Amid the COVID-19 pandemic sweeping the globe, President Donald Trump issued an executive order to increase the availability of personal respiratory devices for healthcare workers. In a memorandum released by the White House on March 10, Trump declared that public health experts anticipate shortages in the supply of respirators available for use by healthcare workers […]
Respiratory
FDA asks manufacturers to help prevent protective gear shortages
The FDA said today it wants to hear from surgical mask and gown manufacturers that might be able to increase or speed production to prevent shortages in the U.S. during the COVID-19 outbreak. The agency said it may expedite review of manufacturing site changes or premarket submissions of personal protective equipment, including protective clothing, gowns, […]
FDA clears Fluidda’s high-res respiratory imaging software
Fluidda (Los Angeles) said today that the FDA has cleared its Broncholab software designed to to assist in diagnosing and monitoring of respiratory diseases for clinical use. The Broncholab platform can provide a number of functional respiratory imaging (FRI) parameters to physicians via an online platform, according to the company. FRI combines high-resolution computed tomography, […]
Electromed launches SmartVest mobile app
Electromed (NSDQ:ELMD) announced that it launched the SmartVest Connect app for personalized high-frequency chest wall oscillation (HFCWO) therapy management for people with compromised pulmonary function. The app, available on iOS and Android platforms, is designed to securely connect to the SmartVest SQL through Bluetooth technology and allow patients and healthcare teams to track therapy in real-time […]
Report: Some hospitals running short of 3M’s N95 masks amid coronavirus outbreak
Some U.S. hospitals are facing short supplies of N95 respirator masks from 3M (NYSE:MMM) as the global coronavirus outbreak ramps up, according to a report in The New York Times. “I can tell you my other colleagues across our multiple hospitals are really rationing,” Dr. Susan Ray, an infectious disease specialist at Grady Memorial Hospital in […]
U.S. lifts tariffs on certain medical supplies to prevent spread of coronavirus
U.S. trade officials recently exempted more than 100 medical items manufactured in China from import tariffs in an effort to fight the coronavirus outbreak, according to published reports. Cardinal Health and Medline Industries were among 27 companies with certain products that had their 7.5% tariffs lifted. Exempted products included protective masks, drapes and gowns, hand […]
Could Altair Medical’s wearable reduce opioid deaths?
Altair Medical announced that it won FDA breakthrough device designation for its Respmeter wearable biosensor device for opioid-induced respiratory depression (OIRD). Glasgow, Scotland–based Altair Medical’s Respmeter is a chest-worn wireless sensor designed to detect OIRD, a common side effect of using opioid drugs. The Respmeter monitors and analyzes respiratory patterns by using proprietary algorithms. Once […]
FDA authorizes industrial respirators for use during coronavirus
The FDA has authorized the use of certain industrial respirator masks for healthcare workers during the coronavirus outbreak. The N95 disposable filtering facepiece respirators have been approved by the National Institute for Occupational Safety and Health (NIOSH) as non-powered air-purifying particulate respirators. Healthcare workers will be allowed to use these, including those that have passed […]
Masimo gains FDA clearance for new respiration rate measurement system
Masimo (NSDQ:MASI) said today that the FDA has granted 510(k) clearance to its continuous RRp (respiration rate from the photoplethysmograph) monitoring of adult and pediatric patients with Rad-97, Radical-7, and Radius-7 Pulse CO-Oximeters. With this clearance, both continuous and spot-check RRp are now available in the U.S., supported in a variety of pulse oximetry sensors and […]
Inogen reports Q4 misses, reduced guidance
Inogen (NSDQ:INGN) shares skyrocketed today on fourth-quarter results that missed the consensus earnings forecast but beat The Street’s sales projections. The Goleta, Calif.-based home oxygen generator maker posted losses of -$1.4 million, or -6¢ per share, on sales of $78.9 million for the three months ended Dec. 31, 2019, sliding into losses after posting profits […]
Tytek Medical recalls TM-317 PneumoDart pneumothorax needles
Tytek Medical issued a recall for its PneumoDart pneumothorax needles for air removal during life-threatening situations like lung trauma or collapse. According to an FDA news release, the recall, which Tytek Medical initiated on Nov. 18, 2019, is now considered a Class I recall, the most serious kind. The PneumoDart needle is designed to remove […]