MASSDEVICE ON CALL — Teenaged delegates from the Juvenile Diabetes Research Foundation testified on Capitol Hill, urging Congress to accelerate research and review of artificial pancreas systems for managing insulin for patients with type 1 diabetes.
"After participating in clinical research since I was three years old, I can honestly say the closed loop artificial pancreas trial was the most amazing experience of my entire life and holds so much promise for people living with this disease," said Kerry Morgan, a 17-year-old JDRF Children’s Congress delegate from Glen Allen, Va., who testified before the Senate Committee on Homeland Security and Government Affairs this week.
The news comes on the heels of an FDA draft guidance regarding low glucose suspend artificial pancreas systems that help reduce the severity of a drop in glucose levels by automatically adjusting insulin flow.
The giudance document addressed premarket approval and investigational device exemption for the devices, which combine a continuous glucose monitor, an insulin infusion pump and a glucose meter in a closed-loop system.
"JDRF’s goal is to find a cure for type 1 diabetes. But there are transformational treatments, such as an artificial pancreas, which could help individuals live better with type 1 diabetes today and keep them healthy until that cure is found," JDRF officials said in a statement.
Johnson & Johnson retools internationally
The New Brunswick, N.J.-based medical products giant plans to build an innovation center in Suzhou City, about 90 minutes outside of Shanghai, to serve as a research hub.
"We want to take an approach that involves getting insights into the local medical need and using those insights to tailor our devices," Alex Gorsky, who runs JNJ’s medical device business, told the online news source. "In some cases, you need a very different product."
One product they won’t be revamping – their stents, which they’re dropping by the end of the year.
University of Minnesota launches device for pulmonary hypertension
The University of Minnesota licensed technology to Aria CV, Inc., for development and commercialization of a medical device to treat pulmonary hypertension.
Pulmonary hypertension is abnormally high blood pressure in the arteries of the lungs, which can lead to heart failure.
The invention was initially funded by the University’s Medical Devices Center Innovation Fellows Program, and several of the center’s former fellows will head the privately held startup to develop the device, according to the release.
HHS issues another $500 million for patient safety
The Obama administration made $500 million available for hospitals, insurers and employers to reduce medical errors and hospital readmissions, Healthwatch reported.
The funds are the second half of a $1 billion investment promised in April.
The funds provide for "Hospital Engagement Contractors" who will design programs to teach hospital staff about making care safer, provide technical assistance and create tracking systems to monitor hospital progress.
Employee health insurance availability is down; new health care laws will help
Fewer employers offer health care now than they did ten years ago, according to a report by the Robert Wood Johnson Foundation.
The decline is especially severe for small businesses and families making between $44,000 and $88,000, Healthwatch reported.
The share of employers that offer coverage fell by 3.6 percent from 1999 to 2009, but the foundation expects that share to rebound 10 percent in response to President Barack Obama’s health care reform efforts.