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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
Despite pleas for approval during a public comment period, the FDA’s Psychopharmacologic Drugs Advisory Committee failed yesterday by a vote of 12-to-1 to recommend Levo Therapeutics’ intrasanal carbetocin — an oxytocin analogue delivered via a spray pump — for treatment of hyperphagia and related anxiety in children with a rare genetic disorder, Prader-Willi Syndrome. Read More
Device sponsors who want to supply real-world data to the FDA to support a product application need to consider how it can answer a specific regulatory question, advised Kristin Zielinski Duggan, partner at the law firm Hogan Lovells, in an FDAnews webinar. 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
Outset Medical has received the first-ever approval under new Medicare rules that allow the federal program to pay for innovations in dialysis. Read More
After mulling mountains of data on Endologix’s AFX2 endovascular graft, an expert panel of the FDA’s Medical Devices Advisory Committee came to an unofficial conclusion: The stent — which has had a troubling propensity to fail — may be a good option in some small niche populations, but it’s not suitable for use in broad populations. Read More
Sponsors of some types of device software should file “enhanced documentation” as part of premarket submissions, the FDA says in a draft guidance released yesterday. Read More