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.

The first filing from Cancerrisk AI Inc. describes their development of a system that uses deep learning to predict future cancer risk from a biopsy image.

Inbrain Neuroelectronics SL closed a $50 million series B financing round to advance clinical trials for its graphene-based brain-computer interface therapeutics platform. The company also secured additional funding from Merck KGaA GmbH which will go towards developing the technology for application across both central and peripheral nervous systems.

In what represents the first patenting from Eyecheq Inc., the company is seeking protection for its self-guided eye examination systems which may be mounted in easily movable and transportable kiosks, on tabletop stands, walls or suspended from ceilings.

Mobile health platform company Helfie AI has partnered with Microsoft to offer Microsoft enterprise customers the ability to license Helfie’s cutting-edge health assessment tools directly through the Microsoft Azure Marketplace.