+5 | The top 5 medtech stories for September 6, 2017

Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. Did Congress just kill medical device innovation? The Medical Device User Fee Amendments bill that Congress passed this year is more than an FDA fees hike for device companies; it could inhibit innovation, says Michael Drues, a regulatory consultant based outside Boston. That’s because MDUFA 2017 includes new user fees – about $23,000 for small companies and $93,000 for large companies – for requests for de novo device classifications. Drues, who has worked with both device companies and FDA, has clients speeding up de novo applications to get them turned in before the fees take effect on Oct. 1. Read more 4. Pulmatrix licenses inhaled COPD drug to Vectura Pulmatrix said today that it licensed its inhaled COPD drug to Vectura. The PUR0200 compound combines tiotropium bromide and Pulmatrix’s iSperse drug-delivery technology. Vectura plans to use its dry powder inhaler device to deliver PUR0200, the company said. Read more 3. Boston Scientific wins FCA whistleblower suit over Cognis CRT-Ds, Teligen ICDs Boston Scientific has prevailed in dismi...
Source: Mass Device - Category: Medical Devices Authors: Tags: News Well Plus 5 Source Type: news

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Conditions:   COPD;   COPD Exacerbation Intervention:   Behavioral: patient education, training booklet, 3 months tele health Sponsor:   Pamukkale University Completed
Source: - Category: Research Source Type: clinical trials
Condition:   Chronic Obstructive Pulmonary Disease Interventions:   Dietary Supplement: Fiber Inulin;   Dietary Supplement: Placebo Maltodextrin Sponsor:   Texas A&M  University Recruiting
Source: - Category: Research Source Type: clinical trials
Condition:   Chronic Obstructive Pulmonary Disease Intervention:   Behavioral: Advance directives Sponsor:   Centre Hospitalier René Dubos Recruiting
Source: - Category: Research Source Type: clinical trials
  Lockdown is a “prison like” experience, for Londoner Annabelle Ume, who suffers from myalgic encephalomyelitis. “It’s very similar to being trapped in a bunker with no access outside,” says Ume.   Many other fellow sufferers are enduring pandemic enforced isolation without much hope. “They are staying in limbo until help is available and adapting to the worsening of their health conditions,” says Ume. “You just try to make mental peace with it because the physical can’t be addressed at this time.” COPD sufferer John Linnell from Wisconsin i...
Source: EyeForPharma - Category: Pharmaceuticals Authors: Source Type: news
Abstract The development of chronic lung disease occurs as a consequence of multiple cellular events that involve an initial insult which often leads to the development of chronic inflammation, and the dysregulation of cellular proliferation and cell death mechanisms. Multiple cell types in the lung are key to the respiratory and protective/barrier functions necessary to manage the chronic exposures to environmental, mechanical, and oxidative stressors. Autophagy is essential to lung development and homeostasis, as well as the prevention and development of disease. The cellular process involves the collection and ...
Source: Mol Biol Cell - Category: Molecular Biology Authors: Tags: Prog Mol Biol Transl Sci Source Type: research
Conclusions: age is a determinant of worse prognosis among hospitalized patients with AECOPD.
Source: Internal and Emergency Medicine - Category: Emergency Medicine Source Type: research
AbstractAspergillus is a mold that may lead to different clinical pictures, from allergic to invasive disease, depending on the patient ’s immune status and structural lung diseases. Chronic pulmonary aspergillosis is an infection with a locally invasive presentation, reported especially in patients with chronic pulmonary disease, while aspergilloma is typically found in patients with previously formed cavities in the lungs. Aller gic bronchopulmonary aspergillosis is due to a hypersensitivity reaction toAspergillus antigens and is more frequently described in patients with moderate-severe asthma or cystic fibrosis. ...
Source: Infectious Diseases and Therapy - Category: Infectious Diseases Source Type: research
Annualized total medical expenditures are $ 7 billion and $ 5 billion, respectively
Source: Pulmonary Medicine News - Doctors Lounge - Category: Respiratory Medicine Tags: Family Medicine, Internal Medicine, Allergy, Emergency Medicine, Nursing, Pharmacy, Pulmonology, Journal, Source Type: news
In this study, a randomized cross-over trial was performed with 18 men diagnosed with COPD (FEV1 between 30% and 70% of its predicted value). Each participant randomly conducted two trials with 30 min of rest between them with the same protocol on a treadmill for 10 min at a constant rate of 50% of VO2peak. Each test was performed randomly and in a crossover randomized design in two different conditions: (1) oronasal breathing; and (2) nasal breathing with FB (nasal ventilatory flow restriction device). It was observed that FB had positive effects on dynamic hyperinflation, breathing pattern, and breathing efficiency, with...
Source: International Journal of Environmental Research and Public Health - Category: Environmental Health Authors: Tags: Article Source Type: research
CONCLUSION:  Telerehabilitation services can be regarded as an alternative to traditional rehabilitation approaches to reduce outpatient resource utilization and improve quality of life. However, more rigorous studies are suggested to investigate the effectiveness of telerehabilitation services for specific diseases or health conditions. PMID: 32629502 [PubMed - as supplied by publisher]
Source: Methods of Information in Medicine - Category: Information Technology Authors: Tags: Methods Inf Med Source Type: research
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