As the first and only device cleared by the FDA to collect cells from the fallopian tubes, the Mako 7 device, originally developed by nVision, a Fogarty Institute graduate, offers a potential platform for earlier detection of ovarian cancer. The company was recently acquired by Boston Scientific, as the device represents an exciting opportunity for the company to expand its focus on women’s health and provides a potential platform to improve care for women worldwide.
Navigating through the Food and Drug Administration’s (FDA) policies, laws, pathways to approval and potential changes to existing regulations can be an intimidating process, especially for new or early-stage medical device startups. However, the organization has done an admirable job at proactively developing educational programs and reaching out to the industry and consumers.
As any successful medtech company knows, developing an innovative device is just the first step in improving patient care. Once that idea has come to fruition, regulatory approval begins, which is why medtech startups need an ally who can help walk them through the process and be their voice with the regulatory bodies who will ultimately grant approval and reimbursement,
“A truly prosperous American economy is one that is diversified, driven by innovation and works for all people. I believe that to achieve this across the country, we must embrace technology and use it as a vehicle to put people to work. I support advanced American manufacturing, as well as a nationwide investment in high-tech apprenticeships and worker training programs.”
At the Fogarty Institute we depend on our board of seasoned professionals to help us continue to grow and adapt to the medtech market. That’s why we were delighted to add another elite name to our esteemed group, with Stacy Enxing Seng joining as our newest member. With nearly 30 years of experience in the medtech industry,
“There is a better way” is a common mantra heard frequently in discussions between Fogarty Institute mentors and its entrepreneurs. It’s what drives us each day to devise and create new technologies that will transform patient care. And while the process is not always easy, there is nothing more rewarding than seeing a successful patient outcome as a result of a device that was created right here,