Company Product Description Indication Status
Abbott Laboratories, of Abbott Park, Ill. Freestyle Libre Sensor-based glucose monitoring system Replaces blood glucose testing and detects trends and tracking patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments in adults with diabetes Presented data from the RELIEF, a retrospective study analyzing the impact of Freestyle Libre portfolio use on the incidence of hospitalizations for diabetic ketoacidosis (DKA); researchers assessed nationwide reimbursement claims data in France of 74,158 people living with diabetes, including 33,203 people with type 1 diabetes and 40,955 people with type 2 diabetes; overall, annual DKA rates dropped by 52% in those with type 1 diabetes and 47% in those with type 2 diabetes when using the Freestyle Libre system; the greatest reductions in DKA-related hospitalizations occurred in people who did not conduct traditional fingerstick testing, as well as those who performed fingersticks more than 5 times per day, regardless of previous test strip usage; in those who did not fingerstick, results showed decreases of 60% and 51% in people with type 1 and type 2 diabetes, respectively; for people who performed fingersticks more than 5 times per day, findings showed drops of 59% for people with type 1 diabetes and 52% for people with type 2 diabetes
Abbott Laboratories, of Abbott Park, Ill. Freestyle Libre Sensor-based glucose monitoring system Replaces blood glucose testing and detects trends and tracking patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments in adults with diabetes Presented study demonstrating a sustainable HbA1c decrease at 12 months for patients using the Freestyle Libre system; through a real-world analysis of the National Diabetes Register in Sweden, researchers identified 39,554 people with type 1 or 2 diabetes using the Freestyle Libre system; a subgroup of people who had used the Freestyle Libre system for 9-15 months were able to significantly lower their HbA1C levels with a sustained effect at 12 months (0.44% drop in people with type 1 diabetes and a 0.66% reduction in those with type 2 diabetes)
Abbott Laboratories, of Abbott Park, Ill. Freestyle Libre Sensor-based glucose monitoring system Replaces blood glucose testing and detects trends and tracking patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments in adults with diabetes Presented a retrospective, observational analysis of 1,244 people with type 2 diabetes on short-acting insulin in the U.S.; found use of the Freestyle Libre system was associated with substantial reductions of 51% in acute diabetes events and 28% in all-cause hospitalizations
Exact Sciences Corp., of Madison, Wis. Oncotype DX Genomic Prostate Score (GPS) Test Assay that analyzes 17 genes across four biological pathways from tumor tissue removed during biopsy to provide a GPS result with a score ranging from 0-100 Helps make treatment decisions for men with clinically low-risk or favorable intermediate-risk prostate cancer  Published results in Urology from study in patients with unfavorable intermediate (UFI)-risk prostate cancer; researchers conducted additional statistical analyses of GPS results from two previously published cohort studies in men treated with radical prostatectomy; the study included 299 intermediate-risk patients, 175 of whom were classified as UFI-risk; results showed that UFI-risk patients with a GPS test result >40 had outcomes consistent with high-risk disease and a poor prognosis, indicating they may benefit from more aggressive therapies; UFI-risk patients with a GPS value <40 had outcomes similar to favorable intermediate-risk patients, suggesting less aggressive therapy may be needed
Halo Diagnostics, of Menlo Park, Calif. Guided laser focal therapy Destroys prostate tissue under MRI guidance using laser energy Treatment for prostate cancer Released interim 10-year results from its phase II 20-year clinical trial for prostate laser focal therapy in patients with localized prostate cancer; more than 170 men, 45-years or older diagnosed with low-to-intermediate risk or recurrent prostate cancer participated in the study; demonstrated less than 1% infection, less than 1% erectile dysfunction and less than 1% incontinence vs. conventional whole gland prostatectomy, which has a risk of up to 50% erectile dysfunction and 25% urinary incontinence
Lucence Diagnostics Pte. Ltd., of Singapore Safer Sample saliva collection kit  Collection kit for saliva specimens that includes stabilization fluid to be mixed with the sample at the point of collection For the collection of SARS-CoV-2 samples Study demonstrated that the proprietary reagent provided with the Safer Sample kit achieved complete inactivation of SARS-CoV-2 virus within 45 seconds of exposure; the reagent also was able to stabilize viral RNA at room temperature for up to 1 week
Medtronic plc, of Dublin Abre Venous self-expanding stent system For use in the iliofemoral veins for treatment of symptomatic venous outflow obstruction Reported results from the ABRE clinical study assessing the safety and effectiveness of the investigational Abre system; the prospective, interventional, single-arm study included 200 subjects with symptomatic iliofemoral venous outflow obstruction from 24 sites throughout the U.S. and Europe; the primary effectiveness endpoint evaluated primary patency at 12 months, and the primary safety endpoint evaluated the incidence of composite major adverse events (MAE) within 30 days following stenting of an obstruction in the iliofemoral venous segment; the study met its primary safety endpoint with a 2.0% (4/200) rate of MAEs within 30 days; also met its 12-month primary effectiveness endpoint with an overall primary patency rate of 88.0% (162/184); the data demonstrated a freedom from clinically driven target lesion revascularization (TLR) rate of 92.4% (170/184) through 390 days
Sequana Medical NV, of Ghent, Belgium Alfapump Fully implanted wireless device that automatically pumps fluid from the abdomen into the bladder For the management of fluid overload in liver disease, malignant ascites and heart failure Results of MOSAIC, the North American feasibility study of the Alfapump in recurrent and refractory liver ascites were published in Liver Transplantation; the prospective, single-arm, multicenter study included 30 cirrhotic patients with recurrent or refractory ascites not eligible for transjugular intrahepatic portosystemic shunt; demonstrated that the Alfapump dramatically reduced the mean large-volume paracentesis frequency per patient per month from 2.4 (±1.4) to 0.2 (±0.4); implantation with the Alfapump also resulted in a clinically significant improvement in patients' quality of life and a better biochemical index of their nutritional status

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