Greenlight Guru and bioaccess™ share the same goal and mission: To enhance the quality of life by helping Medtech manufacturers get to market faster, with less risk. Greenlight Guru and bioaccess™ announce their cooperation agreement to bring medical device companies closer to Latin America and conduct early-stage clinical trials or sell their innovations.
Read MoreSpine Stabilization Technologies, LLC (SST), a Texas company developing a spine disc nucleus replacement technology designed to replace the physical space of the nucleus, has decided to engage bioaccess™ as its CRO in Colombia to expand its clinical research network of sites and augment the clinical data of its innovative and less invasive treatment: The PerQdisc™ Nucleus Replacement System.. bioaccess™ will help SST select at least two clinical research sites and obtain institutional review board (IRB)/ethics committee and regulatory approval at Colombia's regulatory agency (INVIMA).
Read MoreWelwaze Medical Inc., the manufacturer of the innovative Celbrea® medical device for the detection of early signs of breast disease, has decided to enter the Latin American market and through its master distributor in Latin America, has chosen bioaccess™ as its regulatory and market access consulting firm to aid it in entering the Colombian market.
Read MoreAdaptive Testing Technologies (ATT), a Chicago-based company; and bioccess™, an Orlando-based market access consulting firm dedicated to helping innovative Medtech companies succeed with their market expansion plans in Latin America, announced that they have entered into a partnership agreement to market and commercialize the CAT-MH™ –the only multi-dimensional clinically validated adaptive behavioral health measures in the world –in Latin America.
Read MoreNeuraMetrix, a San Francisco-based company with breakthrough medical technology to detect and monitor mental disorders and brain diseases through typing cadence; and bioaccess™, an Orlando-based contract research organization (CRO) and market access consulting firm dedicated to helping innovative Medtech companies succeed with their market expansion plans in Latin America, announced that they have entered into a partnership agreement to conduct clinical research and commercialize the brain health monitoring tool based on typing cadence in Latin America.
Read MoreHasten LLC, a company specialized in enabling and accelerating the entry of new innovative products, devices, solutions, and technologies in developing countries, has chosen bioaccess™ to obtain regulatory registration and market clearance for its clients, Palette Life Sciences, Germitec, and Bioderm at INVIMA in Colombia, and help guide Hasten's market access strategy in the country.
Read MoreEmergo by UL ("Emergo"), a global medical device and healthcare technology consultancy, and bioaccess™, a medical device contract research organization and market access consultancy focused in Latin America, have announced an agreement to help each other's clients with their clinical research, regulatory compliance and market access needs in Brazil, Colombia, Costa Rica, Mexico, and Peru — some of the most attractive medical device markets in Latin America.
Read MoreChina-based Resvent has chosen bioaccess™ as its regulatory and market access partner to obtain marketing authorization at Colombia's INVIMA towards the commercialization of its sleep apnea iBreeze series of medical devices. bioaccess™ will also search and select a leading distributor for Resvent in Colombia.
Read MoreIsrael-based Sight Diagnostics has chosen bioaccess™ as its regulatory and market access partner to obtain marketing authorization towards the commercialization of its innovative point-of-care blood diagnostic device, OLO. The OLO device uses artificial intelligence (AI) to optically read small amounts of blood and provide complete blood count tests during a single doctor’s visit. In 2018, Sight Diagnostics received its CE mark and begun selling its OLO device in Europe and other countries.
Read MoreMANDALA International ("MANDALA"), a leading regulatory consulting company in France, and bioaccess.™ announce a cooperation agreement to work together to help each other's clients with their regulatory and market access needs in Brazil, Colombia, and Mexico —the top three medical device markets in Latin America. Under this cooperation agreement between MANDALA and bioaccess.™, now foreign manufacturers of medical technologies will be able to cost-effectively and timely obtain market clearance for their products, have a well thought out market access plan, and find reliable local distributors so that they can achieve meaningful sales and have long-term growth in Brazil, Colombia, and Mexico —the top three medical device markets in Latin America.
