The Hamilton-T1 transport ventilator is now approved in the EU with a neonatal option, according to the company.
Arnuity Ellipta (fluticasone furoate inhalation powder) is a once-daily ICS for maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older.
A White House department reportedly edited language in the FDA’s proposed rules for tobacco products that may weaken and limit the agency’s ability to regulate e-cigarettes and cigars, according to published documents cited by a Reuters news article.
Kimberly-Clark Corp has filed a Form 10 Registration Statement with the SEC to spin-off its Kimberly-Clark Health Care business and rebrand it Halyard Health Inc, which would be based in Alpharetta, Ga.
Flight Medical Innovations Ltd has received FDA 510(k) clearance for its Flight 60 ventilator integrated O2 mixer version, and three advanced ventilation modes, according to a company announcement.
The FDA has proposed a new rule that would extend the agency’s tobacco authority to regulate additional tobacco products, most notably electronic cigarettes (e-cigarettes), cigars, and other popular alternatives to cigarettes.
Spacelabs Healthcare is recalling the Arkon Anesthesia System with Version 2.0 Software due to a software defect that may cause serious adverse health consequences, including hypoxemia and death, according to an FDA announcement.
Grastek, a sublingual allergen extract manufactured by Merck & Co Inc, has received FDA approval as an immunotherapy for the treatment of Timothy grass pollen-induced allergic rhinitis.
Health Care Service Corporation will begin covering FeNO testing for asthma diagnosis and management effective April 1, 2014, according to a press announcement by Aerocrine.
Doribax (doripenem), an antibacterial drug that has been used to treat patients who develop pneumonia while on ventilators, carries an increased risk of death and lower clinical cure rates compared to similar antibacterial drugs, according to the FDA.