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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ConclusionsImplementing the IMA was associated with significant reductions in VAP rates in intensive care units within Argentina.
Source: American Journal of Infection Control - Category: Infectious Diseases Source Type: research
Opioid use has reached epidemic proportions over the past decade, becoming one of America’s highest-priority public health issues. With opioid abuse spiraling out of control, lawmakers, regulators, and health professionals are scrambling to better understand key drivers of this issue and develop an effective action plan. Although the devastating impact of opioids on families and communities is well known, less focus has been given to how it affects the workplace and the role that employers and health care plan sponsors can play in combating it. Opioids’ impact on America’s workforce Opioid use is surging ...
Source: Kevin, M.D. - Medical Weblog - Category: General Medicine Authors: Tags: Policy Pain Management Public Health & Source Type: blogs
CONCLUSIONS: There is an urgent need for further research that can help guide clinical decision-making with patients who may not benefit from LCS owing to coexisting chronic illness. This statement establishes a research framework to address essential questions regarding how to incorporate and communicate risks of comorbidities into patient selection and decisions regarding LCS. PMID: 30004250 [PubMed - in process]
Source: American Journal of Respiratory and Critical Care Medicine - Category: Respiratory Medicine Authors: Tags: Am J Respir Crit Care Med Source Type: research
In conclusion, ET improves autonomic modulation in COPD with additional benefits for strength and cardiorespiratory capacity similar to conventional training. PMID: 30003108 [PubMed - in process]
Source: Biomed Res - Category: Research Authors: Tags: Biomed Res Int Source Type: research
Conclusions: Patients with gynecomastia presented more often with aesthetic concerns and secondarily with breast pain. The most frequent final diagnosis was idiopathic gynecomastia, whereas the most frequent identified etiologies were anabolic steroids consumption, hypogonadism, and use of pharmaceutical drugs. Despite the low frequency of etiologies such as thyroid dysfunction or adrenal carcinoma, we emphasize the importance of a thorough assessment of the patient, as gynecomastia may be the tip of the iceberg for the diagnosis of treatable diseases. PMID: 30003107 [PubMed - in process]
Source: Biomed Res - Category: Research Authors: Tags: Biomed Res Int Source Type: research
Conclusion: Leptospirosis is a common cause of undifferentiated tropical febrile illness in Colombia; it is important to establish ongoing and accurate surveillance for acute febrile illness to facilitate the detection of cases of leptospirosis. PMID: 30003104 [PubMed - in process]
Source: Biomed Res - Category: Research Authors: Tags: Biomed Res Int Source Type: research
ve; A Abstract The study presents a report of 58 metastatic cancer patients who developed osteonecrosis of the jaws after being treated with zoledronic acid and taxanes, plus corticosteroids. A retrospective analysis of data registered in the archives of two Italian osteonecrosis of the jaws treatment centers, who are based at the University of Messina and at the University of Palermo, was performed in order to study, in these patients, demographic data and characteristics such as frequency of cancer location, lines of therapy, frequency of cancer drugs, presence/absence of oral trigger, number, location, and stag...
Source: Biomed Res - Category: Research Authors: Tags: Biomed Res Int Source Type: research
Publication date: Available online 27 June 2018Source: Clinical Lymphoma Myeloma and LeukemiaAuthor(s): Satoshi Ichikawa, Noriko Fukuhara, Yasushi Onishi, Ryo Ichinohasama, Hideo HarigaeAbstractA 53-year-old male suffering from fever, multiple skin nodules and gastric ulcer had been diagnosed as a rare and aggressive subtype of malignant lymphoma with a γδ T-cell phenotype. Cord blood transplantation was performed after achievement of a certain disease control by some courses of chemotherapy. Unfortunately lymphoma relapsed as early as two months after transplantation; however, it has been successfully and cont...
Source: Clinical Lymphoma Myeloma and Leukemia - Category: Cancer & Oncology Source Type: research
CONCLUSIONS Our study provided evidence that ETSSA can restore the limb function recovery to a greater extent, and accelerate the regeneration of nerve fibers in rats with BPI; the effect of ETSSA was better than that of ETSA. PMID: 30001299 [PubMed - in process]
Source: Medical Science Monitor - Category: Research Tags: Med Sci Monit Source Type: research
Conclusions: According to the previous studies, COPD patients with PE experienced an increased risk of death and prolonged length of hospital stay. Therefore, the thromboembolic risk in patients with acute exacerbation of COPD, especially in the hospitalized patients, should carefully be evaluated. PMID: 29998894 [PubMed - in process]
Source: Chinese Medical Journal - Category: General Medicine Authors: Tags: Chin Med J (Engl) Source Type: research
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