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.