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Rapid antigen COVID-19 testing in adults doesn’t identify as many early infections as reverse-transcriptase polymerase chain-reaction (RT-PCR), but in children, accuracy was quite high, two new studies have found. Read More
The first biopolymer heart valve, developed by Foldax USA, has passed initial human trials and is ready for deployment into a larger study population, the company said. Read More
Immunicom presented preliminary data from a clinical trial investigating a potential therapy for resistant melanoma and other solid cancers using an external blood-filtering device, showing that the treatment is safe and well-tolerated. Read More
Several major manufacturers of tests for the SARS-CoV-2 virus that causes COVID-19 are saying their products will detect infections caused by the new Omicron variant first identified in South Africa and now spreading rapidly around the world. Read More
Patients with treatment-resistant high blood pressure who were treated with ReCor Medical’s Paradise ultrasound renal denervation system — which uses radiofrequency ablation to burn the nerves in the renal arteries — maintained lower blood pressure over six months in a clinical trial, the company said. Read More
AbbVie’s investigational subcutaneous ABBV-951( foslevodopa/foscarbidopa) delivery system racked up impressive numbers in a pivotal 12-week phase 3 study for patients with advanced Parkinson’s disease. Read More
ViaCyte’s implantable pouch filled with stem-cell-derived pancreatic cells is advancing in a first-in-human type 1 diabetes trial, showing clinically meaningful improvements in glycemic control and blood sugar, accompanied by a 70 percent decrease from the peak insulin dose. Read More
The FDA usually follows the advice of its advisory committees, but what that will mean in the case of Integra LifeSciences' SurgiMend for breast reconstruction is anybody’s guess, because the agency’s General and Plastic Surgery Devices Panel was deeply divided on the device’s safety and efficacy when it met last week. Read More
Vertex Pharmaceuticals will submit an Investigational New Device (IND) application next year for a drug/device combination that delivers insulin-producing, lab-created islet cells in a membrane packet to protect them from the body’s immune system. Read More