December’s new medical device approvals include the FDA approval of Abbott Laboratories’ CentriMag circulatory support system for postcardiotomy patients, MicroVention’s FRED system for wide-necked intracranial aneurysms and an expanded indication for Foundation Medicine’s FoundationOne CDx cancer-drug companion diagnostic.
The US Food and Drug Administration approved two original premarket approvals (PMA) and one panel-track PMA supplement in December 2019.
On 6 December, the agency approved a PMA for Abbott Laboratories Inc.’s CentriMag circulatory support system for patients...
The US FDA has cleared NeuroOne's OneRF trigeminal nerve ablation system for the treatment of trigeminal neuralgia. This minimally invasive method utilizes radio frequency energy to alleviate pain, offering an alternative to traditional medications and surgeries. A fall commercial launch is planned.
After receiving FDA clearance for its Genio sleep apnea implant, Nyxoah plans a major US rollout despite a patent suit from rival Inspire Medical. Genio offers bilateral nerve stimulation as a CPAP alternative, with strong trial results.
The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.
Medicare beneficiaries with tricuspid regurgitation will now have access to an innovative treatment from Abbott that offers a minimally invasive alternative to open-heart surgery.
The US FDA has cleared NeuroOne's OneRF trigeminal nerve ablation system for the treatment of trigeminal neuralgia. This minimally invasive method utilizes radio frequency energy to alleviate pain, offering an alternative to traditional medications and surgeries. A fall commercial launch is planned.
The US FDA posted three warning letters in July, covering medical supply kits, wearables and orthopedics.
After receiving FDA clearance for its Genio sleep apnea implant, Nyxoah plans a major US rollout despite a patent suit from rival Inspire Medical. Genio offers bilateral nerve stimulation as a CPAP alternative, with strong trial results.
