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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
Six EU countries have turned up the heat on medical product sponsors who haven’t shared the findings of their clinical trials, with significant success, a new analysis finds. Read More
Pulnovo Medical reported positive results for its radiofrequency device for pulmonary arterial hypertension (PAH) in a presentation at the Transcatheter Cardiovascular Therapeutics annual scientific symposium in Boston, Mass. Read More
The Regeneten Biodinductive Implant from Britain’s Smith+Nephew delivered an 86 percent reduction in rotator cuff re-tear rates at 12 months, according to interim study results presented at a conference last week in Dublin. Read More
New research published in the NEJM Evidence shows potential for Nordic Bioscience’s PRO-C6 assay becoming a next-generation biomarker in trials studying patients with heart failure with preserved ejection fraction (HFpEF). Read More