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.”
Prescient’s CleanCision has been shown to reduce Surgical Site Infection risk by 61 percent.
Angela Macfarlane Brings Decades of Medtech Experience and Mentoring Acumen to Fogarty Institute Board
Some people’s careers are a straight path, while others are a winding road. The latter was the case for Angela Macfarlane. After all, not many people can say they started their career in the field of law as a judicial extern for the United States District Court,
Japan Biodesign and Other Organizations from Around the Country and the World Visit the Institute to Learn about Innovation and Entrepreneurship
Nihon Kohden, the leading developer, manufacturer and distributor of medical electronic equipment, has had an illustrious history in innovation since its inception in 1951,
Zach Edmonds shares his view on the intersection between medical practice and innovation
On the surface, you may not realize how many traits clinicians and entrepreneurs share, but Zachary (Zach) Edmonds, MD, has been able to successfully pursue both fields. While he was intrigued by the human body and its ability to heal and adapt
Unconditional passion for the industry. A patient-first mindset. Grit. A selfless willingness to give back to the field to help advance the next generation of entrepreneurs and inventors.
These are just a few of the traits that describe the individuals drawn to the medical device industry, and one of the aspects that makes it so unique and strong.