At long last, the FDA granted premarket approval to Senseonics Holdings Inc.’s fully implantable Eversense E3 continuous glucose monitoring (CGM), an implantable device that provides accurate glucose readings for six months. The CGM will be available in the U.S. through Senseonics’ commercial partner, Ascensia Diabetes Care Holdings AG, starting in the second quarter. In Europe, the previous generation Eversense XL is available today and the company plans to launch the E3 in the third quarter of 2022. Read More
Abbott Laboratories reported the commencement of a pivotal clinical trial for its Aveir pacemaker in a two-device configuration to provide dual-chamber pacing without the need for leads to deliver the charge. This configuration required the development of i2i technology to ensure that the two Aveirs communicated in a manner that ensures consistent pacing, but the 500-enrollee study has a long road ahead of it before the company can finalize the application with the FDA. Read More
Mica Biosystems Ltd. is linking up with U.K. innovation center Cell and Gene Therapy Catapult (CGT Catapult) to accelerate commercialization of its regenerative technology platform. CGT Catapult is supporting the Birmingham, U.K.-based startup as it engages in conversations with the U.K.’s Medicines and Healthcare Products Regulatory Agency for clinical trials testing its remote-controlled stem cell therapy platform. Read More
PARIS – Damae Medical SAS has just raised nearly $6 million to develop new technology to detect skin cancer noninvasively without need for a biopsy. This series A round was led by BNP Paribas Développement SA and supported by original investors Kurma Partners SA and professional private equity fund, Paris Saclay Seed Fund. Read More
Paragonix Technologies Inc. will soon release performance data from sterile, temperature-controlled systems for transporting donor organs to recipient patients, this after a breath-taking transport last year of a donor lung and heart from Alaska to Washington and North Carolina. Paragonix’s organ preservation technology provides thermal protection for donor organs for up to 40 hours, making them ideal for transportation over long distances, said the company. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Asieris, Depuy Synthes, J&J, Photocure. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Senseonics. Read More
