Known as a reference in innovation, the country has one of the most challenging regulatory processes for foreign technologies in the world. The handheld fundus camera, developed and produced by Phelcom Technologies, is now commercialized in five countries.
Phelcom Technologies has conquered one more international market. Now, Japan took its turn to receive Eyer, a non-mydriatic handheld fundus camera, coupled to a smartphone, that carries out high-quality retinal exams in a few minutes.
“We are very proud to have our equipment sold in a country known as a reference in technology and innovation”, states the company CEO, José Augusto Stuchi.
The Japanese regulatory process for entrance of foreign technologies is considered one of the most challenging in the world. This is due to the various players accessed in the procedure, such as DMAH – Designated Marketing Authorization Holder (legal representative), RCB (Regional Certifying Body), PMDA (regulatory agency); as well as specific certification workflows for each product class. The language barrier was another difficulty, since the whole reference documentation was in Japanese.
José Roberto Santiciolli Filho, Product Development coordinator at Phelcom Technologies, explains that the certification process started by the end of 2021, when the company was approved by the Ministry of Health, Labor and Welfare of Japan (MHLW) as a Foreign Manufacturer. All the manufacturing infrastructure and the Quality Management system were evaluated by then.
“After that, we developed a technical dossier of the product, according to PDMA standards, and submitted all the technical and quality documentation to a third-party unbiased evaluation to receive the certificate”, explains Santiciolli.
During this process, Phelcom counted on the support and partnership of Allm Inc., an investor based in Japan, for interlocution with local agents. Last November, Eyer received the medical device certification no. 304AIBZI00005000.
Eyer in the USA, Colombia and Chile
More than Brazil and Japan, Eyer is present in Chile, Colombia and the United States – where Phelcom also has an office in Boston. “This new unit confirms the internationalization movement of the company, started a year ago, and shall support the offer of equipment in the North-American market”, observes Stuchi.
The CEO highlights that physical presence in the United States confirms Phelcom’s availability to work for making eye exams simpler, connected and intelligent, without borders. “In 2022, we took part, as expositors, of the main ophthalmology congresses of the United States, as the American Society of Retina Specialists Annual Meeting, in New York, and the American Academy of Ophthalmology, based at Chicago. American professionals have accepted Eyer very positively”, states Stuchi.
In March 2023, the company has also been at Vison Expo East, a commercial exposition in New York. This month, it is taking part of ARVO (April 23 to 27), in New Orleans, and ASCRS (May 5 to 8), in San Diego.
For Stuchi, being a Brazilian company which operates in important markets worldwide is a pride and great responsibility to Phelcom. “It is certain that internationalization widens our potential to act. However, it also increases our commitment to offering excellent quality products that really contribute to the professional practice”, he complements.
Phelcom Eyer
Phelcom Eyer is a handheld fundus camera that works coupled to a smartphone and carries out high-quality retina exams, in a few minutes, without need of pupil dilation.
The technology supports the diagnosis of over 50 diseases, such as glaucoma, cataract, diabetic retinopathy, DMRI, retinoblastoma, hypertensive retinopathy and ocular toxoplasmosis. Currently, more than 10 million exams have been made in Brazil, United States, Chile and Colombia. The portability and the more accessible value of the technology democratize the access to retinal exams. Because it costs approximately six times less than a conventional tabletop fundus camera, which still needs to be integrated into a computer.
About Phelcom
Phelcom Technologies is a Brazilian medtech, headquartered in São Carlos, São Paulo. Its history started in 2016, when three young researchers – a physicist, an electric engineer and a computing engineer (PHysics, ELetronics, COMputing) – created a handheld fundus camera based in technology embedded in a smartphone.The interest of Diego Lencione, a company partner, on visual health gave birth to the first equipment project. His brother has a condition that severely compromised his retina and vision since childhood.
In 2018, Phelcom launched its first product in the market: Eyer handheld fundus camera. Nowadays, the technology has already reached more than 1.2 million people all over Brazil and other countries where it is present.
Ophthalmologist Balamurali Krishna Ambati, known as “Bala” Ambati, is the youngest doctor in the world, according to the Guiness Book of Records. At the age of 17, he graduated in medicine in Mount Sinai School of Medicine, in New York (USA), in 1995.
After that, he did residency in ophthalmology at Harvard University, where he developed strategies to reverse corneal angiogenesis. Since then, he has helped various non-profit organizations all over the world, such as ORBIS – Cooperation and Development and Sight for the Sightless, which acts to combat blindness in the Indian countryside.
He received various important awards for his work, such as the Gold Humanism Award and the Troutman-Veronneau Prize. Nowadays, he leads the clinic Pacific Clear Vision Institute, in Eugene, in the state of Oregon (USA).
For six months, the ophthalmologist has been using the Eyer Portable Fundus Camera in the clinic, on a daily basis. The technology works coupled to a smartphone, to carry out high-quality retinal exams in a few minutes, without need of pupil dilation.
“We acquired the Phelcom Eyer camera about 6 months ago and have been incredibly pleased with it. Its image quality, easy to use and easy to learn form factor, panoramic image stitching, and heat maps make photo acquisition and image transfer to the EMR seamless”, highlights Ambati.
The doctor remarks that using the equipment does not break the clinic workflow and points out the capacity to acquire images through a 2,5mm-wide pupil as “impressive”.
Furthermore, the ease of taking photos and making the documentation simplifies the doctors’ work. The exams are automatically sent to EyerCloud, a platform for remote diagnosis.
Another pro from Eyer is its portability: one can handle it manually or stabilize it on a slit lamp.
The patient becomes more engaged in the treatment, according to Ambati
As it makes device imaging available in real time, Ambati says the patients appreciate the chance to learn about their condition and what goes on with their retinas.
The ophthalmologist tells that both them and the medical team were impressed by the way the heat maps of retinal elevation reveal the pathology. “It is a factor that motivates patients to be involved with the treatment and take diabetes or DMRI seriously”, he says.
Phelcom Eyer
Phelcom Eyer is a portable fundus camera that works coupled to a smartphone and carries out high-quality retina exams, in a few minutes and without the need of pupil dilation.
The technology can identify more than 50 diseases, such as glaucoma, cataract, diabetic retinopathy, DMRI, retinoblastoma, hypertensive retinopathy and ocular toxoplasmosis. Currently, more than 10 million exams have already been carried out.
The device integrates to an online platform, Eyer Cloud, to which data is sent automatically. A specialist can analyze them remotely from anywhere in the world.
More than that, the embedded artificial intelligence provides intelligent functions to help the medical diagnosis and the capture of retinal exams. On the other hand, portability and the technology lower prices democratize the access to retina exams.
Phelcom Technologies
Eyer is developed by Phelcom Technologies, a startup that invests in innovation and technology to democratize visual health. The company is headquartered in São Carlos-SP, Brazil and has an operation in Boston, USA.
Launched in April 2019, the technology has already reached more than 1,2 million people all over Brazil and in countries such as the United States, Chile, Japan and Colombia.
The startup creates portable devices with embedded artificial intelligence, for immediate diagnoses. It aims to revert the fact that 75% of the 250 million cases of blindness or severe visual deficiency happen due to lack of prevention or wrong treatment.
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.
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