The Medical Device Business Journal — Medical Device News & Articles | MassDevice
Dr. Margaret Hamburg, who resigned as FDA commissioner in February, was named foreign secretary of the U.S. Institute of Medicine this week.
Hamburg spent 6 years leading the federal safety watchdog, overseeing a massive revamp of its medical device, drug, food and tobacco regulation.
MASSDEVICE ON CALL — A newly identified molecular signature might help doctors predict likelihood of death in sepsis patients. Sepsis, a disease caused by uncontrolled infection, usually triggers the body to "switch on" a metabolism-boosting process, which enhances survival chances.
MASSDEVICE ON CALL — Nearly ⅓ of every dollar spent on healthcare in the U.S. is wasted, amounting to about $750 billion down the drain each year, according to a new Institute of Medicine report.
The wasted costs are mostly associated with excessive paperwork, unnecessary procedures, healthcare fraud and other items that are draining the nation’s health systems, the IOM found.
MASSDEVICE ON CALL — University of California researchers recommended that women be more wary of breast cancer imaging exams, warning that excess testing may increase a women’s risk of developing breast cancer.
Reserachers dug deeper into an Institute of Medicine report on the environmental factors contributing to breast cancer, focusing on radiation exposure tied to breast cancer diagnostic imaging exams.
MASSDEVICE ON CALL — A German team developed a new hip replacement implant that may be the answer to the high-profile hip device debates following the recall of DePuy’s metal-on-metal implants.
The researchers announced new hip implants that "unlike the conventional counterpart implants on the market today, provide a metal-free solution and bone-like elasticity."
MASSDEVICE ON CALL — The FDA licensed a stem cell transplant product derived from umbilical cord blood for the first time in approval for the New York Blood Center’s Hemacord.
Hemacord can be transplanted into patients with disorders affecting blood cells. The product’s license includes use with children.
Umbilical cord blood is one of few sources of hematopoietic progenitor cells, stem cells that can turn into any type of blood cell. The stem cells are transplanted into patients, where they mature in the bone marrow.
High costs, long review times and increasing unpredictability led more than three-quarters of medical device makers to seek overseas regulatory approval before launching a bid for FDA clearance, according to the largest-ever survey on the 510(k) review process.
Of 350 medical device company employees reviewed, 22 percent said high costs of FDA review sent them overseas and 14 percent blamed a lengthy and complicated U.S. review process, according to a report by researchers at Northwestern University.
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