Leadless cardiac electrophysiology devices have been around for a while now, but Abbott Laboratories of Abbott Park, Ill., has managed to beat the competition to 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.

Lumos gains FDA nod on third try for Febridx 510(k) as stock rockets 327%

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. The inappropriate and unnecessary prescribing of antibiotics is recognized as a significant contributing factor to the growing global emergence of antimicrobial resistant strains of bacterial pathogens. Initially, a de novo application was submitted to the FDA in October 2020 for Febridx, and it was converted into a traditional 510(k) in November 2020. It went through a review and was put on administrative hold until March 2021, and then was reactivated. The company completed the DISRUPT clinical trial, and the FDA allowed the company to curtail the trial and use the data to support the 510(k). Lumos saw its stock plummet 65% in July 2022 when the FDA first rejected its Febridx 510(k) because it was not substantially equivalent to the predicate device.

Sinotau nets $152M in financing to develop radiopharmaceuticals in China

Sinotau Pharmaceutical Group raised ¥1.1 billion (US$152 million) in a financing round to develop its radiopharmaceutical drugs for diagnostic and therapeutical interventions. Founded in 2005, Beijing-based Sinotau has developed a product pipeline with more than 10 radiopharmaceuticals candidates for cardiovascular disease, Alzheimer's disease and cancer, based on self-development and collaborations. The company expects that its radioactive tracer Neuraceq (florbetaben F18) will be approved for marketing in China by the end of 2023, becoming the first Amyloid-β positron emission tomography imaging agent in the country.

Sequana reports promising results for its automatic pump to control ascites

Sequana Medical NV 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 have recently been presented at the European Association for the Study of the Liver 2023 congress in Vienna, Austria. The POSEIDON study enrolled a cohort of 71 patients with refractory or recurrent ascites from nearly 20 sites across the U.S. and Canada. “The results show that the Alfapump virtually eliminated the need for extensive paracentesis, and significantly improved patient quality of life six months following implantation,” Florence Wong, hepatologist at Toronto General Hospital, and principal investigator for the POSEIDON study, told BioWorld.

Retinal imaging sees the future of CKD

Photographs of the retina combined with an artificial intelligence algorithm accurately predicted chronic kidney disease (CKD) prior to symptom onset in a study published in Digital Medicine. The system, developed by Mediwhale Inc. and Yonsei University College of Medicine, examines the microvasculature of the retina, which shares characteristics with vessels in the kidneys, showed a superior ability to assess the risk of CKD compared to conventional estimated glomerular filtration rate tests of the blood or urine.

UK’s NICE says AI-assisted detection of lung nodules not ready for prime time

The U.K. National Institute for Health and Care Excellence released several draft and final health technology assessments on July 5, including a review of the use of artificial intelligence to aid in the detection of lung nodules. The agency said that more research is needed before it will be able to provide an unqualified endorsement because of a relative lack of data that could be reliably generalized from clinical study subjects to the broader U.K. population at large.

Hemodiafiltration technology significantly reduces mortality rate in kidney failure patients

The mortality rate of patients with kidney failure can be significantly reduced if they are treated with high-dose hemodiafiltration compared with the more commonly used high-flux hemodialysis, according to a study recently published in the New England Journal of Medicine. The results from the CONVINCE trial pave the way for the increased adoption of hemodiafiltration as a therapeutic option to treat patients with end-stage kidney disease.

Holiday notice

BioWorld's offices were closed in observance of Independence Day in the U.S. No issue was published Tuesday, July 4.

Also in the news

Abbott, Affidea, Biocardia, Biocomposites, Dexcom, Guardant Health, Liberate Medical, Microba Life Sciences, Oncoinvent, Pentax Medical, Renovos Biologics, Sonic Healthcare, Ventureblick