MASSDEVICE ON CALL — Smartphones are capable of meeting all the criteria for an artificial pancreas by providing close-loop, outpatient control of glucose levels for diabetics, according to a new study published by the American Diabetes Assn.
The Center for Medicare & Medicaid Service’s proposal to cut about 12% from its End-Stage-Renal-Disease treatment reimbursement program drew harsh words from the non-profit Renal Support Network.
Organization CEO Lori Hartwell called the proposal "draconian" and warned that the cuts most harms patients, especially those with limited access to dialysis care.
The FDA recommended bumping blood access devices down from Class III to Class II regulatory status, based on mounting evidence that these implanted tubes, catheters and cannulae belong in a lower-risk category.
The federal watchdog agency said there’s enough safety and efficacy data to peel off a layer of regulatory oversight. Unlike the highest-risk Class III category, Class II devices are subject special controls, such as labeling rules and performance standards, but are exempt from the FDA’s stringent pre-market approval protocol and its attendant clinical trial requirements.