Early feasibility studies for cardiology devices were a massive problem for the FDA and industry in times gone by, a problem that was believed to drive device flight from the U.S. That problem has been largely solved, according to the FDA’s Andrew Farb, but Farb noted that neurological devices are the next target for improved early feasibility study (EFS) development in the U.S., which suggests that the path to pivotal studies for devices in this space will soon be much less cumbersome.
Myra Vision Inc. has raised $17 million in series A financing and intends to use the funds to advance product development, scale infrastructure and expand its team in support of the glaucoma treatment device’s development. Its name was changed from Myra Medical Inc. along with the financing.
Medtronic plc is ceasing global sales and distribution of its Heartware ventricular assist device (HVAD) due to safety concerns. The news sent Medtronic shares down about 1% in early morning trading. The Dublin-based company said it made the decision to stop selling the HVAD left ventricular assist device after clinical comparisons found a higher frequency of neurological adverse events, including stroke and mortality, with its heart pump device vs. other circulatory support systems.
A first-of-its-kind blood test that can detect whether cancer is absent, imminent, or present in different stages is on its way to the market. This is a claim made by brothers Ashish Tripathi and Anish Tripathi, who lead Singapore-based molecular diagnostic company Tzar Labs Pte. Ltd. and Mumbai-based Epigeneres Biotechnology Pvt. Ltd., respectively.
Data on the prevalence of diabetes in the U.S. show that non-Hispanic white people are least likely to suffer from the disease. Yet to date most genetic studies of the glycemic traits that are used to diagnose and monitor type 2 diabetes and cardiometabolic health have focused on individuals of European ancestry.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avicenna.Ai, Ihealthscreen, Medtronic.
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