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the FDA’s current thinking on what qualifies as safe standards for medical device laboratory testing, according to the draft guidance published Aug. 28.

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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.
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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
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