TransMedics (NSDQ:TMDX) announced last night that an FDA advisory panel issued a favorable vote supporting approval for its OCS Liver System. Yesterday, the Nasdaq market halted trading of TransMedics’ common stock as it awaited the outcome of a meeting of the FDA’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee, set to review […]
Pre-Market Approval (PMA)
Nasdaq halts trading of TransMedics stock with FDA set to review OCS Liver System
TransMedics (NSDQ:TMDX) announced today that the Nasdaq market halted trading of the company’s common stock. Andover, Mass.-based TransMedics, which develops organ transplant transportation platforms, saw its common stock close down -5.3% at $31.69 yesterday. The company awaits the outcome of today’s meeting of the FDA’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory […]
FDA grants PMA to Abiomed’s next-generation Impella RP
Abiomed (NSDQ:ABMD) announced today that the FDA granted premarket approval (PMA) to its Impella RP with SmartAssist. Danvers, Mass.–based Abiomed received PMA for the Impella RP right heart pump with SmartAssist as a safe and effective treatment for acute right heart failure for up to 14 days, according to a news release. The company touts […]
Axonics files FDA PMA supplement for its non-rechargeable SNM system
Axonics (NSDQ:AXNX) announced that it filed a premarket approval supplement with the FDA for its sacral neuromodulation (SNM) system. Irvine, Calif.-based Axonics filed the PMA supplement for its newly developed, long-lived, non-rechargeable SNM implantable neurostimulator (INS), according to a news release. The company designed its new non-rechargeable SNM system to replicate the key features of […]
TransMedics says FDA advisory committee will review its OCS Liver System in July
TransMedics (NSDQ:TMDX) announced that the FDA confirmed that it will review its premarket approval application next month. Andover, Mass.–based TransMedics said the FDA scheduled a public advisory committee meeting to review the PMA application for the OCS Liver System, an organ transplant transportation platform, for July 14, 2021. In the committee meeting, the FDA’s Gastroenterology […]
FDA approves Medtronic’s next-gen Pipeline Flex device with anti-clotting tech
Medtronic (NYSE:MDT) announced today that it received FDA approval for its Pipeline Flex embolization device with Shield Technology. Fridley, Minn.–based Medtronic’s Shield Technology is a proprietary platform designed to advance flow diversion therapy through a surface-modified implant device that demonstrates a reduction in material thrombogenicity — a reduction in the tendency of the surface treatment material […]
FDA grants IDE approval for Cerus Endovascular’s Contour Neurovascular System clinical study
Cerus Endovascular announced today that it received FDA investigational device exemption for a trial for its Contour Neurovascular System. Fremont, Calif.–based Cerus’ Contour Neurovascular System is designed to treat intracranial aneurysms. Its creators made it of fine mesh braid to target the neck of the aneurysm away from the vulnerable dome. It’s possible to self-anchor […]
FDA advisory committee positive about TransMedics’ OCS Heart system
TransMedics (NSDQ:TMDX) this week said that the FDA Circulatory Systems Device Advisory Panel voted in favor of the OCS Heart System. The FDA panel voted 12 to 5, with 1 abstaining, that the benefits of the OCS Heart System outweigh the risks. The panel also voted 10 to 6, with 2 abstaining that there is reasonable […]
FDA approves Medtronic’s Harmony transcatheter pulmonary valve system
FDA has approved a Medtronic device described as a first-in-the-world, non-surgical heart valve to treat severe pulmonary valve regurgitation — a condition often arising from congenital heart disease. The Harmony transcatheter pulmonary valve system could delay the time before someone with congenital heart disease might need additional open-heart surgery, FDA said today. The Harmony device […]
FDA permits marketing of first COVID-19 diagnostic test through premarket review process
The FDA announced that it granted marketing authorization to Biomérieux subsidiary BioFire Diagnostics for its SARS-CoV-2 (COVID-19) test. Although the test already had emergency use authorization (EUA), the new marketing authorization was granted through the de novo premarket review pathway, marking the first SARS-CoV-2 diagnostic permitted to be marketed beyond the public health emergency, according […]
Abbott launches real-time remote neuromodulation tech
Abbott (NYSE:ABT) announced today that the FDA has approved a neuromodulation treatment platform that allows physicians to communicate with patients and monitor or change their treatment in real-time. The NeuroSphere Virtual Clinic could increase access to treatment for patients with chronic pain or movement disorders who don’t live close to a care provider, have difficulty accessing […]
