South Korea’s Ministry of Food and Drug Safety cleared Acryl Inc.’s Acryl-D01 as the country’s first AI-based digital therapeutic software solution to aid depression screening and diagnosis on Dec. 20. Approved as a class II software as a medical device, Acryl-D01 utilizes a patient’s medical records to quantify and analyze the individual’s emotional response and assess the probability of having clinical depression based on the data.

The FDA’s final guidance for predetermined change control plans (PCCPs) for AI products contains a number of editorial changes, some more significant than others.

The recent $73 million raised by Cradle NV in a series B financing round will allow the company to build out its operations and improve its artificial intelligence-powered protein engineering platform.

The U.K.'s Medicines and Health Care Products Regulatory Agency chose five technologies for its AI Airlock pilot program as it looks to understand the best way to regulate artificial intelligence-powered medical devices so that they can be safely deployed across the national health service.

At long last, the U.S. FDA finalized guidance on using predetermined change control plans in submissions for medical devices that include artificial intelligence. The guidance, “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions,” aims to support the iterative improvement central to many algorithms while minimizing potential issues with safety and efficacy.

Mica AI Medical Ltd. is looking to transform the early diagnosis of breast cancer with its software which helps radiologists analyze mammograms more effectively. The company recently signed a collaboration and licensing agreement with Baptist Health South Florida in a bid to bring its technology to the U.S. market.

An artificial intelligence-powered contactless monitoring device developed by Albus Health Ltd. can detect signs of asthma attacks in children up to five days before they occur.

On the heels of U.S. FDA approval for Neurophet Aqua, an updated version of its artificial intelligence (AI)-based magnetic resonance imaging analysis software for the brain, Neurophet Inc. is preparing for an IPO in 2025 and expansion into U.S. and European markets.

The first filing to emerge from Identifyher Ltd. seeks to gain protection for a wearable sensor that women can wear daily to track potential symptoms of perimenopause, providing them with data that can be used to find the right management plan for their needs.

For Inocras Inc., the benefits of whole genome sequencing are two-fold. First is its explicit usefulness in diagnosing and treating hard-to-treat diseases like cancer and rare diseases. The second, less apparent, benefit lies in the data generated in the process, and its applications to current and future generations of cancer patients.