The company solidified its presence in the country by participating in significant events such as Vision Expo East, held from March 16 to 19 in New York, ARVO, from April 23 to 27 in New Orleans, and ASCRS, from May 5 to 8 in San Diego.
“These events bring forth many innovations, products, services, research, and advancements that not only keep us updated but also allow us to introduce Eyer to doctors, healthcare professionals, scientists, researchers, pharmaceutical companies, distributors, and potential partners in a relevant and swift manner,” emphasizes Phelcom’s International Manager, Mário Costa.
Phelcom showcased the portable retinal camera Eyer at the ARVO congress in 2023.
FDA Approves Eyer as 510(k)/FDA Cleared
Recently, the FDA (Food and Drug Administration) granted approval for Phelcom’s portable retinal camera, Eyer, as 510(k). Previously considered an exempt device, the technology was limited to patient photo documentation.
“Now, as we are FDA Cleared, Eyer can be used for diagnostic and telemedicine purposes. This new classification, the highest in our category, opens up more opportunities for our American clients to use our equipment both inside and outside the office,” Costa highlights.
Upcoming International Events
Phelcom will take part in several international trade shows and congresses in the second half of the year. Check out the schedule:
Phelcom Eyer is a portable retinal camera that attaches to a smartphone and conducts high-quality retinal exams within minutes without the need for pupil dilation.
This technology aids in diagnosing over 50 diseases, including glaucoma, cataracts, diabetic retinopathy, AMD, retinoblastoma, hypertensive retinopathy, and ocular toxoplasmosis. It is available in Brazil, the United States, Japan, Chile, Colombia, and will soon become available in other countries.
Portability, connectivity, and integration with intelligent functions like EyerMaps, combined with the technology’s accessible price point, contribute to increased access to retinal exams.
About Phelcom
Phelcom Technologies is a Brazilian medtech company headquartered in São Carlos, São Paulo. The company’s story began in 2016 when three young researchers – a physicist, an electronic engineer, and a computer engineer (PHysics, ELectronics, COMputing) – created a portable retinal camera integrated with a smartphone.
The idea for the first prototype arose from the interest of partner Diego Lencione in visual health, driven by his brother’s condition, which severely affected his retina and vision since childhood.
In 2019, Phelcom introduced its first product to the Brazilian market: the portable retinal camera Eyer. More than 2 million people in Brazil and around the world have been examined using Eyer so far.
In four years, the company has participated in more than 100 social initiatives and was recently named among the 10 most innovative companies in Brazil by Forbes.
Recently, Phelcom visited the MENA region to train Allm MEA on using and presenting the Eyer retinal camera. This non-mydriatic device attaches to a smartphone and performs high-quality retinal examinations in just a few minutes.
The training took place at the Allm MEA office in Dubai, United Arab Emirates. “We conducted onboarding with our distributors, who are already highly qualified to demonstrate the advantages of Eyer to customers in the region,” emphasizes Phelcom’s International Business Manager, Mário Costa.
In addition, the Phelcom team visited significant hospitals in the United Arab Emirates, such as the Al Maerid Health Center MOH in Ras Al Khaimah and the Al Qassimi Hospital in Sharjah. At the latter, Eyer was introduced to the entire ophthalmology team.
Phelcom provided training on the use and commercial presentation of the portable retinal camera, Eyer, to their local partner and distributor, Allm MEA.
Pilot Project in Egypt
Phelcom has also conducted training on the use of Eyer at Ain Shams University Virtual Hospital (AVH) in Cairo, Egypt. “We are participating in a pilot project focused on teleophthalmology at AVH, which is responsible for one of the largest telemedicine programs in the country,” Costa explains.
The hospital develops technology-enabled healthcare systems in Egypt, the Middle East, and Africa. The project involves international collaborators and beneficiaries specializing in telemedicine, e-health research, artificial intelligence, virtual reality, and innovative healthcare models.
Phelcom’s team during training on the use of Eyer at Ain Shams University Virtual Hospital.
Eyer is currently present in 6 countries.
Eyer was approved in the United Arab Emirates in the second quarter of this year. As a result, Phelcom now operates in six countries: Brazil, the United States, Japan, Chile, Colombia, and the United Arab Emirates.
Furthermore, the company is in the regulatory process for marketing Eyer in other locations such as Mexico, Egypt, and Saudi Arabia.
For Phelcom CEO, José Augusto Stuchi, being a Brazilian company operating in important global markets is a source of pride and great responsibility. “Internationalization undoubtedly expands our potential reach. However, it also increases our commitment to providing excellent quality products that truly benefit professionals,” he affirms.
Eyer
Retina examination conducted with Eyer.
Eyer is a portable retinal camera that attaches to a smartphone and performs high-quality retinal examinations in minutes, without the need for pupil dilation.
The technology aids in the diagnosis of over 50 diseases, including glaucoma, cataracts, diabetic retinopathy, AMD, retinoblastoma, hypertensive retinopathy, and ocular toxoplasmosis. To date, more than 10 million examinations have been conducted in Brazil, the United States, Chile, and Colombia.
The portability and affordable price of the technology democratizes access to retinal examinations, costing approximately ten times less than a conventional tabletop retinal camera that still requires integration with a computer.