Read MoreIDx Technologies Inc. has chosen bioaccess.™ as its market access consultant to search, find, and select high-volume ophthalmology centers in Latin America that can be its data-licensing collaboration partners for its breakthrough autonomous artificial intelligence (AI) system that detects diseases in medical images. By enabling diagnostic assessment in primary care settings, IDx aims to increase patient access to high-quality, affordable disease detection.
Read MoreBiomerica, Inc. (Nasdaq: BMRA) has chosen bioaccess.™ as its regulatory and market access partner to obtain marketing authorization and commercialize its innovative EZ Detect colorectal screening test in Colombia. The EZ Detect colorectal screening test is the simplest and most affordable way to help identify the early warning signs of colorectal cancer (CRC). Globally, colorectal cancer is the third most common type of cancer, making up about 10% of all cases.
Read MoreIOPtima Ltd.—an innovative ophthalmology medical device company based in Israel— has selected bioaccess.™ as its market access and business development consultant to expand its market reach to Latin America. bioaccess.™ will assist IOPtima with searching and selecting distributors in Colombia, Chile, Mexico, and Peru.
Read MoreWEP Clinical —a London-based drug sourcing, and distribution company— has selected bioaccess.™ as its market access, regulatory and business development consultant to enter the Colombian market for hard-to-find drugs. For hospitals or health management organizations (HMOs) that want to provide a life-saving and hard-to-find drug to their patients, WEP Clinical offers an efficient, end-to-end product distribution model. From the required regulatory filings, through to product handling and delivery, WEP Clinical is well positioned to support patient's needs.
Read MoreMillenlum Medical Technologies, Inc. ("MMT"), a company specializing in manufacturing and distributing medical devices in liposuction, body shaping, adipose tissue collection and transfer, and autologous cell processing, has selected bioaccess.™ as its market access, regulatory consultant and legal representative in Colombia. bioaccess.™ will help MMT conduct market research, build a distribution network, and obtain marketing authorization for its novel AcquiCell® equipment at Colombia's medical device regulatory agency, INVIMA.
Read MoreBIORIUS SPRL ("BIORIUS"), a leading regulatory consulting company in Belgium, and bioaccess.™ , the leading CRO and regulatory consulting company in Colombia, announce a cooperation agreement for Colombia. BIORIUS and bioaccess.™ will work together to help each other clients with their regulatory needs in Colombia and Europe.
Read MoreOmron Healthcare, Inc. ("Omron") has appointed bioaccess.™ as its market access consultants in Colombia. bioaccess.™ will help Omron formulate a strategy and implementation plan in Colombia so that more hypertensive patients have access to Omron's automated home blood pressure (BPM) monitors in Colombia.
Read MorePOM Medical, LLC ("POM") has appointed bioaccess.™ as its market access, regulatory consultant and legal representative in Colombia. bioaccess.™ will help POM conduct market research, build a distribution network, and obtain marketing authorization for its novel Panoramic Oxygen Mask at Colombia's medical device regulatory agency, INVIMA.
Read MoreClarVista Medical, Inc. ("ClarVista"), a privately-held ophthalmic device company —acquired by Alcon in 2017— developer of the HARMONI Modular IOL System, a novel intraocular lens (IOL) used to restore vision after cataract surgery, obtained regulatory approval at Colombia's INVIMA to commercialize its HARMONI Modular IOL. bioaccess.™ led the registration process and became ClarVista's legal representative in Colombia.
Read MoreMedimaps Group has appointed bioaccess.™ as its regulatory consultant and legal representative in Colombia. bioaccess.™ will help Medimaps Group register its novel method for improving osteoporotic fracture risk assessment, TBS iNsight®, at Colombia's medical device regulatory agency, INVIMA. Medimaps Group – developers of the TBS iNsight® diagnostic tool – and bioaccess.™ signed a service agreement to have Medimaps Group's TBS iNsight® product registered for sales in the Colombian territory.
Read More
