Officials at GE Healthcare (NYSE:GE) think the company’s new Thoracic Care Suite — a collection of eight AI algorithms from Lunit Insight CXR — could help clinicians in the fight against COVID-19. The AI suite, launched today, quickly analyzes chest X-ray findings and flags abnormalities for radiologist review, according to GE. It can spot potential pneumonia […]
Respiratory
Inspire Medical wins coverage from Cigna
Inspire Medical Systems (NYSE:INSP) has announced that Cigna will provide insurance coverage for the company’s Inspire obstructive sleep apnea therapy beginning this week. Cigna insures approximately 16 million members in the U.S., the minimally invasive sleep apnea treatment developer noted. The addition of Cigna brings the total of insurance policies covering Inspire to 54, representing over […]
CAE receives Health Canada nod for CAE Air1 ventilator
CAE (NYSE:CAE) announced today that its CAE Air1 ventilator received certification from Health Canada and is set to treat people with COVID-19. Two months ago, the Canadian government issued a contract to CAE to manufacture and supply 10,000 ventilators amid the COVID-19 pandemic. The devices deliver pressure control, volume control and pressure support ventilation using […]
States reportedly fend for themselves with inflated ventilator prices
States had to scramble to obtain ventilators after the White House left them to fend for themselves, according to a Kaiser Health News report. Demand for intensive care unit ventilators skyrocketed as healthcare facilities dealt with the surges of COVID-19 patients over the course of the pandemic, which still goes on today after gaining steam […]
Chinese company faces federal charges in ‘fake’ N95 respirator case
A Chinese manufacturer has been charged with producing and exporting to the United States nearly half a million misbranded and defective masks that falsely purported to be N95 respirators, the federal government reported. King Year Packaging and Printing Co. Ltd. (King Year) faces three counts of violating the Federal Food, Drug and Cosmetic Act (FDCA) […]
3M sues seller of fake and damaged N95 respirators
3M (NYSE:MMM) announced that it filed a legal action in federal court alleging that a seller on Amazon inflated prices of fake, defective and damaged N95 masks. N95 masks have been in high demand as the COVID-19 pandemic roars on. In April, the U.S. Defense Dept. awarded a $76 million contract to 3M to produce the respirators […]
BioMedInnovations gains EUA for ventilator
BioMedInnovations announced today that it received FDA emergency use authorization (EUA) for its SuppleVent ventilator technology. With the EUA, the SuppleVent system becomes the latest alternative ventilator to gain some form of authorization to assist during the COVID-19 pandemic. Denver, N.C.-based BioMedInnovations’ proprietary back-pressure regulator (BPR) technology was designed in collaboration with Lawrence Livermore National […]
Inspire Medical names former Abbott CTO as new COO
Obstructive sleep apnea therapy developer Inspire Medical Systems (NYSE:INSP) announced today that it appointed industry veteran Phil Ebeling as its new COO. The company’s new COO is taking on responsibilities including oversight and leadership of operations, quality assurance, clinical research, regulatory affairs and business development activities, according to a news release. Ebeling most recently served as […]
Nuvaira gains FDA breakthrough nod for lung denervation system
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 […]
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 […]