About Phelcom
Phelcom Technologies is a Brazilian medtech company based in São Carlos, São Paulo. The company’s story began in 2016 when three young researchers – a physicist, an electronic engineer, and a computer engineer (PHysics, ELectronics, COMputing) – created a portable retinal camera integrated with a smartphone.
The idea for the first prototype emerged from the interest of co-founder Diego Lencione in visual health, as his brother has a condition that severely affects the retina and vision that he’s had since childhood.
In 2019, Phelcom launched its first product, the portable retinal camera Eyer, to the Brazilian market. Today, the technology has reached over two million people throughout Brazil and other countries it is present in..
In four years, the company has participated in over 100 social initiatives and was recently named one of the top 10 most innovative companies in Brazil by Forbes.
Brazilian General Data Protection Law (LGPD), in effect since May, 2021, regulates how to process personal data of citizens in Brazil. On the whole, it aims to keep data safety and eliminate sharing unauthorized by owner.
As telemedicine spreads in the country, medical offices, clinics and other healthcare institutions are legally obliged to follow LGPD rules. Otherwise, infringement fines may reach high values.
Therefore, it is imperative for data exchange, online consultations and exam delivery for reporting, among other medical practices, to occur in reliable and safe environments. Furthermore, the law considers data on patient healthcare as sensitive.
“The great change with LGDP relates to the concept of property of medical data. These data no longer belong to healthcare institutions. Now they exclusively belong to the patient. However, institutions are responsible for data security”. – explains Phelcom’s Data Engineering manager, Fernando Yamanaka.
For this reason, data security is a priority in Phelcom. All images made with Eyer handheld fundus camera and stored in EyerCloud, online platform to manage exams, are protected by Amazon Web Services (AWS). This computing services has the most credible database and cloud systems in the market.
“We store retina images from millions of patients. This part of the eye is known as an ‘eye fingerprint’, since it is unique for each person. That’s why we use the best information security practices to protect data from patients of our customers”, he says.
HIPAA
More than LGPD, Phelcom follows the rules of Health Insurance Portability and Accountability Act (HIPAA), a law on portability and accountability of health insurance in the United States.
Eyer is also sold in the USA. Recently, the FDA (Food and Drug Administration) approved the handheld fundus camera in the category 510(k), the highest for retinographs. Part of the regulatory process involved cyber security analyses of Phelcom’s device.
HIPAA Compliance establishes rules to protect electronic records and medical data of patients. With regards to the LGPD, it has similar goals: protect patient privacy, oblige entities to make medical records available when prompted and assure that patients are notified in case of leakage of sensitive data.
EyerCloud
Eyercloud is an online platform integrated to Eyer that allows storing and managing patients’ exams. All data the equipment captures can automatically synch to the system, so that they are uploaded with full security.
More than assuring data backup in a secure server, the user has all data organized in a friendly, functional and intuitive interface.
For instance, the tool enables evaluation of images by EyerMaps, an innovative system of Artificial Intelligence (AI) that detects any suspicious retinal abnormalities with high accuracy.
In a few seconds after capturing the fundus photo, if a suspicious alteration is detected, the AI generates a new image with a heat map, highlighting the potential abnormalities in the retina. Synchronized with EyerCloud, it classifies the captured images and exams in a simple and visual way, according to the probability of alteration, using colored markers:
Green: image or exam with low probability of alteration (up to 30%);
Yellow: image or exam with medium probability of alteration (31 to 70%);
Red: image or exam with high probability of alteration (71 to 100%).
Eyercloud helps doctors to make reports quickly, prioritize urgent cases and share all data, either printed or by e-mail, with the patients, by generating a protocol number and password.
“We invested in a complex infrastructure to secure the sensitive data of our patients. This is one of the main advantages of EyerCloud. At present, our platform stores about two million exams”, highlights Yamanaka
The manager explains that keeping sensitive data of patients in computers or storages of easy access and in unprotected systems may be risky. “Cloud systems with high security, as EyerCloud, are an essential investment to protect doctors, medical offices, clinics and hospitals from leakage of sensitive data and, consequently, from probable penalties from LGPD”.
Eyer Handheld Fundus Camera
Eyer is a portable fundus camera that works coupled to a smartphone and makes high-quality retinal exams in a few minutes, without need of pupil dilation.
The technology helps to diagnose more than 50 diseases, such as glaucoma, cataract, diabetic retinopathy, DMRI, retinoblastoma, hypertensive retinopathy and ocular toxoplasmosis. It is available in Brazil, United States, Japan, Chile, Colombia and, soon, in other countries.
Portability, connectivity and integration to intelligent functions as EyerMaps, as well as the lower cost of the technology, contribute to increase access to retina exams.
About Phelcom
Phelcom Technologies is a Brazilian medtech headquartered in São Carlos, upstate São Paulo. The company 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 integrated to a smartphone.
The project of the first prototype was born from the interest of the partner Diego Lencione on visual health. His brother has a condition that severely compromised the retina and vision since childhood.
In 2019, Phelcom lauched its first product in Brazilian market: Eyer handheld fundus camera. Nowadays, the technology has already reached more than two million people all over Brazil and the countries it is present.
In four years, the company already took part of more than 100 social actions and, recently, has been ellected one of the 10 most innovative companies in Brazil by Forbes.
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.
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