Senseonics Eyes Longer-Term CGM Sensor

Senseonics had all the right ingredients to pull in strong earnings in 2019. The continuous glucose monitoring (CGM) specialist had a strong product on the market and significant reimbursements – yet the company fell short of expectations. Now Senseonics is coming into 2020 with all guns firing. The Germantown, MD-based company is making headway in developing a longer-term CGM sensor. FDA gave Senseonics the greenlight to have a subgroup of the PROMISE study participants to continue for a total of one year to gather feasibility data on the safety and accuracy of the 365-day Eversense sensor. In a release, Mukul Jain, PhD, COO at Senseonics said, “Extending this study is really a critical step in developing a 365-day product. Information gathered from this cohort will allow us to characterize the improved sensor design and optimize our glucose algorithm for the extended, 365-day use period. This addition is an exciting extension phase of the PROMISE study and we look forward to evaluating the first multi-clinic investigation of a one-year implantable glucose sensor.” The overall goal of the PROMISE Clinical Study is to evaluate the safety and efficacy of the Eversense CGM System in people with diabetes over 180 days for the PMA submission to FDA. One hundred and eighty-one study participants at eight sites across the U.S. had the Eversense CGM System inserted subcutaneously as part of the study, which is completing the 180-...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news

Related Links:

Second Sight Medical Products is the latest medtech company to face tough losses as a result of the financial impact of the novel coronavirus (SARS-CoV-2). The Sylmar, CA-based company is laying off 84 of its 108 employees and said it intends to wind-down operations. The firm develops implantable visual prosthetics that are intended to create an artificial form of useful vision for blind individuals. FDA greenlit the Argus II retinal prosthesis system in 2013. Plans now call for the Second Sight to retain an adviser experienced in winding down operations to guide the board on the next steps. Any wind down activity, if impl...
Source: MDDI - Category: Medical Devices Authors: Tags: Implants Business Source Type: news
Most transgender adults seeking gender-affirming surgery (GAS) experienced gender dysphoria by age 7, a cross-sectional study at Cedars-Sinai Medical Center in Los Angeles suggests.Reuters Health Information
Source: Medscape Medical News Headlines - Category: Consumer Health News Tags: Diabetes & Endocrinology News Source Type: news
Publication date: Available online 31 March 2020Source: Diabetes &Metabolic Syndrome: Clinical Research &ReviewsAuthor(s): Andrea Da Porto, Viviana Casarsa, Gianluca Colussi, Cristiana Catena, Alessandro Cavarape, Leonardo Sechi
Source: Diabetes and Metabolic Syndrome: Clinical Research and Reviews - Category: Endocrinology Source Type: research
Publication date: April 2020Source: Canadian Journal of Diabetes, Volume 44, Issue 3Author(s): Ilia Ostrovski, Leif E. Lovblom, Daniel Scarr, Alanna Weisman, Nancy Cardinez, Andrej Orszag, C. Marcelo Falappa, Émilie D'Aoust, Ahmad Haidar, Rémi Rabasa-Lhoret, Laurent Legault, Bruce A. Perkins
Source: Canadian Journal of Diabetes - Category: Endocrinology Source Type: research
Publication date: April 2020Source: Canadian Journal of Diabetes, Volume 44, Issue 3Author(s):
Source: Canadian Journal of Diabetes - Category: Endocrinology Source Type: research
Publication date: April 2020Source: Canadian Journal of Diabetes, Volume 44, Issue 3Author(s): Elizabeth Sellers
Source: Canadian Journal of Diabetes - Category: Endocrinology Source Type: research
Publication date: April 2020Source: Canadian Journal of Diabetes, Volume 44, Issue 3Author(s):
Source: Canadian Journal of Diabetes - Category: Endocrinology Source Type: research
Publication date: April 2020Source: Canadian Journal of Diabetes, Volume 44, Issue 3Author(s):
Source: Canadian Journal of Diabetes - Category: Endocrinology Source Type: research
Publication date: April 2020Source: Canadian Journal of Diabetes, Volume 44, Issue 3Author(s):
Source: Canadian Journal of Diabetes - Category: Endocrinology Source Type: research
AbstractInsulin was discovered by Banting and Best in 1921, and was subsequently applied for the treatment of diabetes. Porcine or bovine insulin purified from their pancreas had been used clinically for more than 50 years until the development of the methods to produce recombinant human insulin by genetical engineering techniques. The Diabetes Control and Complications Trial (DCCT) (1) and our Kumamoto Study (2) provided the evidences that better glycemic control could be obtained by intensive insulin therapy consisted of the supplementation of both basal and postprandial insulin, which in turn resulted in the prevention ...
Source: Journal of Diabetes Investigation - Category: Endocrinology Authors: Tags: UPDATES Source Type: research
More News: Conferences | Diabetes | Endocrinology | Eyes | Medical Devices | Study | Tetracycline