Keeping you up to date on recent developments in diagnostics, including: Improving diagnosis of brain diseases; Predicting survival of COVID-19 patients; New causal gene for chronic kidney disease.
Reports of multiple new variants of the SARS-CoV-2 virus have emerged, raising questions about the efficacy of vaccines, but also regarding the utility of diagnostic and other tests. The U.S. FDA’s Tim Stenzel said single-target tests are thus at a greater risk of returning a false negative result, adding that these developers “should consider this carefully” in surveillance of their tests.
What is the outlook for investment in digital health over the coming year? A group of investment experts tackled that question during a session of the Digital Medicine & Medtech Showcase, which is being held virtually this week. Although COVID-19 was disruptive, there was a huge increase in health innovation investment last year, with a jump of roughly 56%, said Logan Plaster, director and editor-in-chief at Startup Health.
Diagnostics innovator Renalytix AI plc and dialysis giant Davita Inc. partnered to develop a program to identify individuals with early-stage kidney disease and improve outcomes for the 37 million Americans with chronic kidney disease (CKD). The companies plan to launch the collaborative effort in three cities in 2021 to build a diverse, real-world evidence dataset as a base for moving forward.
Glaukos Corp. reported 12-month results from the pivotal IDE trial of its Istent Infinite trabecular micro-bypass system, showing substantial reduction in mean diurnal intraocular pressure (IOP) in patients with open-angle glaucoma uncontrolled by prior surgery or medication. The company is targeting U.S. FDA approval of the device for standalone moderate-to-severe glaucoma in late 2021.
PERTH, Australia – Australia’s Medical Technologies and Pharmaceuticals Industry Growth Center (MTPConnect) is boosting funding for the translation and commercialization of research in diabetes, cardiovascular disease and regenerative medicine.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: New test beats biopsy for transplant rejection; NICE eyes digital health HTAs; MHRA moves on the hazards of bedrails; TGA zeroes in on tests for COVID-19; HHS posts rule for agency enforcement action.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Excalibur Healthcare Services, Siemens Healthineers, Vestibular First.
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