eNews February 26, 2020

The latest news affecting you and your customers… from the Independent Medical Specialty Dealers Association

Meet tomorrow’s doctors. (They’re pretty smart!)

IMDA members: Imagine representing technology from a company founded by a medical doctor with a master’s degree in engineering. Texas A&M System is beefing up its two-degree program known as EnMed with new facilities and lab space. (Completion is expected in June 2023.) EnMed students will complete the requirements for master’s degrees in engineering and doctorates of medicine, while also being required to invent new devices or processes before they graduate.

FDA keeps an eye on Chinese medical imports

Although the FDA can’t inspect drug and medical device manufacturing operations in China (due to the novel coronavirus outbreak), the agency is assuring consumers and healthcare providers that it continues to monitor the safety of products coming from that country. “We already use other tools to help complement our inspections, including import screening, examinations, sampling, and import alerts, relying on a firm’s previous compliance history, and we use information from foreign governments as part of mutual recognition agreements,” the FDA said in a statement on Feb. 24. “Thus, at this time, we can rely on these other tools to give us comprehensive oversight of FDA-regulated products entering this country.

Generic inhalation aerosol approved

The FDA has approved the first generic of ProAir HFA (albuterol sulfate) Inhalation Aerosol for the treatment or prevention of bronchospasm in patients four years of age and older with reversible obstructive airway disease and the prevention of exercise-induced bronchospasm in patients four years of age and older. “Today’s approval of the first generic drug product for one of the most commonly used rescue inhalers in the U.S. is part of our longstanding commitment to … expand opportunities to bring generic copies of complex drugs to the market,” FDA Commissioner Stephen M. Hahn, M.D., said in a statement.

Heart valve expands as the child grows

A new type of heart valve could remove the need for children with congenital heart disease to undergo multiple open-heart surgeries by growing alongside them, reports Verdict Medical Devices. Researchers at Boston Children’s Hospital used benchtop studies, computer simulations and extensive testing in large animal models to develop the valve. They found that the new prosthetic design works across a wide range of sizes and retains its functionality when expanded via a minimally invasive balloon catheter procedure. The results of the project have been published in Science Translational Medicine. Current prosthetic heart valves are fixed in diameter, so need to be replaced every few years as a child grows. If a child has their first surgery before the age of two, they may need as many as five open-heart surgeries before adulthood.