Thirona BV has been awarded $2.73 million in funding from the European Innovation Council (EIC) to fast-track the development of its artificial intelligence (AI)-based lung platform to analyze chest CT imaging. In competition with 554 other submissions, Thirona was one of 51 innovative technology companies awarded the EIC accelerator program grant, the total budget for which is €261 million (US$286.28 million) in 2023.
Resmed Inc. has acquired Somnoware Inc., a privately held developer of respiratory care diagnostics software, for an undisclosed price. The deal is Resmed’s third software acquisition in the past year, having snapped up German software-as-a-service (SaaS) maker Medifox Dan GmbH for $1 billion in June 2022 and Mementor GmbH last August.
Luminopia Inc. reeled in $16 million in an oversubscribed series A financing led by U.S. Venture Partners. The funds will support full commercial launch of the company’s U.S. FDA-cleared digital therapeutic for the treatment of children ages 4-7 with amblyopia. “We are thrilled to announce the successful close of our oversubscribed series A round, which will allow us to advance our mission of pioneering a new class of treatments for the 15 million Americans who suffer from neuro-visual disorders,” said Scott Xiao, Luminopia’s co-founder and CEO.
Makers of dental equipment don’t typically show up on the U.S. FDA enforcement radar screen, but the introduction of biologics and software into routine dental practice has upped the regulatory stakes. This can be seen in the June 20, 2023, warning to Vitang Technology LLC, of Tustin, Calif., which cited the company for failure to validate a change of software used in orthodontic treatment planning systems, but the FDA reinforced the notion that claiming that the agency approved or cleared the device is also a violation of the Code of Federal Regulations.
The U.S. FDA’s September 2022 guidance for clinical decision support (CDS) software was controversial the moment the agency posted the document, prompting the filing of a citizen’s petition five months later. The CDS Coalition has penned a June 8 letter to FDA commissioner Robert Califf in an effort to draw a reaction from the agency, but the letter was accompanied by a summary of an analysis of CDS software with a machine learning (ML) component that suggests that such products that are in development may have to be reconsidered.
The U.S. FDA has given the greenlight to Sparrow Acoustics Inc. (dba Sparrow Bioacoustics) for its Stethophone, a software-based technology that allows doctors and nurses to check a patient’s heart and lung sounds using a smartphone. Providers simply hold the smartphone against the patient’s chest to listen for possible abnormalities.
Aural Analytics Inc. received a breakthrough device designation from the U.S. FDA for its Speech Vitals-ALS technology, a software application that collects and analyzes speech recordings to help monitor amyotrophic lateral sclerosis (ALS) in adults in clinic and home settings. The software could improve management of the devastating disease.
Nervtex Co. Ltd.’s diagnostic assessment software Modas for movement disorders such as Parkinson’s disease has been given NMPA approval in China. Using smart mobile devices, Modas can process video data collected from people with potential or existing movement disorders when they are in any specific motion state.
Reflexion Medical Inc. entered into a nonexclusive worldwide licensing agreement with Mirada Medical Ltd., allowing Mirada’s Redengine image registration algorithms to be integrated into Reflexion’s X1 treatment planning software. The algorithms align a patient’s anatomy between distinct imaging modalities or between radiotherapy treatments.
Infervision Medical Technology Co. Ltd. received approval from China’s NMPA for its radiological computer-assisted triage and notification software device Inferread CT Stroke. This is the first class III approval that the firm obtained in the cerebro-cardiovascular field. Class III approvals are for high-risk medical devices.
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