Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Breegi Scientific, Lifesignals, Mindpeak, Tasso.
The FDA’s legal authority to regulate lab-developed tests (LDTs) has come into question on several occasions in a number of venues, and the issue is enjoying new life yet again thanks to more activity on Capitol Hill. While two competing pieces of legislation are back in play, the most critical question may be whether the FDA has any authority left at all after the August 2020 rescission letter from the Department of Health and Human Services.
PERTH, Australia – Six classes of medical devices listed on Australia’s Register of Therapeutic Goods (ARTG) will fall under new classification requirements on Nov. 25, 2021, following numerous consultations with industry. The consultations were part of the Australian government’s plans to overhaul its medical device regulations to be more in line with the European Medical Device Regulation (MDR).
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axonics, Corvent Medical, Ice Neurosystems, Nexstim, Wise.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Defender Safety.
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.