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. Read More
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. Read More
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. Read More
The latest report by the Medicare Payment Advisory Commission (MedPAC) includes an advisory about unfettered expansion of telehealth, but the commission also said that expanded access to ambulatory surgical centers could trim per-procedure spending, which in some instances is about half the fee paid for a given procedure when performed in a hospital outpatient department (HOPD). Read More
PERTH, Australia – The launch of Australia’s first medical device development and manufacturing facility in Melbourne is set to fast-track new treatments for people with conditions such as epilepsy, Parkinson’s disease, hearing loss, stroke and diabetes. Read More
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. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: One Drop. Read More
