MASSDEVICE ON CALL — U.S. federal regulators cleared up some questions for medical device companies about "good laboratory practice," making it clear that the agency’s tougher standards don’t apply in very early-stage research.
The FDA clarified that, when testing a device for basic effectiveness, companies do not need to abide by the more strict quality guidelines that apply to later-stage work.
Once the new guidance is finalized, it will represent the FDA’s current thinking on what qualifies as safe standards for medical device laboratory testing, according to the draft guidance published Aug. 28.
Postponing unnecessary biopsies with ultrasound
Ultrasound imaging might be a promising way to postpone thyroid biopsies for patients with a low risk of developing cancer, a study says. Researchers at the University of California, San Francisco, retrospectively analyzed 8,806 patients who received ultrasound exams and identified 3 thyroid nodule characteristics that had an associated cancer risk. Study authors concluded that it is important for doctors to be critical of which thyroid nodules really represent cancer risks and warrant a biopsy.
Hospitals up-charge saline solution 1,000%, reporting finds
Hospitals pay between $1 and $5 per bag of saline solution, and charge patients between $100 and $500, according to reports from The New York Times. These saline solution bags are used frequently in hospitals for IV drips, and numerous reports reveal that hospitals routinely up-charge for this service, leaving the patient with a a bill that is more than 100 times the costs of the bag.
Defying expectations, elderly are most likely avoid Obamacare mandates
Older Americans are more likely to dodge healthcare insurance mandates, according to a new survey of uninsured by Deft Research. Uninsured elderly patients are most concerned about
the cost of coverage through the insurance marketplaces, set to open October 1. The survey showed that this population is more likely to defy the mandate than younger populations.
Kim Bariatric Institute marks 10 year anniversary
The weight loss institute Kim Bariatric celebrated its 10-year-anniversary this week with an effort to encourage patients to share their own weight-loss stories. Dr. David Kim, who
founded the institute in 2003, was the 1st surgeon to perform bariatric bypass surgery. The Kim Bariatric institute helps obese patients develop treatment plans. As part of the 10-year-anniversary celebration, the Texas-based treatment center is asking patients to submit their experiences with bariatric surgery online.