coupled to a smartphone, the device carries out high-quality fundus exams, in few minutes and without need of pupil dilation.It connects to an online platform, enables remote diagnosis and assures safety to data stored in the cloud.
Some months later, the doctor looked for similar devices in the annual congress of the American Academy of Ophthalmology.“But the national equipment, from São Carlos, proved to be superior both in image quality and design.It is lightweight and portable – handling is quick and intuitive, which makes it easy to use in any situation”, states Germano.
In September, 2020, the ophthalmologist acquired the smart device. He currently uses it every day in his office and in the medical residence service in the Center of Excellence in Ophthalmology (CEO), in Bauru (SP).
In the last six months, he carried out more than 1,1 thousand exams, totaling around 5,5 thousand images.As the service of medical residence works with the glaucoma ambulatory, images are mostly from the optic disc and the surrounding fibers and of the visual field.
Phelcom Eyer
Germano highlights two features of the Phelcom Eyer.“it is not necessary to carry out the exam under mydriasis, which gives more safety to patients with narrow-angle glaucoma*, and it is possible to correct the degree of myopia and hyperopia up to 20 D” he highlights.
Other positive aspects evaluated by the doctor are the fast patient registration, fast imaging and the photo resolution. “It is great and, even when exams are sent to report, the image quality remains high”, he states.
The ophthalmologist sees a great cost-effectiveness in the device. “It is an investment that brings various benefits: it helps the academic department of medical residence, patients feel safer with the regular follow-up through the retinographies and the description in medical records turns more consistent and reliable”, he points out.
Eyer Cloud
Phelcom Eyer integrates to Eyer Cloud, an online platform that enables storing and managing the patient exams. All data the equipment captures synchronize with the system automatically, so that they upload to the cloud with complete safety.
“Eyer Cloud is simple, modern and intuitive,” says Germano. Main features include the possibility of gathering information of a single patient from more than one clinic and visualize them in the platform; searching patients by name or exam date; and creating report templates from pre-ready models that the system provides.
In case of no internet access during the exam, images remain stored in the device and are sent to the cloud as soon as a connection is available.
The tool may be accessed in the device itself or via cellphone, tablet or computer.
Slit lamp
Phelcom slit lamp support. Note: This photo was taken before covid-19 pandemic.
About Phelcom slit lamp support, which enables attaching Eyer to a tabletop, Germano says it eases the documentation by providing agility and optimal alignment between the patient face and the fundus camera.
“The device also offers the advantage of not needing to directly touch the eyelids and eyelashes of patients, which guarantees more safety during the pandemic”, he notes.
Phelcom Technologies
Eyer is the first equipment of Phelcom Technologies, startup that unites technology and health, headquartered in São Carlos (SP). It produces portable devices, connected and wearable, aiming to democratize access to healthcare, offering more from less and to more people.
“Phelcom can synthesize what is best in startups: agility in the communication, highly effective in technical support and innovation in favor of patients. Undoubtedly, Eyer is a great investment in a diagnostic toolbox increasingly important to the ophthalmologic practice”, evaluates Germano.
Algorithm was runned during the Itabuna Diabetes Campaign and helped the health professionals to screen and refer more than 820 Diabetic Retinopathy patients. The solution will be released to the market still in 2021.
Phelcom fundus camera, the Eyer, has been used in Itabuna Diabetes Campaign several times, but this year it was different. In the captured images was runned an Artificial Intelligence algorithm developed by Phelcom, where it could be identified with a good sensitivity and specificity patients with Diabetic Retinopathy (DR) condition.
Exam being performed using the Eyer during the Itabuna Diabetes Campaign.
The sensitivity was 97.8%, what means a high algorithm capacity in identifying patients with DR. When it was analyzed the specificity, the number reached was 61.4%, that indicates the percentage of health patients that the algorithm confirmed that really was healthy. The AUC, Area Under the Curve, was 0.89 and it shows in this scenario a high rate of the algorithm assertivity to refer just DR patients to in person consultation and not the healthy ones.
Sensitivity was high when indicating more than mild cases, the ones where the patient needs to undergo a medical treatment with a specialist – the mild ones are usually monitored at every given time period. Besides specificity was not in a higher score as sensitivity, it was a good result considering the algorithm was not only detecting DR, but other retinal alterations like hypertensive retinopathy, aged macular degeneration (AMD), toxoplasmosis, among others, while the physician was focused on this project to detect just DR cases.
Examples of the algorithm heath map enhancing the colours in regions where it was detected retinal alterations and pointing the percentage of the Retinal Alteration Score. Source: Phelcom.
The article, published in the Journal of Diabetes Science and Technology, points out that screening patients on diabetic retinopathy could be one of the most cost-effective initiatives on diabetes care, but in several scenarios there is insufficient health care structure and resources in terms of funding, trained health care human resources, and facilities.
Eyer is a portable, connected and affordable device to perform posterior and anterior eye exams, these characteristics were highly suited to capture the images during the health campaign. As the equipment offers high quality images, to run an artificial algorithm in the images was a natural step, as it could help the health professionals screen more than 820 patients.
Phelcom has been developing this solution during the past few years, it still has no commercial name, but it will be available on the market still in the first semester of 2021. José Stuchi, CEO at Phelcom, says the company aims to develop new artificial intelligence services that will be aggregated to the EyerCloud, Phelcom’s cloud system to store patients medical records. “We are sure that this new algorithm and other ones we are working on will help physicians to diagnose those challenging conditions that sometimes are difficult to be identified to the unaided eye”, he stands.
When working with scarce resources, whether human, financial or material, Phelcom is creating solutions to break down barriers to eye care access, enabling health professionals to reach patients in different scenarios and regions.
The full publication and results are available in the original article, access: https://journals.sagepub.com/eprint/H58YCATDBNT5YRZYAXKW/full
Português 
Español 
English 
