While saying "white rabbit, white rabbit" on the first of the month may be a luck-bringing superstition, Whiterabbit.ai aims to take luck out of the equation in identifying early breast malignancies. The Santa Clara, Calif.-based company emerged from stealth mode with FDA clearance for its Wrdensity tool, two other products, and more than $49 million in funding to date.
Information Data Systems Inc., doing business as One Drop, has earned the CE mark for its blood glucose prediction analysis engine to accurately forecast glucose levels up to eight hours in advance. The artificial intelligence (AI)-powered tool is indicated for people living with prediabetes, type 2 diabetes, including those on oral medications and/or insulin regimens, and gestational diabetes.
TORONTO – Ambu Inc. has won Health Canada clearance for a flexible, single-use cystoscope for diagnosing, managing, and treating lower urinary disorders such as incontinence and bladder cancer. The disposable Ascope 4 Cysto system goes head-to-head with reusable urology scopes that must be reprocessed after each use, diminishing image quality and mechanical performance, said Jens Kemp, Ambu’s vice president of marketing for North America.
For almost two months, Brazil’s health care surveillance agency Anvisa, the European Medicines Agency (EMA), and the Directorate-General for Health and Food Safety have been sharing regulatory and confidential information as part of an effort to improve the safety and efficacy of drugs and medical devices.
Additive manufacturing, often referred to as 3D printing, has evolved considerably over the past few decades, and plays a significant role in the world of orthopedic devices. Despite numerous technological advances, additive manufacturing (AM) still accounts for a small share of the device market and may never overwhelm traditional manufacturing for the med-tech industry due to a number of limitations.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acutus Medical, Becton Dickinson, Crannmed, Labcorp, Zoll Medical.
It’s no secret that physicians are the interface between device makers and the patient, but their role in cybersecurity has been limited to date. However, Christian Dameff, assistant professor of biomedical informatics and computer science at the University of California San Diego, said its time to engage physicians once they are in practice and to include cybersecurity in medical school education, two efforts he said would go a long way toward improving medical device cybersecurity in the clinical setting.