Business Wire05.22.20
MedX Health Corp. has received regulatory approval to market and sell its SIAscopy on DermSecure skin assessment platform in Brazil. “MedX has worked seamlessly with its Brazilian distribution partners, MedX Brasil and Oneway Diagnostica to ensure we were able to complete this important certification from ANVISA, Brazil’s regulatory authority,” said Scott Spearn, president and CEO of MedX. “We had the support of the Brazilian Dermatological community in this process, and we are very appreciative of the efforts and professionalism of our partners in achieving this milestone.”
"There is a significant opportunity for MedX’s rapid skin assessment technology in Brazil, as skin cancer is the most common type of cancer in Brazil,” stated Fabio Candello, CEO of MedX Brasil. More than 100,000 new cases of skin cancer were recorded in Brazil between 2016 and 2017, according to the Brazilian Cancer Institute, and almost 6,000 were classified as melanoma, an aggressive form of the disease that can spread to other parts of the body. A recent study shows that Brazilian melanoma patients experienced a lower survival rate than the current worldwide average. The high prevalence of advanced cases reinforces the importance of local strategies to diagnose melanoma in the early stages, and to treat it definitively.
“MedX’s SIAscopy on DermSecure telemedicine platform and advanced SIAscopy imaging technology is a perfect solution for early detection,” noted Candello.
“MedX Brasil has ordered 500 SIAscopes to meet their initial demand, and now that we have received regulatory approval and our distribution partners can begin active marketing, we are ramping up along with our partners to fulfill this order, and will begin to see the impact of the recurring revenue model going forward,” said Spearn.
Last month, MedX Health Corp. achieved a recommendation for continued certification on successful completion of an audit under the Medical Device Single Audit Program (MDSAP). MDSAP is a stringent audit process undertaken on medical device manufacturers’ quality management systems that is recognized by regulatory bodies for compliance of the regulatory requirements under ISO-13485:2016 and in addition, those in Canada, the United States, and Australia.
"Achieving the MDSAP certification confirms our ongoing commitment to maintaining the highest quality assurance standards within the Medical Device Industry and provides compliance in all of the jurisdictions we are operating in, including Brazil. The entire MedX team is to be commended for the effort put in through this process,” said Spearn.
"There is a significant opportunity for MedX’s rapid skin assessment technology in Brazil, as skin cancer is the most common type of cancer in Brazil,” stated Fabio Candello, CEO of MedX Brasil. More than 100,000 new cases of skin cancer were recorded in Brazil between 2016 and 2017, according to the Brazilian Cancer Institute, and almost 6,000 were classified as melanoma, an aggressive form of the disease that can spread to other parts of the body. A recent study shows that Brazilian melanoma patients experienced a lower survival rate than the current worldwide average. The high prevalence of advanced cases reinforces the importance of local strategies to diagnose melanoma in the early stages, and to treat it definitively.
“MedX’s SIAscopy on DermSecure telemedicine platform and advanced SIAscopy imaging technology is a perfect solution for early detection,” noted Candello.
“MedX Brasil has ordered 500 SIAscopes to meet their initial demand, and now that we have received regulatory approval and our distribution partners can begin active marketing, we are ramping up along with our partners to fulfill this order, and will begin to see the impact of the recurring revenue model going forward,” said Spearn.
Last month, MedX Health Corp. achieved a recommendation for continued certification on successful completion of an audit under the Medical Device Single Audit Program (MDSAP). MDSAP is a stringent audit process undertaken on medical device manufacturers’ quality management systems that is recognized by regulatory bodies for compliance of the regulatory requirements under ISO-13485:2016 and in addition, those in Canada, the United States, and Australia.
"Achieving the MDSAP certification confirms our ongoing commitment to maintaining the highest quality assurance standards within the Medical Device Industry and provides compliance in all of the jurisdictions we are operating in, including Brazil. The entire MedX team is to be commended for the effort put in through this process,” said Spearn.