TORONTO – What do ER doctors want most for their patients? Never to return to the ER, said Giovanni Ferrara, a professor at Edmonton’s University of Alberta Hospital's Division of Pulmonary Medicine. Ferrara is heading a feasibility project to see if a wearable device developed by Rochester, N.Y.-based Heath Care Originals Inc. can predict with scientific certainty when the condition of a patient with lung disease is worsening and requires another visit to the hospital.
Synapse Biomedical Inc. has won breakthrough device designation from the FDA for its Transaeris system, a diaphragm pacing system (DPS) for use in weaning patients off mechanical ventilation. The minimally invasive device has been in use during the COVID-19 pandemic under an emergency use authorization to prevent ventilator-induced diaphragm dysfunction – a condition that occurs following mechanical ventilation, which leaves the diaphragm weak from disuse.
It’s more than 20 years since the tobacco firm Philip Morris International Inc. commissioned a controversial research paper, “Public Finance Balance of Smoking in the Czech Republic,” which infamously argued that smokers cut state health care expenditure by dying early. The paper was considered an outrage and led to a high-profile apology from the company, after being widely derided by politicians and commentators internationally. The company’s July 9 proposal to buy the respiratory diseases firm Vectura Group plc for $1.2 billion is already looking just as provocative according to U.K. politicians and anti-smoking groups, who are calling for the government to intervene to stop it going ahead.
Steven Roy, CEO of Convergence Medical Sciences Inc., has designed a low-cost device that boosts the number of patients on a single ventilator to four simultaneously. To do this, he is collaborating with Calgary-based consulting engineers, Exergy Solutions Inc., to take the international Red Dot design winner through the Health Canada approval process.
Almost 11 years to the day after first gaining FDA clearance, the Sonarmed airway monitoring system finally launched on a commercial scale in the U.S. The new rollout appears likely to revive the product’s prospects as it comes with significantly increased financial backing and deep connections to hospitals as a result of Sonarmed’s acquisition by Medtronic plc in December 2020. The system, which uses acoustic technology to identify endotracheal tube obstruction and verify proper tube positioning in neonates and infants who require invasive mechanical ventilation, has been implemented in a small number of hospitals to date.
The management team at Respinova Ltd. is breathing easier with the FDA's 510(k) clearance of the company's Pulsehaler. Using pulsed air pressure, the device opens airways and clears secretions in patients with respiratory diseases. The clearance represents the device’s first endorsement by a regulatory agency, though the company hopes it will soon be joined by others.
Teleradiology company Nines Inc. won 510(k) clearance from the FDA for Ninesmeasure, an artificial intelligence (AI)-powered tool for measuring lung nodules. The Palo Alto, Calif.-based company says the new tool can help speed the diagnosis of certain respiratory diseases, resulting in better patient outcomes.
PERTH, Australia – With a fresh injection of A$28.9 million (US$22.4 million) in grant funding from the Australian government and a capital raise of A$40 million, 4dmedical Ltd. is well on its way to commercializing its first lung imaging product in the U.S. and Australia. 4dmedical’s X-ray velocimetry (XV) technology is the first FDA-cleared respiratory imaging solution that uses mathematical models and algorithms to convert sequences of X-ray images into four-dimensional quantitative data.
The U.S. FDA has granted emergency use authorization (EUA) to Breath Direct Inc. for its BDR-19 critical care ventilator for the treatment of critical care patients with respiratory insufficiency. Initial shipments of the device are expected within weeks. The EUA marks a major milestone for the fledgling Long Beach, Calif.-based company, which was started by medical device entrepreneur Darren Saravis in the early days of the pandemic.
MIT Media Labs spinoff Empatica Inc. secured the CE mark for its Aura system, a wearable solution for the monitoring and early alert of respiratory infections, including COVID-19. For use with people 14 and older, Aura is commercially available in Europe and the U.K., and for pilot purposes in the U.S. – pending FDA authorization. Aura’s algorithm analyzes vital signs from Empatica smartwatches, comparing data against the wearer’s historical baselines. In validation studies, Aura was able to detect patients with possible H1N1 influenza, rhinovirus or SARS-CoV-2 infection with 0.94 sensitivity. Detection occurred on average two days after infection.
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