FDA Panel Backs ReCor’s Renal Denervation System for Hypertension
The Paradise ultrasound renal denervation system got backing from the FDA’s Circulatory System Devices Panel as a possible treatment for hypertension, as manufacturer ReCor continues to hope for regulatory approval. On Tuesday, FDA advisors voted 10-2 that the benefits of the Paradise catheter-based system outweigh its risks when used to reduce blood pressure (BP) in […]
FDA Grants De Novo Request for Neuromodulatory System for Urge Incontinence
The FDA has granted a de novo marketing request for the Revi System for tibial neuromodulation to treat urinary incontinence with or without urinary urgency, BlueWind Medical announced on Thursday. The de novo request allows for treatment of men and women with urge urinary incontinence (UUI). Clinicians should follow applicable clinical guidelines and use professional […]
Favorable Long-Term Results With Ranibizumab Implant for Neovascular AMD
The ranibizumab port delivery system (PDS; Susvimo) with 6-month refill maintained noninferiority to monthly intravitreal injections for neovascular age-related macular degeneration (nAMD) out to 2 years, according to updated results from a randomized trial. Three assessments of best corrected visual acuity (BCVA) during years 1 to 2 showed differences ranging from -0.2 to +0.4 ETDRS […]
MACRA Gets Mixed Reviews at House Hearing
WASHINGTON — The physician payment system instituted under the Medicare Access and CHIP Reauthorization Act (MACRA) has brought some positive results but still needs to be improved, witnesses said Thursday at a House of Representatives hearing. “Despite the good intentions of policymakers, MACRA has not solved the issues with how Medicare pays doctors,” Joe Albanese, […]
More Transparency Needed in Healthcare, House Members Told
The U.S. healthcare system would be greatly improved by more transparency from all players, including hospitals, pharmacy benefit managers (PBMs), and insurers, members of Congress and witnesses agreed Wednesday at a House hearing. “For too long medical prices have been shrouded in mystery and patients have lived in fear of how much their medical bills […]
Ocular Capillary Ischemia Offers Early Warning of Diabetic Eye Disease Progression
An AI-driven automated optical coherence tomography angiography (OCTA) review system predicted progression of diabetic macular ischemia (DMI) with greater than 90% accuracy, a retrospective cohort study showed. DMI of the superficial capillary plexus at baseline more than doubled the risk of progression of diabetic retinopathy (DR), and DMI of the deep capillary plexus more than […]
Healthcare Mergers Need More Regulation and Oversight, Senators Told
Congress must act to rein in consolidation in the healthcare system while still encouraging competition, Shawn Martin of the American Academy of Family Physicians (AAFP) said Thursday during a Senate hearing. “A competitive healthcare marketplace benefits patients,” Martin, executive vice president and CEO of the AAFP, in Leawood, Kansas, said at a Senate Finance Committee […]
Novel Chemo Delivery System Achieves High Response Rate in Bladder Cancer
CHICAGO — An investigational intravesical delivery system designed to provide sustained local release of gemcitabine into the bladder produced high rates of complete response (CR) in difficult-to-treat non-muscle-invasive bladder cancer (NMIBC), data from an ongoing phase IIb study showed. Preliminary results from the SunRISe-1 trial demonstrated that monotherapy with the novel treatment, dubbed TAR-200, led […]
Test Predicts Transition From Normal to Impaired Cognition
The Stages of Objective Memory Impairment (SOMI) system predicted transitions from normal cognition to incident symptomatic cognitive impairment, longitudinal data showed. Over a mean follow-up of about 6 years, cognitively normal older adults with memory tests scores reflecting moderate retrieval impairment (SOMI-2) were twice as likely to progress to incident cognitive impairment as those whose […]
Cluster Headache, Migraine Linked to Circadian System
Cluster headache and migraine were linked to the circadian system, data from a meta-analysis and other research showed. Across 16 studies, cluster headache had a prominent circadian pattern of attacks in 70.5% of 4,953 participants, with a clear peak between 21:00 and 03:00 and circannual peaks in the spring and autumn, reported Mark Joseph Burish, […]