FDA Clears First Blood Test for Concussion Detection
The FDA granted marketing clearance to Banyan Biomarkers’ Brain Trauma Indicator — the first blood test for evaluating concussions.
The review and authorization, completed in less than six months, was expedited under the Breakthrough Devices Program in collaboration with the U.S. Defense Department.
The device measures neurologically released levels of proteins and provides test results in no more than four hours, allowing clinicians to determine whether to perform a CT scan.
The FDA said the test has the potential to rule out the need for a CT scan in at least one-third patients suspected of having mild traumatic brain injuries.
DreaMed Diabetes Gets CE Mark for Diabetes Management Platform
Israel-based devicemaker DreaMed Diabetes obtained a CE Mark for its Advisor Pro decision-support platform for management of Type 1 diabetes.
The cloud-based decision software uses the company’s proprietary machine learning algorithms to analyze data collected from insulin pumps, continuous glucose monitors, among other connected medical devices, as well as food consumption data.
The analyses can be used to identify personalized insulin doses.
FDA Clears Quidel Influenza A+B Assay
San Diego-based developer of diagnostic testing solutions Quidel received FDA clearance for its QuickVue Influenza A+B assay.
The assay allows for the rapid, qualitative detection of influenza type A and type B antigens directly in nasal swab and nasopharyngeal swab specimens, the company said.
It is designed to identify and differentiate between the two influenza viruses in about 10 minutes.
Arterys Wins FDA Clearance for Oncology Imaging Software
Arterys received 510(k) marketing clearance for the Arterys Oncology AI suite of software, covering all solid tumors.
The software automates the segmentation of lung nodules and liver lesions, with accuracy equal to segmentations performed manually. The initial focus will be for liver MRI and CT scans as well as for lung CT scans, the company said.
The cloud based system enables clinicians to get provide second opinions from within the hospital or from outside experts.
Abiomed Snags New Indication for Impella Heart Pumps
Abiomed received expanded FDA premarket approval for a new indication on its Impella 2.5 and Impella CP heart pumps.
The pumps are the only percutaneous temporary ventricular support devices FDA-approved for high-risk percutaneous coronary interventions, including stenting and balloon angioplasties, the company said.
Edwards Lifesciences Earns CE Mark for CENTERA Valve
Edwards Lifesciences received a CE Mark for its self-expanding CENTERA valve for severe, symptomatic aortic stenosis patients at high risk of open-heart surgery.
The valve is repositionable and retrievable and can be delivered through a motorized delivery system.
The CE Mark was based on the trial results from a study of 203 high-risk patients at 23 centers in Europe, Australia and New Zealand.
Paragonix Technologies Receives CE Mark for Two Cardiac Transport Devices
Paragonix Technologies earned a CE Mark for its SherpaPak and SherpaPerfusion cardiac transport systems.
The SherpaPak is a single-use, disposable device for the hypothermic static preservation and transport of donor hearts. The SherpaPerfusion system is a single-use, disposable device for hypothermic oxygenated perfusion preservation and transport of donor hearts.
Following the commercial launch of SherpaPak in the United States, the company plans to introduce the devices to transplant centers across Europe.
FDA Clears Foot and Ankle Plating System
Centric Medical received 510(k) marketing clearance for its Centric foot and ankle plating system for use in stabilization and fixation of fractures or osteotomies, intra and extra articular fractures, joint depression, and multifragmentary fractures.
Centric Medical is a division of Life Spine focused on developing surgical implants for the treatment of distal extremity pathology.
FDA Grants Humanitarian Use Designation for Nativis System
The FDA granted the Nativis Voyager Pediatric system a Humanitarian Use Designation.
The device uses a proprietary ultra-low radio frequency energy (ulRFE) technology designed to treat medulloblastoma, a rare, high-grade glioma in children.
Corindus Receives FDA Clearance for CorPath GRX System
Corindus Vascular Robotics, a developer of precision vascular robotics, received 510(k) marketing clearance for use of its CorPath GRX System in peripheral vascular interventions.
The CorPath GRX system broadens the capabilities of the CorPath robotic technology platform from exclusively treating coronary artery disease to include peripheral artery disease. The system allows the cardiologist to sit at a radiation-shielded workstation to advance guide catheters, stents, and guidewires with millimeter-by-millimeter precision.