FDA today designated a Philips recall of certain sleep and respiratory devices as Class I, its most serious level. Devices in the recall number in the millions, according to FDA’s database. There have been more than 1,200 complaints and more than 100 injuries involving polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. The foam has […]
Respiratory
The 18 most innovative medical devices of 2021
The Galien Foundation today announced the nominees for most innovative medical devices for its 15th annual Prix Galien USA Awards. The foundation nominates devices, biotechnology and pharmaceutical products for its annual Prix Galien awards to highlight products designed to improve the human condition. “The Awards Committee is excited to introduce the nominees for the 2021 […]
American Lung Association slams cigarette maker for inhaled medical therapy acquisition
The American Lung Association condemned the recently announced acquisition of Vectura by cigarette maker Philip Morris (NYSE:PM). Earlier this month, Philip Morris announced that it agreed to acquire inhaled drug delivery technology developer Vectura for $1.2 billion. In response to the acquisition, American Lung Association president & CEO Harold Wimmer and American Thoracic Society president Dr. Lynn Schnapp released a joint […]
Aerin Medical touts study of nasal airway obstruction treatment
Aerin Medical today touted results from a three-month study of its VivAer treatment for nasal airway obstruction (NAO). Sunnyvale, Calif.-based Aerin’s VivAer was studied in the VATRAC trial, with results published by the International Forum of Allergy and Rhinology. According to a news release, the study confirmed the safety and efficacy of VivAer in treating […]
Cigarette maker spending $1.2 billion on company with inhaled medical therapies
Philip Morris (NYSE:PM) announced today that it agreed to acquire inhaled drug delivery technology developer Vectura for $1.2 billion. New York-based Philip Morris agreed with the board of Vectura Group on the all-cash, recommended offer under which Vectura shareholders would be entitled to receive $2.07 per share (150 pence), representing a 46% premium to the ex-dividend closing […]
How bioengineers tackled the leaky mask problem
Researchers from Harvard and MIT have formed a company to mass-produce a more effective three-ply mask for everyday use. Anyone who wears glasses knows that the ubiquitous blue pleated mask leaks vapor upward, despite the wire designed to conform to the shape of the nose. Less obvious is the leakage from the mask’s sides and […]
FDA revokes EUAs for certain respirators, decontamination systems after increased N95 access
The FDA issued a briefing confirming the revoking of emergency use authorizations (EUAs) for certain respirators and decontamination systems. EUAs for all non-NIOSH (National Institute of Occupational Safety and Health)-approved disposable respirators, including disposable respirators like KN95s, along with decontamination and bioburden reduction systems, were all revoked, having been issued amid the COVID-19 pandemic. According […]
United Therapeutics touts study results for inhaled Tyvaso treatment
United Therapeutics (NSDQ:UTHR) today announced positive results from an analysis of forced vital capacity (FVC) change with its Tyvaso treatment. Research Triangle Park, N.C.–based United Therapeutics developed Tyvaso (treprostinil) as an inhalation solution for patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). The FDA approved the treatment in April 2020. Get the full story […]
Belluscura is back with an IPO in the U.K.
Belluscura last month filed for an initial public offering (IPO) more than three years after pulling its plans for going public in the U.K. The London-based company with U.S. headquarters in Plano, Texas, on May 24 confirmed an issue price of approximately $24.2 million (£17.5 million) for placing on the AIM market of the London […]
Teleflex completes respiratory asset sale to Medline
Teleflex (NYSE:TFX) announced that it completed the divestiture of a significant portion of its respiratory business to Medline Industries. Wayne, Pa.-based Teleflex announced last month that it agreed to sell a significant portion of its respiratory business to Medline for $286 million, reduced by $12 million of working capital to be retained by Teleflex. The […]
Teva launches first U.S. generic Perforomist inhaled COPD treatment
Teva Pharmaceuticals (NYSE:TEVA) announced the U.S. launch of the first generic version of the twice-daily Perforomist inhalation solution. Parsippany, N.J.-based Teva Pharmaceuticals — a U.S. affiliate of Tel Aviv, Israel-based Teva Pharmaceutical Industries Ltd. — launched the formoterol fumarate inhalation solution (20 mcg/2 mL) with an indication for treating bronchoconstriction in patients with chronic obstructive pulmonary […]
