The FDA is urging healthcare providers to use ventilator splitters for COVID-19 patients only when there is no alternative. The agency released a letter to providers asking them to consider non-invasive ventilation such as high-flow nasal oxygen or non-invasive positive pressure ventilation before resorting to a ventilator splitter. If a ventilator splitter is the only option, the […]
Respiratory
Electromed rises on Street-beating Q2
Electromed (NSDQ:ELMD) shares ticked up today on second-quarter results that topped the consensus earnings forecast. The New Prague, Minn.-based airway clearance therapy technology developer posted profits of $1.2 million, or 13¢ per share, on sales of $9.5 million for the three months ended Dec. 31, 2020, for a 1.6% bottom-line gain on sales growth of 11.1%. […]
FDA authorizes marketing of device to boost tongue muscles and reduce sleep apnea
The FDA announced today that it authorized the marketing of a device for reducing snoring and mild obstructive sleep apnea. The prescription-only device is used while awake to improve tongue muscle function, which can help prevent the tongue from collapsing backward and obstructing the airway during sleep. It is the first device of this kind […]
Ford designs clear mask to aid hearing-impaired
Ford Motor Company announced that it is ramping up new initiatives to help protect people from COVID-19, including mask development. Dearborn, Mich.-based Ford designed a patent-pending, clear respirator in the hopes of benefitting those with hearing impairments. It expects the respirator to certify to N95 standards of virus protection. The transparent, low-cost, reusable respirators allow […]
FDA grants EUA for CPAP filter to make devices safer around healthcare workers
Azimuth Sleep Solutions announced today that it received FDA emergency use authorization (EUA) for its PortPatch product. PortPatch, a patent-pending product, is designed to expand air filtration capabilities for patient treatment options and to keep healthcare workers safer in patient care areas in which non-invasive ventilatory treatment devices are in use. Memphis, Tenn.-based Azimuth Sleep […]
FDA clears lightweight Inovytec ventilators
Inovytec has announced that the FDA has granted FDA 510(k) clearance for its Ventway Sparrow ventilators. The 2.2 lb. transport and emergency ventilators had previously won FDA emergency authorization for use during the COVID-19 public health emergency. They are already commercialized in Europe, Canada and Australia and are undergoing registration procedures in other countries, according to […]
ResMed beats The Street on Q2 sales, disappoints on earnings
ResMed (NYSE:RMD) beat Wall Street analysts’ estimates for sales growth in its second quarter of 2021 but fell below their earnings projections. The San Diego-based company posted profits of $179.5 million, or $1.23 per share, on sales of $800 million for the three months ended Dec. 31, 2020, for an 11.8% bottom-line gain on sales growth […]
Abiomed skyrockets on Street-beating Q3
Abiomed (NSDQ:ABMD) shares shot up this morning on third-quarter results that topped the consensus forecast. Shares of ABMD were up 12.4% at $369.45 per share in early-morning trading today. The Danvers, Mass.-based oxygenation device maker posted profits of $61.9 million, or $1.35 per share, on sales of $231.7 million for the three months ended Dec. 31, […]
House committee investigates $70M federal contract for AutoMedx ventilators
A Congressional committee has launched an investigation into a $70 million White House contract for ventilators that reportedly are inadequate to treat people with COVID-19. The Department of Defense signed a $16.2 million contract in spring 2020 to buy SAVe II ventilators, manufactured by AutoMedx (Addison, Tex.), from the supplier Combat Medical Systems, according to the House Committee […]
FDA clears Aerobiotix system to clean air inside hospitals
Aerobiotix announced today that it received FDA 510(k) clearance for its Aerocure-MD medical air purification system. Miamisburg, Ohio-based Aerobiotix’s Aerocure-MD platform received FDA labeling to destroy microorganisms in the air by exposure to ultraviolet radiation and also remove particles in from the air via HEPA filtration, according to a news release. Aerocure-MD is designed for […]
Inogen names new CEO
Inogen (NSDQ:INGN) announced that it appointed Nabil Shabshab to serve as its new CEO, effective on Feb. 8, 2021. Additionally, according to a news release, on Jan. 22, Inogen’s board appointed Shabshab to serve as a Class II director of the company, effective Feb. 8, too. His term will expire at the annual meeting of stockholders […]
