Senseonics now can promote its Eversense continuous glucose monitoring system as a replacement for fingerstick testing to help patients make diabetes treatment decisions during the day, following FDA approval of a new non-adjunctive indication.
Senseonics Holdings Inc. will soon begin marketing its Eversense continuous glucose monitoring (CGM) system in the US as an alternative to fingerstick testing to help patients make diabetes treatment decisions throughout the day.
On 6 June, the US Food and Drug Administration approved a PMA supplement for new “non-adjunctive” labeling stating that Eversense...
Clairity’s "first-in-class" mammography-based AI screening tool, Clairity Breast, provides "equitable risk assessments," expanding access to lifesaving early detection for breast cancer, said company founder Connie Lehman.
Abbott received the US FDA nod for its Tendyne system, offering a minimally invasive alternative to replace the valves of patients with severe mitral valve disease who are at risk for open-heart surgery.
The US FDA has approved the Teal Wand, the first at-home cervical cancer screening device. Capable of detecting preclinical cancer with 96% accuracy, it will launch in California in June and expand nationwide soon after.
NeuroOne is preparing to submit its OneRF Trigeminal Nerve Ablation System to the US FDA for treating trigeminal neuralgia, a chronic facial pain condition. CEO Dave Rosa told Medtech Insight that he expects a possible product launch by fall 2025.
