Patients and investors in Alung Technologies Inc. can breathe a little easier now that the company’s Hemolung respiratory assist system has won a de novo approval from the FDA. The FDA approval comes more than eight years after Hemolung received CE mark and Health Canada approval. Hemolung gained FDA emergency use authorization for patients with COVID-19 in April 2020.
Natera Inc. added its Prospera assessment for lung transplant patients to its portfolio, joining the company’s tests for rejection of kidney and heart transplants. The test uses donor-derived cell-free DNA (dd-cfDNA) to detect acute rejection as well as chronic rejection and infection in stable patients. Results of the VALID study presented at CHEST 2021 demonstrated that the Prospera Lung test had a negative predictive value of 97.33%, sensitivity of 89.06% and area under the curve of 0.91.
After nearly two years of waiting, Withings SA won FDA clearance for its Scanwatch, a smartwatch that can take an electrocardiogram and monitor for sleep disturbances indicative of sleep apnea or respiratory illnesses such as chronic obstructive pulmonary disease. The FDA action makes the watch the first cleared for both functions.
Broncus Holding Corp.’s shares tumbled more than 20% on its first trading day on Friday, Sept. 24, in Hong Kong. It raised HK$1.55 billion (US$199.1 million) at HK$18.70 a share, the top end of its target range. Nearly half of the proceeds will be used for the R&D and commercialization of its two core interventional pulmonology products: the Intervapor system and the RF Generator + RF Ablation Catheter (RF-II).
A multicenter study has found that a multiplex diagnostic panel developed by Opgen Inc. can reduce the use of inappropriate antibiotic therapy by 45.1%. Opgen’s Unyvero Hospitalized Pneumonia (HPN) panel uses PCR technology that can detect 21 pathogens and 17 antibiotic resistance markers in less than five hours. During the European Respiratory Society conference, Rockville, Md.-based Opgen presented data showing that combined with antibiotic stewardship, its HPN panel decreased time on inappropriate antibiotic therapy in hospitalized patients with pneumonia at risk for Gram-negative rods.
LONDON – Breath biopsy specialist Owlstone Medical Ltd. closed a $58 million oversubscribed series D, bringing the total raised by the company since its formation in 2016 to over $150 million. The money will support further development of tests for lung cancer, liver disease and respiratory disease, and of a new class of diagnostics, which rather than measuring endogenous markers of disease, involve administering chemical probes and assessing how they are metabolized.
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.
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