If finalized the proposal would replace the current CMS coverage policy under which patients at high risk for carotid endarterectomy (CEA) with asymptomatic carotid artery stenosis of greater than 80% can be covered only when carotid artery stenting procedures are performed in an FDA Category B
Investigational Device Exemption trial, an FDA-approved postapproval study, or in accordance with Medicare clinical trial policy.
Currently, silicone gel-filled breast implants may be available to certain women only through a clinical study conducted under the
Investigational Device Exemptions (IDE) regulations or an FDA-approved adjunct study.
(KOOL) has submitted an
Investigational Device Exemption (IDE) Supplement to the FDA) for a previously approved clinical trial testing the safety and effectiveness of the point-of-care SurgWerks system in the treatment of late stage, "no-option" and "poor-option" critical limb ischemia (CLI) patients.
In early July, Edwards announced it had received a conditional
investigational Device Exemption (DE) from the FDA to initiate the TRANSFORM Trial, a prospective, multi-year study that will evaluate the company's Intuity valve system.
Food and Drug Administration (FDA)
Investigational Device Exemption (IDE) clinical study, and the system commercially has been released outside of the United States.
(BULLETIN BOARD: CPCF), Sarasota, Fla., reports that its subsidiary, Med Enclosure, LLC, has submitted an
Investigational Device Exemption ("IDE") application to the U.S.
Prior to the decision to allow Medicare coverage of carotid stent placement, the Food and Drug Administration had approved the procedure under its
Investigational Device Exemption Program.
Titan Medical announces that the human factors evaluation required to support its planned
Investigational Device Exemption, or IDE, filing with the FDA was completed successfully and received a highly favorable assessment from the surgeon investigators.
Episurf Medical AB (STO: EPIS B), a provider of minimally invasive and personalised treatment alternatives for people with painful joint injuries, announced on Monday the receipt of approval from the US Food and Drug Administration (FDA) for its
Investigational Device Exemption (IDE) application to initiate a clinical study on the Episealer knee implant.
CardiAQ has received a US Food and Drug Administration
Investigational Device Exemption approval to conduct an early feasibility study of up to 20 patients, and also plans to initiate a CE Mark study in Europe.
The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and is being studied in an
Investigational Device Exemption (IDE) pilot study for the treatment of patients with complete (AIS A) traumatic acute spinal cord injury.