Years after a setback to its clinical program, Medtronic plc‘s Symplicity brand renal denervation (RDN) system appears to be firing on all pistons. The Dublin-based company said this week that it will begin enrolling patients in a pilot study to assess the safety and efficacy of its newer-generation Symplicity Spyral using a targeted procedural approach with fewer radiofrequency (RF) ablations.
As the deadly coronavirus continues to spread, countries around the world are scrambling to understand the public health threat and identify and quarantine people who may be infected. To that end, Novacyt SA has launched a molecular test that detects only the 2019 strain of the coronavirus, reducing the chance of false diagnoses.
Medtronic plc has gained CE mark approval for its Cobalt and Crome portfolio, the company’s first implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy-defibrillators (CRT-Ds) to offer connected health via Bluesync technology. The portfolio will be rolled out on a country-by-country basis throughout Europe, with initial implants in select countries to begin soon.
Abbott Laboratories has received CE mark approval for its Tendyne transcatheter mitral valve implantation (TMVI) system, the first such device approved for use in Europe and the world. The system is intended for patients with leaky mitral valves that are beyond repair and those at high risk for open heart surgery.
IDbyDNA Inc., a San Francisco-based metagenomics technology company, scooped up $20 million in series B financing in a round led by Artis Ventures. Genesys Capital and others participated in the round. The company plans to use the money to accelerate uptake of its Explify software platform.
IDbyDNA Inc., a San Francisco-based metagenomics technology company, scooped up $20 million in series B financing in a round led by Artis Ventures. Genesys Capital and others participated in the round. The company plans to use the money to accelerate uptake of its Explify software platform.
GI Dynamics Inc.’s U.S. IDE trial of Endobarrier, which is designed for patients diagnosed with type 2 diabetes and obesity, is now underway with the first patient enrollment at Michigan Medicine in Ann Arbor, Mich. The FDA approved the pivotal STEP-1 clinical trial in August 2019 to evaluate the Endobarrier as a barrier between the small intestine and food to reduce calorie intake.
Liquid biopsy startup Elypta AB has raised €6.1 million (US$6.72 million) in a late seed financing led by Industrifonden and Sciety. Norrsken Foundation’s newly launched €100 million “impact-first” fund also contributed to the round. The Stockholm-based company plans to use the money to complete development of laboratory kits and software for measurement and analysis of a panel of metabolites it has identified.
Abbott Laboratories had a winning week, scoring U.S. FDA approval of its Infinity directional deep brain stimulation (DBS) system in treating symptoms of Parkinson’s disease not adequately managed by medication. The company also reported new data underscoring the benefits of its Proclaim XR neuromodulation system in people living with chronic pain.