Obstructive lung disease treatment developer Nuvaira said today that the FDA has designated its lung denervation system a breakthrough device. The Nuvaira lung denervation system enables a novel bronchoscopic procedure that disrupts pulmonary nerve input to the lung to reduce the clinical consequences of neural hyperactivity, which causes airway hyper-responsiveness or “lung attacks” in both COPD […]
Respiratory
FDA restricts re-use of certain respirators for COVID-19
Certain respirators made in China and respirators with exhalation valves should not be decontaminated for re-use by healthcare workers, the FDA announced today. The agency revised these respirators’ emergency use authorizations (EUAs) to reflect the changes. The particular respirators from China “may vary in their design and performance,” the FDA said, basing its decision on […]
Respira Technologies seeks drug candidates for its nebulizer
Respira Technologies (West Hollywood, Calif.) announced the launch of a pharmaceutical-focused commercial development program for its RespiRx drug-delivery device platform. RespiRx is a portable, handheld vibrating mesh nebulizer designed for local and systemic treatment and can operate in any position held by the patient. Current-generation nebulizers are gravity-fed, which limits usage and can lead to improper […]
NASA, Fitbit gain EUAs for COVID-19 devices
The FDA granted emergency use authorization (EUA) for emergency COVID-19 ventilator devices developed by Nasa and Fitbit (NYSE:FIT). According to the FDA’s ongoing list of devices granted EUAs, both devices were authorized on June 1. NASA’s VITAL (ventilator intervention technology accessible locally) compressor and the Fitbit Flow are the latest of a few ventilator alternatives to […]
Battelle under fire for decontamination system performance
Major media outlets are questioning the ability of the Battelle Critical Care Decontamination System (CCDS) to safely reprocess used N95 respirators up to 20 times, as the company has claimed. The FDA granted the nonprofit tech development company an emergency use authorization in March for its vaporized hydrogen peroxide system to decontaminate N95 respirators used […]
U of M releases Coventor ventilator design as open-source
The University of Minnesota recently announced that it released the design for its Coventor alternative ventilator as open-source. Minnesota’s Coventor low-cost device gained notoriety in March after researchers touted the design made from various parts totaling just $150. In April, it became the first ventilator of its kind authorized for use under the FDA’s EUA […]
ALung Technologies raises $2m
ALung Technologies filed an SEC Form D to confirm the sale of $2 million in debt, options, warrants and other rights to purchase securities. The Pittsburgh-based company made its first sale in the new notice on May 20 and reached its offering total of $2 million by June 1. Just one investor participated in the […]
Medtronic is making its ‘artificial lung’ therapy available for COVID-19 treatment
Medtronic (NYSE:MDT) is temporarily modifying product indications so that health providers can use its extracorporeal membrane oxygenation (ECMO) technology to treat people with severe cases of COVID-19. ECMO could be described as a type of “artificial lung” technology that pumps blood from a person’s body to an oxygenator that provides long-term oxygen and carbon-dioxide transfer. Medtronic […]
Vexos to manufacture 10,000 ventilators for Canadian COVID-19 patients
Electronics manufacturer Vexos said this week that it has signed an agreement with the government of Canada to manufacture 10,000 mechanical ventilators for COVID-19 patients in that country. The LaGrange, Ohio-based company said it will build the ventilators, known as Mechanical Ventilator Milano (MVM), under an exclusive license agreement with Elemaster Group for the Americas. […]
Texas-based team seeks EUA for 3D printed emergency ventilator
A team of physicians and engineers developed a hands-free resuscitator bag compression device that can be utilized as an emergency ventilator during the COVID-19 pandemic. As the pandemic goes on and a shortage of vital equipment, including ventilators, continues, a number of companies and research teams from all over have worked to create alternative options. […]
MIT researchers may have invented a safer way of splitting ventilators
MIT and Brigham and Women’s Hospital researchers say they have a way of splitting ventilators which could address many of the safety concerns — potentially boosting the supply of ventilators amid the COVID-19 pandemic. They have demonstrated their concept’s effectiveness in the lab — but they still caution it should be used only as a last resort […]