Approvals
Acandis Gains CE Mark for Accero Stent
German devicemaker Acandis has received a CE Mark for its Accero stent, a smooth-surfaced implant for treating intracranial aneurysms that is now available for sale in Europe.
Accero is a self-expanding braided stent that is designed to exhibit reliable coil retention. It can be delivered through double lumen balloon guide catheters and 0.0165 to 0.0170” microcatheters.
The stent’s titanium oxide/oxynitride protective film is designed with high oxygen and nitrogen intensities to improve vessel healing.
FDA OK’s Philips’ IntelliVue Mobile App
The FDA granted 510(k) clearance for Philips’ Intellivue GuardianSoftware mobile application, which allows clinicians to see a patients’ vital signs and early warning signs through a mobile device.
The app provides clinicians with real-time data so that they can receive warning of patient deterioration before adverse events occur.
The mobile app is designed to be compatible with certain wearable devices, such as biosensors.
QT Ultrasound’s QTviewer Gets FDA’s Green Light
The FDA has given QT Ultrasound 510(k) clearance for its QTviewer, the latest addition to its QT Ultrasound breast scanner.
The viewer stores images of the breast for viewing on a radiologist workstation, and has tools for additional image analysis, such as correlate, probe and region of interest.
The QTviewer generates coronal, axial and sagittal images that are used for review of the breast.
FDA Clears Microsoft’s HoloLens for Pre-Operative Surgical Planning
The FDA has granted 510(k) clearance for Microsoft’s HoloLens, allowing it to be used with the OpenSight Augmented Reality System for planning surgeries.
The OpenSight AR system overlaps 2D, 3D and 4D images on patient’s bodies to visualize what doctors may see internally during surgery.
A head-mounted smart glasses device, HoloLens is a self-contained holographic computer.
Baxter’s Renal Replacement System and Blood Warmer Cleared in EU
Baxter’s PrisMax renal replacement system and TherMax blood warmer both received the CE Mark allowing them to be marketed in the European Union.
The devices are cleared to be used in conjunction with one another. The PrisMax system is used for removing waste products, excessive fluids and inflammatory mediators, while the TherMax device maintains blood temperature while it is purified outside the body.
The two devices also assist in the management of sepsis and kidney injury.
Bio-Rad’s Blood Typing Device Receives FDA Clearance
The blood typing results are automatically transferred to Bio-Rad’s IH-Com patient data management software.
The FDA has granted 510(k) approval to Bio-Rad’s blood typing instrument, which is meant to be used in small to medium-sized laboratories.
The IH-Reader 24 device combines a reader with a centrifuge to read blood type and antibody screening results.
RPS Diagnostics Gains Updated CE Mark for RPC Test
RPS Diagnostics’ FebriDx, a rapid point-of-care test, has received an updated CE Mark, clearing it for launch in the EU.
The diagnostic test allows for a 10-minute assessment of the patient’s immune response to an acute respiratory infection by analyzing a fingerstick blood sample.
The single-use device points out underlying, clinically significant infections in patients and determines if they are bacterial or viral.
Concepta’s MyLotus Brand Receives CE Mark
Concepta’s MyLotus products, used to self-measure hormone levels, received the CE Mark.
The devices can be used at home to test a woman’s fertility levels to identify optimal fertility and increase the chance of pregnancy.
The products, which are expected to launch in the UK in the coming months via a new online platform, can be used as a low-cost alternative or prior to in vitro fertilization.