Beyond Air Inc. completed a senior secured debt financing of up to $40 million from Avenue Capital Group to support the company’s commercial launch of the Lungfit PH and further development of the Lungfit platform. Beyond Air is focused on applications of nitric oxide for the treatment of patients with a range of respiratory conditions. Its affiliate, Beyond Cancer Ltd., is developing a treatment for solid tumors that uses an ultra-high concentration of nitric oxide.
Biosency SAS recently unveiled the latest results on its predictive digital medical device for remote monitoring of patient suffering from chronic obstructive pulmonary disease (COPD). The Bora platform demonstrated its ability to predict COPD exacerbation on average three days prior to hospitalization.
Another brick in the ambitious Human Cell Atlas initiative has been put into place with the publication of the largest and most comprehensive cell map of the human lung. The open and freely available atlas catalogs the diversity of cells in the lung, including rare and previously undescribed cell types.
Biosency SA's Bora Care remote monitoring solution can predict acute chronic obstructive pulmonary disease (COPD) exacerbations on average three days prior to hospitalization, according to initial results from an ongoing study. The results show that the technology can help prevent hospital admission and reduce the severity of acute exacerbation of COPD (AECOPD) leading to a better quality of life for COPD patients.
The U.S. FDA has approved Polarean Imaging plc’s drug-device combination product, Xenoview, for use with magnetic resonance imaging (MRI) in evaluating lung ventilation in adults and children aged 12 and older. The hyperpolarized contrast agent, which is prepared from the Xenon Xe 129 gas blend, is expected to be commercially available in the U.S. starting next month.
U.S. federal authorities have made a lot of noise over inappropriate medical testing in the past two years, largely due to the COVID-19 pandemic, but Paul Garcia, a partner in the San Diego office of Hooper, Lundy & Bookman PC, says this trend will not ebb at all in the coming year. Garcia told BioWorld that the lookback period for Medicare testing claims runs several years and that not only will enforcement results continue to surface next year, but also that the associated civil monetary penalties could force a testing lab to shutter its operations permanently.
The U.S. FDA posted an update to the ongoing recall of respirators and positive airway pressure devices by Philips Respironics Inc., a subsidiary of Amsterdam-based Royal Phillips NV, which are associated with more than 21,000 medical device reports (MDRs) between Aug. 1 and Oct. 31, 2022. However, these MDRs are also associated with 91 patient deaths, which while they cannot be attributed directly to these devices, are nonetheless a stain on the reputation of the company’s products going forward.
The FDA granted Adherium Ltd. 510(k) clearance for its next-generation Hailie sensor that connects with Glaxosmithkline plc’s Ellipta inhaler to enable monitoring of medication use for asthma and chronic obstructive pulmonary disorder (COPD).
Investors are backing neurostimulation device company Stimdia Medical Inc. with $16 million, in the first tranche of a series B offering expected to total $30 million. The Minneapolis-based company is developing a device that stimulates the phrenic nerves in a patient’s neck to exercise the diaphragm during mechanical ventilation and minimize ventilation-induced diaphragmatic dysfunction (VIDD).
The U.S. FDA has given Resapp Health Ltd. the green light for its 510(k) Sleepcheckrx app to detect moderate to severe sleep apnea in adults as a prescription-only software-as-a-medical device. The FDA cleared the app as a class II medical device. Brisbane, Australia-based Resapp submitted the 510(k) premarket notification to the FDA in November 2021 for Sleepcheckrx for at-home sleep apnea screening.
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