The FDA has released enhanced recommendations on the production and disinfection of reusable medical devices, according to a press release.
GlaxoSmithKline has received approval from the Japanese Ministry of Health, Labour and Welfare for Encruse Ellipta to treat COPD. The drug has already been approved in the US and Canada under the trade name Incruse Ellipta.
Nihon Kohden has procured a group purchasing agreement for physiological monitoring with Premier Inc, a leading healthcare improvement company representing 3,400 US hospitals and 110,000 other providers.
The Portex Blue Line Ultra tracheostomy tubes with thin-walled inner cannulae allow increased respiratory airflow and help improve the patient’s work of breathing while maintaining patency and airway hygiene.
Two FDA advisory committees have voted 16 to 4 in favor of approving Breo Ellipta for the treatment of asthma in adults aged 18 years and older.
Last fall, GE Healthcare released its newest critical care ventilator to European markets, the Carescape R860. The ventilator uses advanced lung protection tools and an intuitive touchscreen interface to help improve patient care.
Breo Ellipta, a respiratory medicine for COPD, failed to show any safety concerns when used to treat asthma per a preliminary FDA review but faces added scrutiny to assess its safety.
Arch Biopartners has identified a new drug candidate to treat Pseudomonas aeruginosa respiratory infections and intends to move forward with a human trial this year to test its safety.
Merck announced new data evaluating KEYTRUDA, an anti-PD-1 therapy, in advanced non-small cell lung cancer and malignant pleural mesothelioma.
The top ten finalists for the biannual Innovative HME Retail Product Awards have been named, according to a Medtrade news release.
Dieter Kirsch developed a system for his son with cystic fibrosis that analyzes his nebulizer use with a video game.
AstraZenaca's investigational COPD drug PT003 hit its main goals in two late-stage trials, clearing the way for regulatory filings this year in the US and EU.
Mediware's Cardiac and Pulmonary Rehab solution helps support the CMS readmission reduction program, specifically related to COPD.
Apple has introduced ResearchKit, an open source software framework designed for medical and health research.
Maquet Medical Systems USA has signed an exclusive distribution agreement with Flight Medical to distribute the Flight 60 mechanical ventilator, Flight Medical’s flagship product.
The HAMILTON‐MR1 ventilator is now equipped with a CE-approved Neonatal Option, which means the device can now provide optimal ventilation therapy during MRI procedures for all patient populations.
Actavis has launched its generic version of AstraZeneca’s Pulmicort Respules after a US District Court judge in New Jersey denied AstraZeneca’s request for a permanent injunction and invalidated its patent.
Cumberland Pharmaceuticals has received clearance from the FDA to complete a study of Boxaban, which could be used to treat aspirin-exacerbated respiratory disease (AERD).
Theravance and Mylan will partner to develop and commercialize their COPD drug, TD-4208.
Celtaxsys, Inc, a clinical stage biotechnology company, announced that the FDA has granted orphan drug designation to its cystic fibrosis treatment drug leukotriene A4 hydrolase inhibitor.