Inovio has received the FDA go-ahead for a phase 3 trial of INO-4800, a DNA plasmid vaccine against COVID-19. 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

The FDA reminded in vitro diagnostic (IVD) makers that they must get Institutional Review Board (IRB) approval for clinical studies of IVDs that involve human subjects, including those using leftover, deidentified human specimens in FDA-regulated studies. Read More

The Apple Watch can detect irregular heartbeats beyond atrial fibrillation (AF) arrhythmias. Read More