Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Affidea, Biocardia, Guardant, Microba Life Sciences, Sonic Healthcare.
A non-invasive retinal exam may soon enable clinicians to visualize the future for patients at risk of chronic kidney disease (CKD). When combined with an artificial intelligence algorithm, an exam accurately predicted CKD prior to symptom onset in a study published in Digital Medicine.
Sequana Medical NV has reported additional data on safety, survival and quality of life from its POSEIDON pivotal study in North America, evaluating its Alfapump device used in the treatment of patients with recurrent or refractory ascites caused by liver cirrhosis. The data were recently presented at the European Association for the Study of the Liver 2023 congress in Vienna.
Rapid point-of-care diagnostics company Lumos Diagnostics Inc. saw its stock shoot up 327% on the news that it finally gained U.S. FDA 510(k) clearance for its Febridx rapid, point-of-care test for bacterial infections. Febridx is a finger prick blood test that can indicate if a person has a bacterial or viral acute respiratory infection within 10 minutes.
Leadless cardiac electrophysiology devices have been around for a while now, but Abbott Laboratories of Abbott Park, Ill., has managed to beat the competition in the market for dual chamber pacing via two leadless devices. The company reported July 5 that the U.S. FDA has approved the Aveir DR, a two-unit device configuration that provides pacing for both the right ventricle and the right atrium and which some analysts believe helps to make Abbott shares an underappreciated asset for investors.
The difficulties in rolling out the EU’s Medical Device Regulation are well known, but the attendant delays continue to exert ripple effects in other markets. The U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) has formally extended the time frame for acceptance of existing CE marked devices into the U.K. market, another demonstration of the ongoing turmoil associated with the herky-jerky deployment of the MDR.