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Sunday, May 28, 2023

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FDA Continues Co-sponsorship of MedCon Conference with AFDO/RAPS Healthcare Products Collaborative

FDA will continue its long-standing co-sponsorship of the MedCon Conference. With a focus on fostering open discussions of the most pressing issues facing the medical device industry, the AFDO/RAPS Healthcare Products Collaborative recently announced that their new partnership will carry on Xavier Heath’s 12-year legacy of delivering the MedCon Conference.

The MedCon 2022 Conference will be held virtually May 4 – 6, 2022. The event will bring together medical device regulators and industry experts from around the world for content-rich conference sessions that include uncommon collaboration, deep dialogue, and networking as close as your computer.

“The annual MedCon conference helps fulfill the Department of Health and Human Services’ and FDA’s important mission to protect public health,” says Gina Brackett, Director, Compliance Branch at FDA ORA Office of Medical Device and Radiological Health. “MedCon has historically provided outreach and engagement with our colleagues in the medical products industry to discuss trends, innovations, and challenges in an educational setting. We are pleased that this new partnership between AFDO and RAPS intends to continue that focus. We feel it is important to be key facilitator of the discussion.”

FDA has made education of the device manufacturing community a high priority to help ensure the quality of FDA-regulated medical products.

MedCon 2022 registration is now open. For more information and to view the virtual program details, visit www.healthcareproducts.org/MedCon. Information about the Collaborative and announcements for future events can be found at www.healthcareproducts.org.

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Data at Heart Rhythm 2023 Highlight Key Boston Scientific Therapies

Boston Scientiic reports the results from the global, prospective, non-randomized, single-arm FROZEN-AF IDE study of the POLARx Cryoablation System met the safety and effectiveness endpoints of the trial. The study, which examined use of the device for the treatment of patients with paroxysmal, or intermittent atrial fibrillation (AF), included an extension arm for the POLARx FIT Cryoballoon Catheter, a single device capable of enabling 28 and 31mm sizes. The extension arm sub-study also achieved its safety and effectiveness endpoints and included 50 patients who were treated with at least one application of the 31mm cryoballoon and will be followed for 12 months. At the time of data release, patients had undergone six out of a total of 12 months of follow up.

First Multi-Center Study Combining the Allurion Program With GLP-1 Therapy Presented at the European Congress on Obesity

The retrospective study was conducted across 3 obesity centers in Italy, Spain and Egypt. In total, 181 patients with BMIs of 27 and above were enrolled in the Allurion Program with Saxenda® (liraglutide) added once daily starting 4 to 16 weeks after balloon placement. On average, the duration of drug treatment was just over 4 months (4.1 ± 2.2 months).

EuroPCR 2023: Late-Breaking Clinical Data Demonstrate Elixir Medical’s DynamX Bioadaptor Restores Vessel Motion and Function with Better Effectiveness at 12 Months Compared to a Leading Drug-Eluting Stent (DES)

DynamX Bioadaptor is a new type of coronary implant designed to unlock the scaffold, uncage the vessel, to return normal vessel motion and function after percutaneous coronary intervention (PCI), with continued dynamic support of the atherosclerotic vessel to reduce long-term adverse events. In the study, the bioadaptor demonstrated superior effectiveness of its unique mechanism of action across secondary intravascular imaging endpoints, achieving restoration of the vessel motion and function compared to persistent constraint with DES.

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