Surmodics recently announced it received 510(k) clearance from the Food and Drug Administration for its Pounce LP (Low Profile) Thrombectomy system.
The new product will help clinicians treat acute limb ischemia, which is associated with 30-day amputation and mortality rates as high as 30% and 11.5%, respectively.
Introduced in 2021, the Pounce Thrombectomy system is intended for the nonsurgical removal of thrombi and emboli from the peripheral arterial vasculature in vessels 3.5–6 mm in diameter. The addition of the low-profile (LP) model will allow for more efficient clot removal in below-the-knee peripheral arteries 2–4 mm in diameter, Surmodics said.
Surmodics officials said that catheter-directed thrombolysis in vessels below the knee is limited against organized clot and requires ICU admission, while small-diameter aspiration thrombectomy devices may struggle to remove organized material in the distal lower extremity. Expansion of the Pounce platform’s treatment range allows the company to address tibial clots, an important component of treatment in a vulnerable patient population.
FDA CLEARS CYTOVALE’S INTELLISEP SEPSIS TEST
Cytovale’s IntelliSep test has received 510(k) clearance from the Food and Drug Administration (FDA).
According to Cytovale, IntelliSep is the first FDA-cleared test to assess cellular host response to aid in the diagnosis of sepsis in emergency department patients and contribute to rapid life-saving decisions. The test provides results in under 10 minutes from a standard blood draw.
IntelliSep categorizes patients into three bands according to their probability of sepsis. The test, which runs on the Cytovale system, assesses immune response using immune cell morphology.
By applying pressure to thousands of cells and observing their reaction, IntelliSep can show distinct changes in white blood cells from septic patients. These changes are captured in images and then characterized using a proprietary algorithm.
Test results may help providers optimize clinical outcomes and empower hospitals to improve resource utilization. IntelliSep also may support hospital efforts to meet guidelines set by the Centers for Medicare & Medicaid Services for timely sepsis treatment, known as SEP-1, according to the company.
HOLOGIC SARS-COV-2/FLU A/B/RSV ASSAY RECEIVES CLEARANCE
Hologic recently announced 510(k) clearance from the Food and Drug Administration for its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay.
The test detects and differentiates four of the most prevalent respiratory viruses: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A (flu A), influenza B (flu B), and respiratory syncytial virus (RSV). The assay runs on the fully automated, high-throughput Panther Fusion system, which provides initial results in approximately 3 hours and can process more than 1,000 tests in 24 hours.
The system, along with Hologic’s respiratory virus menu, offers various testing options from a single sample and allows healthcare professionals and laboratories to personalize patient testing based on medical history and local prevalence, according to Hologic.
The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay launches with the new RespDirect collection kit, which enables laboratories to directly load samples for processing on the Panther Fusion system without any uncapping or specimen transfer steps, potentially saving time and reducing errors, repetitive stress injuries, and exposure to viruses.
BD GETS CLEARANCE FOR AI SOFTWARE FOR MRSA DIAGNOSTICS
BD recently announced 510(k) clearance from the Food and Drug Administration for its new BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) imaging application.
The BD Kiestra MRSA application uses artificial intelligence (AI) to interpret bacterial growth, release negative specimens with minimal human interaction, and automate the traditionally labor- and time-intensive task of inspecting petri dishes to determine bacterial growth.
As a result, laboratory personnel can spend more time on higher-value analysis.
The application can evaluate single specimens or group together the large volume of plates with non-significant growth for batch review and release of negative results, possibly reducing the burden on technicians.
The MRSA imaging application uses AI algorithms to look for specific culture characteristics on the BBL CHROMagar MRSA II plate. Based on that information and analysis by BD Synapsys informatics, plate images are automatically organized and sorted into worklists for laboratory scientists and technicians.
Company officials said their products help labs deal with ongoing labor challenges by allowing labs to use their limited staff more efficiently.
ROCHE CSF ALZHEIMER’S DISEASE ASSAYS GET FDA CLEARANCE
Roche has announced that its Elecsys beta-Amyloid (1-42) cerebral spinal fluid (CSF) II (Abeta42) and Elecsys Total-Tau CSF assays (tTau) have received 510(k) clearance from the Food and Drug Administration (FDA).
The Elecsys CSF Abeta42 and tTau assays—used as a tTau/Abeta42 ratio—measure two biomarkers of Alzheimer's disease (AD) pathology, beta-amyloid and tau proteins, in adults aged 55 and older being evaluated for the disease.
The FDA-cleared Elecsys tTau/Abeta42 ratio supports timely AD diagnosis and treatment decision-making and expands Roche’s AD CSF portfolio to include biomarkers for all three main pathological processes of Alzheimer's—amyloid plaques, tau tangles, and neurodegeneration.
Scalable Elecsys AD CSF assays can be added to any of Roche’s cobas fully automated immunoassay analyzers, giving patients broad access to testing in a timely manner.
Currently, AD diagnoses are largely made by ruling out non-Alzheimer’s causes based on a number of evaluations, including various cognitive exams, routine laboratory tests, and neuroimaging with MRI or CT scans of the head. Additional evaluations with biomarkers specific to AD can identify underlying pathological changes early in the disease, Roche said.
The appropriate use recommendations for new and emerging Alzheimer’s medicines call for confirmation of amyloid pathology via CSF tests and PET scan imaging, the company noted.