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. Read More
Synchron Inc. landed $40 million in new funding through a series B fundraising round led by Khosla Ventures. This round brings the total amount raised by the company to $59 million since its founding in 2016. Other participants in the round included Forepont Capital Partners, ID8 Investments, Shanda Group, General Advance, Subversive Capital, and Re.mind Capital as well as Arani Bose and Thomas Reardon. Returning investors included Neurotechnology Investors, Metis Innovative, and the University of Melbourne. Read More
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. Read More
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. Read More
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. Read More
Two weeks ago, it was a grilling by the House Oversight Committee over the pricing of blockbuster drugs Humira and Imbruvica and a request for the FTC to launch an investigation into Abbvie Inc.’s patent settlements that delayed Humira biosimilar competition in the U.S. until 2023. This week, Abbvie became the face of a new investigation by the Senate Finance Committee over how multinational companies are shifting profits overseas as a way to avoid U.S. taxes. Read More
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. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avicenna.Ai, Ihealthscreen, Medtronic. Read More
