FDAnews Device Daily Bulletin
Oct. 4, 2012 | Vol. 9 No. 195
FDA enforcement of unique device identifier (UDI) requirements will likely be delayed to allow for ample implementation time, but unwritten mandates in the draft rule with the potential to snarl inspections require prompt attention, compliance experts and former agency officials say.
Telemetry company ScottCare has corrected all violations found during a site inspection earlier this year, earning an Aug. 13 closeout letter from the FDA’s Cincinnati District Office.
Argo Medical Technologies, an Israeli company that makes devices enabling paraplegics to walk, said it will open its U.S. headquarters in Massachusetts and expects to hire up to 40 people here within the next three to five years.
Alberto Osio said he has a way to help older people see better.
In the operating room, surgeons can see inside the human body using advanced imaging techniques, but primary care physicians, the people who are on the front lines of diagnosing illnesses, haven’t commonly had access to the same technology — until now.
Hopkins Medical products announced the release of its Newborn & Mom pulse oximeter kit.
St. Jude Medical’s Peripheral Nerve Stimulation Study Confirms Benefit for Chronic Migraine Patients
St. Jude Medical announced publication of results from the first large-scale study of peripheral nerve stimulation of the occipital nerves in patients suffering from chronic migraine.
Clemson University has established the first program to train engineers to recycle and reprocess medical devices.
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