We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Brooklyn, N.Y.-based FesariusTherapeutics’ DermiSphere dermal scaffold supported a skin graft from full-thickness skin loss more effectively and more quickly in a preclinical study than existing dermal templates, the company’s researchers reported in the peer-reviewed Journal of Tissue Engineering and Regenerative Medicine. Read More
DNA sequencing giant Illumina is teaming up with AstraZeneca to seek out potential new drug targets using Illumina’s genomic analysis artificial intelligence (AI) technology. Read More
OrthoGroup was handed a Form 483 after an inspection of its Rancho Cordova, Calif., facility found incomplete device history records (DHR), missing corrective and preventive action (CAPA) records and multiple procedures not being followed. Read More
Merck KGaA has partnered with French devicemaker Biocorp to create a new version of Biocorp’s Mallya pen injector smart device for delivery of human growth hormone. Read More
Medtronic’s extravascular (EV) implantable cardioverter–defibrillator (ICD) had a 98.7 percent successful defibrillation rate after implantation in a recent study, researchers reported in the New England Journal of Medicine. Read More
Natera’s Signatera circulating tumor DNA (ctDNA) test outperformed the cancer antigen CA 125 test by one month and radiological imaging by 10 months in identifying patients with the highest risk of recurrence of epithelial ovarian cancer (EOC), researchers reported in the journal Gynecologic Oncology. Read More
Most machine learning-enabled medical devices are cleared by the FDA without efficacy demonstrated in a randomized clinical trial, researchers at the Harvard-MIT Health Sciences and Technology program reported in the journal JAMA Network Open. Read More
A first-in-human feasibility trial of SpyGlass Pharma’s combination product to treat glaucoma led to a 45 percent drop in patients’ mean intraocular pressure at three months without the need for additional therapy, the company said at the American Academy of Ophthalmology annual meeting in Chicago. Read More
Eyenuk’s EyeArt artificial intelligence (AI) system had a sensitivity of 96.4 percent in identifying more than mild diabetic retinopathy (mtmDR) while dilation eye exams had a 27.7 percent sensitivity in the identical study group, researchers reported at the American Academy of Ophthalmology's annual meeting in Chicago. Read More
Patients using Beta Bionics’ iLet Bionic Pancreas had an average lower blood glucose level and 11 percent more time in the target blood sugar range, according to study results published in the New England Journal of Medicine (NEJM).Read More