Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ava, Bactiguard, Nyxoah, Soundbite Medical.
Hologic Inc. is teaming up with Google Cloud to use machine learning technologies to improve the accuracy and timeliness of cytology for cervical cancer screening. Marlborough, Mass.-based Hologic, which makes both Pap and human papillomavirus (HPV) assays, is already using artificial intelligence (AI) and machine learning in its new digital cytology platform that is available in Europe. The multiyear collaboration with Mountain View, Calif.-based Google Cloud will start with innovating that product further by enhancing the deep learning component of the system.
PARIS – Four years after being set up in Marseilles, France, Volta Medical SAS reported raising $28 million in a series A round for the VX1 software mapping system, an artificial intelligence (AI) algorithm that is compatible with most readily available multipolar catheters and technology used in operating rooms and cath labs to treat cardiac arrhythmia.
The U.S. FDA granted 510(k) clearance for Clew Medical Ltd.’s artificial intelligence (AI)-based solution that can predict hemodynamic instability in ICU patients eight hours in advance of deterioration. The system continuously monitors and stratifies patients by risk level to enable optimization of ICU resources.
Novasignal Corp. has a launched a cloud-based app to provide alerts to clinicians directly from its cerebral ultrasound device. The new app allows physicians to get instant notifications from the company’s Novaguide device, a transcranial doppler ultrasound technology that allows for real-time assessment of blood flow in the brain by combining robotics and artificial intelligence (AI).
HONG KONG – Earlysense Ltd. has sold a contact-free continuous monitoring technology to global med-tech provider Hillrom Holdings Inc. Ramat Gan, Israel-based Earlysense will receive licensing for all intellectual property and technology sold to Chicago-based Hillrom for use outside the hospital along with $30 million in cash, commercial milestone payments and a portion of Hillrom's equity investment
PERTH, Australia – Wellington, New Zealand-headquartered Volpara Health Technologies Ltd. has acquired Boston-based CRA Health LLC for $18 million up front and an additional $4 million to be paid over the next 18 months in earnouts. Volpara’s digital health solutions use imaging and artificial intelligence (AI) for early detection of breast cancer. The company’s clinical functions for screening clinics provide feedback on breast density, compression, dose, and quality, while its enterprise-wide practice software management helps with productivity, compliance, reimbursement and patient tracking.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: B-Secur, Claronav Kolahi, RapidAI, Precision Biomonitoring, Precision Spine.
Biosig Technologies Inc. and the Mayo Foundation for Medical Education and Research are jointly developing next-generation artificial intelligence (AI)-powered software for Biosig’s Pure EP electrocardiograph system. The Pure EP system acquires, measures, calculates and stores electrocardiographic and intracardiac signals for patients during electrophysiology procedures. The collaboration aims to expand the captured signals and combine them with other data sources to provide more actionable information.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clew, Pulse Biosciences.
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