Beyond Air Inc. completed a senior secured debt financing of up to $40 million 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 ultra-high concentration nitric oxide.

Avenda’s AI-powered prostate cancer mapping tool outperforms standard care in independent study

Avenda Health Inc. reported new study results showing its Unfold AI platform, which uses artificial intelligence (AI) to map a tumor’s location within the prostate, encapsulates all of the clinically significant cancer present in the gland more effectively than standard care. The retrospective study, led by researchers at Stanford University School of Medicine’s Department of Urology, involved a dataset of 50 consecutive patients who underwent radical prostatectomy for intermediate-risk cancer. Unfold AI’s deep learning model incorporated biomarker, biopsy and imaging features to create 3D cancer estimation maps and margins. When compared with conventional margins produced by MRI, the rate of complete encapsulation of clinically significant prostate cancer was markedly higher – 80% vs. 56%.

Sonex Health presses FDA to avoid down-classification of SX-One device

The U.S. FDA’s citizen’s petition process doesn’t always yield the desired outcome, but the agency must nonetheless respond to these petitions. Sonex Health Inc. has petitioned the FDA to rethink a proposal to reclassify the company’s SX-One device for treatment of carpal tunnel syndrome, an unusual instance in which a medical device maker has resisted a proposal to make a device exempt from regulatory requirements. Perhaps the most conspicuous recent example of a citizen’s petition is that filed by the CDS Coalition regarding the FDA’s final guidance for clinical decision support software.

IA Medical raises $1.5M to develop a Chatbot to support caregivers and Alzheimer's patients

IA Medical SAS has just raised $1.5 million to accelerate the development of its Alix Chatbot, designed to support and make life easier for caregivers of patients suffering from Alzheimer's disease. The Klesia GIE investment fund, which depends on Agirc-Arrco GIE, the administrator of the French private-sector pension scheme, and the French sovereign bank BPIFrance SA contributed 46.42% of the financing. More than half of this financing corresponds to an opening of IA Medical SAS's capital to individual partners, including doctors. "Thanks to this fund-raising, we'll be able to develop ever more innovative tools to make life easier for caregivers and optimize support for people suffering from Alzheimer's disease," says Lydie Catalano, co-founder and CEO of IA Medical SAS.

General Stim’s implanted sacral nerve stimulation approved in China

General Stim Inc.’s implanted sacral nerve stimulation (SNS) system was approved in China to treat individuals with certain bladder and bowel conditions. Hangzhou-based General Stim’s SNS system consists of a sacral nerve stimulator, an extension lead and an electrode. “The system can generate multiple electrical pulse stimulation through the six contactors. and the stimulator parameters can be adjusted and controlled at a distance,” the company told BioWorld.

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