How a New Emphysema Device Won FDA Approval in Six Months

FDA has approved a new device intended to treat breathing difficulty associated with severe emphysema. The approval comes just two weeks after an FDA advisory panel shot down a competing technology targeting the same patient population. The agency approved Pulmonx Inc.'s Zephyr endobronchial valve through the breakthrough device designation, a pathway reserved for devices that provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition. Devices also must meet one of the following criteria: the device must represent a breakthrough technology; there must be no approved or cleared alternatives; the device must offer significant advantages over existing approved or cleared alternatives, or the availability of the device is in the best interest of patients. "I can really only sing the praises of FDA in this case," Beran Rose, vice president of marketing and business development at Pulmonx, told MD+DI. Not only did the agency grant the company a breakthrough device designation for the Zyphyr, but the product was approved in less than six months, Rose said. One of the advantages of qualifying for the breakthrough device designation is that FDA provides intensive interaction and guidance to the company on efficient device development, to expedite evidence generation and the agency's review of the product. FDA also did not require an advisory panel prior to making its decision. BTG wasn't so lucky. In Ju...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news

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Source: Critical Care Medicine - Category: Emergency Medicine Tags: Review Articles Source Type: research
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Source: Critical Care Medicine - Category: Emergency Medicine Tags: Online Letters to the Editor Source Type: research
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Source: Critical Care Medicine - Category: Emergency Medicine Tags: Online Letters to the Editor Source Type: research
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Source: Daily Express - Health - Category: Consumer Health News Source Type: news
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Source: Anaesthesia and intensive care medicine - Category: Anesthesiology Source Type: research
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Conclusion: Both lidocaine and bupivacaine caused postoperative cognitive impairment. Lidocaine was found to have a worse effect on cognitive function than bupivacaine, but the difference was not statistically significant. PMID: 30643450 [PubMed]
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