Vivasure Medical announced in October the successful enrollment of the first patient in the Frontier IV clinical study, a non-randomized multicenter international trial, designed to expand the indications of the PerQseal large arteriotomy closure technology. The patient was enrolled by Peter Crean, M.D., at the Blackrock Clinic, Dublin, Ireland.

Corindus Vascular Robotics Inc. announced recently that Houston Methodist DeBakey Heart & Vascular Center has launched the first vascular robotic program in the Houston area with the installation of two Corindus CorPath GRX Systems. In addition and as part of the program launch, Corindus will partner with Houston Methodist to develop a Global Center of Excellence that will seek to advance clinical research on robotics and to train interventional cardiologists on robotic-assisted percutaneous coronary interventions (PCI).

HeartFlow Inc. announced that Health Care Service Corp. (HCSC), which operates Blue Cross and Blue Shield plans in five states, has issued a medical policy for the HeartFlow FFRct Analysis, a non-invasive technology that helps clinicians diagnose and treat patients with suspected coronary artery disease (CAD). HCSC — which operates Blue Cross Blue Shield plans in Illinois, Montana, New Mexico, Oklahoma and Texas — has determined that the use of noninvasive fractional flow reserve (FFR) following a positive coronary computed tomography (CT) angiogram may be considered medically necessary to guide decisions about the use of invasive coronary angiography in patients with stable chest pain at intermediate risk of CAD.

December 22, 2017 — To help streamline treatment of patients with heart failure and ensure the best possible patient ...

December 21, 2017 — Bay Labs, a medical technology company applying artificial intelligence (AI) to cardiovascular ...

Philips recently announced agreements with 3D Systems and Stratasys, two global leaders in the 3-D printing industry, to help progress patient care and improve the clinician experience. Advanced 3-D modeling provides radiologists with additional views to help strengthen anatomical knowledge which could enhance clinical impact in reviewing complex, multi-disciplinary cases.

ERT recently announced it has acquired iCardiac Technologies, a provider of centralized cardiac safety and respiratory solutions that accelerate clinical research. Financial terms of the transaction were not disclosed.

The U.S. Food and Drug Administration (FDA) recently issued a final guidance, “FDA Categorization of Investigational Device Exemption Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions”, which modifies the FDA’s policy on categorization of IDE devices used in clinical studies. Devices with an approved Investigational Device Exemption (IDE) are categorized into one of two categories by the FDA — Experimental (Category A) devices or Nonexperimental/Investigational (Category B) devices — based on the level of risk the device poses to the patient. This categorization is used by CMS to determine whether an IDE device, and certain services related to those devices, may be covered by CMS.