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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HIGH BLOOD pressure doesn ’t usually have symptoms, however sometimes there are certain signs which could indicate the condition. One such symptom is pain in a particular part of the body.
Source: Daily Express - Health - Category: Consumer Health News Source Type: news
You're reading 5 Approaches to Combat Stress Through a Healthier Mind-Body Connection, originally posted on Pick the Brain | Motivation and Self Improvement. If you're enjoying this, please visit our site for more inspirational articles. To accomplish the highest level of health, it is important to know and accept that the mind and body are tightly intertwined. This concept itself is far from new, but knowing how to leverage the connection is becoming increasingly intriguing. More than a century ago, Harvard psychologist Walter Bradford Cannon drew people's attention to the mind-body connection when he described...
Source: PickTheBrain | Motivation and Self Improvement - Category: Consumer Health News Authors: Tags: featured happiness meditation self improvement mindfulness unfocus Source Type: blogs
(Natural News) Organ transplants are considered one of the greatest advances of modern medicine. It’s incredible to think that an organ that is no longer needed by one person can be placed into someone else’s body and give them a new lease on life. Of course, it’s also one of the riskiest medical procedures –...
Source: NaturalNews.com - Category: Consumer Health News Source Type: news
This study aimed to identify the risk factors associated with complications and/or graft failure in kidney transplant patients with sepsis. A total of 14,658 kidney transplant patients with sepsis, identified in the National Inpatient Sample (NIS) database (data from 2005-2014), were included in the study and classified into three groups: patients without complications or graft failure/dialysis (Group 1), patients with complications only (Group 2), and patients with complications and graft failure/dialysis (Group 3). Multinomial logistic regression analyses were conducted to evaluate factors associated with kidney transpla...
Source: Bosnian Journal of Basic Medical Sciences - Category: General Medicine Tags: Bosn J Basic Med Sci Source Type: research
CONCLUSION: The specific central and peripheral metabolites were associated with psychological disorders including depression, anxiety, suicidal ideation and anger in CRPS patients, showing pathological interactions between a painful body and mind. PMID: 30235917 [PubMed]
Source: Psychiatry Investigation - Category: Psychiatry Tags: Psychiatry Investig Source Type: research
Uptake and metabolism of mizoribine, an immunosuppressant, in L5178Y-R mouse lymphoma cells in vitro and peripheral blood mononuclear cells of rats and kidney transplant recipients in vivo. Drug Metab Pharmacokinet. 2018 Aug 25;: Authors: Oda K, Mori N, Okumi M, Furusawa M, Ishiguro M, Inoue K, Shuto S, Unagami K, Ishida H, Tanabe K, Murakami T Abstract The cellular uptake of mizoribine (MZR), an immunosuppressant, and metabolism of MZR to MZR-5'- monophosphate (MZRP), an active metabolite, were evaluated in L5178Y-R mouse lymphoma cells and peripheral blood mononuclear cells (PBMCs) of rats ...
Source: Drug Metabolism and Pharmacokinetics - Category: Drugs & Pharmacology Tags: Drug Metab Pharmacokinet Source Type: research
Authors: Schreiber A, Cemmi F, Ambrosino N, Ceriana P, Lastoria C, Carlucci A Abstract The aim of our study was to evaluate the prevalence and predictors of obstructive sleep apnea (OSA) in patients with chronic obstructive pulmonary disease (COPD) undergoing inpatient pulmonary rehabilitation programs (PRPs). A retrospective data review of consecutive stable patients with a known diagnosis of COPD, admitted for PRP between January 2007 and December 2013. Full overnight polysomnography (PSG) and Epworth Sleepiness Scale (ESS) were assessed in all patients. Out of 422 evaluated patients, 190 (45%) showed an Apnea Hy...
Source: COPD: Journal of Chronic Obstructive Pulmonary Disease - Category: Respiratory Medicine Tags: COPD Source Type: research
Authors: Brignardello-Petersen R PMID: 30241920 [PubMed - as supplied by publisher]
Source: Journal of the American Dental Association - Category: Dentistry Tags: J Am Dent Assoc Source Type: research
CONCLUSION: DMEK-S - hybrid endothelial transplantation in complicated eyes in the evaluated group of patients led to a noticeable improvement of visual acuity. When compared to surgeries in uncomplicated eyes, DMEK-S results in a higher rate of postoperative complications, especially graft detachment and primary failure. PMID: 30238934 [PubMed - as supplied by publisher]
Source: Biomedical Papers of the Medical Faculty of the Univ Palacky Olomouc Czech Repub - Category: Biomedical Science Tags: Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub Source Type: research
Authors: Gupta N, Wikenheiser-Brokamp K, Zander D, Balestra R, Selvaraju A, Niehaus K, Benzaquen S Abstract A 47-year old female was evaluated in our clinic for an incidental discovery of diffuse cystic lung disease on high-resolution computed tomography (CT) scan of the chest. There was no personal or family history of tuberous sclerosis complex (TSC), sicca symptoms, pneumothorax, or skin or renal tumors. Review of her chest CT scan showed bilateral, round, uniform, thin-walled cysts present in a diffuse distribution characteristic of lymphangioleiomyomatosis (LAM). CT scan of the abdomen and pelvis did not revea...
Source: Lymphology - Category: Internal Medicine Tags: Lymphology Source Type: research
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