Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Casio, Cloudcath, Tytocare.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Datar Cancer Genetics, Motus GI, Sequana Medical.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Senseonics.
The FDA’s November 2021 draft guidance for contents of premarket submission for device software functions may have been a desperately needed update for a legacy 2005 guidance, but stakeholders see one glaring omission from the draft. Both the Advanced Medical Technology Association and Pharmaceutical Research and Manufacturers of America pointed to the absence of sign-off by the FDA’s Center for Drug Evaluation and Research (CDER) for the draft, a conspicuous omission because a combination product with software may include a drug regulated by CDER.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Center for Pain & Stress Research, Esaote North America.
The FDA has issued a safety notification regarding the tubes used in enteral feeding sets, which can lead to inadvertent strangulation of infants and toddlers. The agency said it has received two reports of deaths of toddlers due to strangulation in 2021, but at this time is only recommending that caregivers exercise special caution in ensuring that tubes not be left where strangulation is a possibility.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Check-Cap, Sirtex.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Atheart Medical, Carestream, Cerevasc.
The FDA’s device center reported the addition of four device types to the ranks of class II devices, including one each for de novo petitions by Apple Inc., of Cupertino, Calif., and Roche Molecular Systems Inc., of Pleasanton, Calif.