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.
Clinical analytics company Medial Earlysign Ltd. is expanding an existing partnership with Roche Holding AG to commercialize an artificial intelligence (AI) solution for the early detection of lung cancer. The companies originally signed an agreement in September to develop a personalized health solution for early detection of gastric cancer. The goal of the new collaboration is to develop Earlysign’s Lungflag software, which uses machine learning to identify patients at risk of developing lung cancer.
Two Israeli companies aiming to improve in vitro fertilization (IVF) success rates received good news recently, with Aivf Ltd. hauling in $25 million in a series A round for Ema, its IVF software platform, and Fairtility Ltd. gaining CE mark for its CHLOE EQ embryo quality decision-support tool.
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