Approvals

InBios Cleared for Dengue Detection Kit

The FDA granted 510(k) clearance to InBios’ DENV Detect NS1 Elisa Kit, used for detection of the dengue virus in patients.

The antigen detection assay is used for presumptive clinical laboratory diagnosis of the Dengue virus and has not been cleared for testing blood or plasma donors.

The kit uses samples collected from patients within the first week of showing symptoms of dengue fever or dengue hemorrhagic fever to detect the presence of the dengue virus.

Micro Ultrasound Device Gains Further Canadian Approval

Exact Imaging’s FusionVu application, a feature of its ExactVu micro-ultrasound system, received regulatory approval from Health Canada.

The ExactVu micro-ultrasound platform provides real-time high resolution for targeted prostate biopsies.

The newly approved feature can be used to assist in analysis of a patient’s MRI by aligning it with the live micro-ultrasound image.

OptraScan’s Whole-Slide Scanners Receive CE Mark

OptraScan’s on-demand desktop scanning devices have been approved for marketing in the EU.

The small-sized devices, which are used to scan slides and come in 20x and 40x magnification, fit in small workspaces and have cloud capabilities, as well as low and high throughput and a small footprint.

The slide scanners, which come in four different models, allow flexible storage, archiving and management of the metadata and digital images produced from scanning, as well as different features depending on the model.

Xact Robotics Earns CE Mark for Robotic Navigation System

Xact Robotics gained CE Mark approval for its robotic navigation and steering system used for image-guided percutaneous procedures.

The system has been cleared for use in planning and accessing areas in the abdomen during percutaneous procedures that are led by X-rays or ultrasound.

After the physician selects a target and entry point using the system, the robotic navigation system suggests a trajectory, along with verification checkpoints along the recommended path.

Motus GI Cleared to Market Slim Sleeve for Colonoscopes

The FDA granted 510(k) clearance for Motus GI to market its Pure-Vu Slim Sleeve for use with slim colonoscopes.

The company’s Pure-Vu Slim Sleeve device performs cleansing the same way as the standard Pure-Vu Sleeve device, and both are compatible with the Pure-Vu workstation.

The sleeve fits over the colonoscope during a colonoscopy, allowing physician to safely clean matter during the procedure and gain clear visualization of the colon mucosa.

Illuminoss Receives Additional Clearance for Bone Stabilization System

The system can be used to create an implant that conforms to the patient, providing strength and stability across the implant supporting the weakened bone.

The FDA has granted Illuminoss additional clearance for its photodynamic bone stabilization system.

The device can now be used by skeletally mature patients to treat traumatic, fragility, pathological and impending pathological fractures of the humerus, radius and ulna.

FDA Approves Device for Treatment of Acute Coronary Artery Perforations

The FDA approved Biotronik’s PK Papyrus Covered Coronary Stent System for treating acute coronary artery perforations or tears in the blood vessels of the heart — the first device approved by the agency for the indication in 17 years.

The device is advanced into the perforated coronary artery vessel using a balloon catheter. Once the stent is implanted, it provides a physical barrier to seal the tear in the artery wall while still allowing blood to flow through the device to the heart muscle.

The agency granted the approval through its humanitarian device exemption pathway. It reviewed real-world survey data from 80 patients who received stents.

Philips Gains CE Mark for Beltless Maternal Monitoring Device

Philips received CE Mark approval for its Avalon system, a fetal and maternal monitoring device that updates a patient’s electronic medical record.

The beltless device is based on electrode technology and is used to stream patient data, such as fetal and maternal heart rate and uterine activity, to the electronic record via Philips’ obstetrical information management system.

The device features a single patch and reusable pod that are placed on the mother’s belly to capture critical parameters.

Contego Cleared for Carotid PTA Balloon System

The FDA granted 510(k) clearance for Contego’s Paladin Carotid percutaneous transluminal angioplasty (PTA) balloon device for removing embolic material.

The device, which is used in carotid stent procedures, pairs an angioplasty balloon with an integrated 40-micron filter, giving it enhanced procedural flexibility and an extra level of protection.

Its embolic protection filter can be adjusted in vivo to account for differing patient anatomies.