Approvals
Molecular Matrix Snags FDA Clearance for Bone Graft Technology
Molecular Matric received FDA 510(k) clearance for its Osteo-P musculoskeletal technology for bone regeneration.
The musculoskeletal solution is intended for filling bone defects caused by surgical procedures or traumatic injuries. The bone graft substitute is made with a hyper-crosslinked carbohydrate polymer.
Topcon Medical Systems Wins FDA Nod for Imaging Device
Ophthalmic instrumentation developer Topcon Medical Systems received 510(k) marketing clearance for its DRI OCT Triton Series.
The imaging device features a built-in retinal camera for tracking eye movement while capturing selected scans.
LivaNova Line of Arterial Cannulae Suite Scores CE Mark
London-based devicemaker giant LivaNova received CE Marking for its line of PureFlex adult arterial cannulae.
The portfolio offers a variety of curved and straight tip cannulae options to meet clinical needs.
The products feature a wire-reinforcement spring to deliver flexibility without kinking.
Siemens Healthineers Wins FDA Clearance for Blood Analysis Assays
The FDA cleared two point-of-care blood analysis tests manufactured by Siemens Healthineers.
The company’s Blood Urea Nitrogen test and its Total Carbon Dioxide test are intended to aid clinicians in diagnosing renal diseases and metabolic imbalances.
The tests can be performed on Siemens’ handheld epoc Blood Analysis System at the patient’s side to enable faster clinical decisionmaking.
Asuragen Expands CE Mark on Cancer Monitoring Assays
Molecular diagnostic product developer Asuragen expanded its CE Mark on two chronic myeloid leukemia monitoring assays for use on the Roche Diagnostics cobas z-480 analyzer.
The QuantideX qPCR BCR-ABL IS Kit and the QuantideX qPCR BCR-ABL minor Kit can detect and quantify major or minor fusion transcripts, with automated reporting of results.
They are intended to provide improved sensitivity for clinical assessments of patients’ response to tyrosine kinase inhibitor therapies.
FDA Clears Ultrasound Diagnostic Systems From French Device Firm
SuperSonic Imagine, a France-based medical device company, received FDA 510(k) clearance for its Aixplorer and Aixplorer Ultimate ultrasound diagnostic systems.
The clearance is for noninvasive clinical assessments of hepatic fibrosis and steatosis.
The Aixplorer systems provide imaging and measures of liver and spleen stiffness in real-time.
FDA Clears Teleflex Peripheral Snare Devices
The FDA cleared Teleflex’s new versions of its Expire Elite and Sympro Elite snares.
The snares are used to retrieve or reposition intravascular foreign objects, such as balloons, coils or catheters.
Both products come preassembled in a one-piece design that allows rapid deployment through any 0.035” compatible lumen, the company said.
Amiko Medication Sensors Snag CE Mark for Use With Three Inhalers
Amiko Digital Health, a London-based developer of digital health tools powered by artificial intelligence, received a CE Mark for its Respiro medication sensors for use with inhalers from three different pharmaceutical companies.
The new certificate allows for the devices to be integrated in the EU into Teva’s Spiromax inhaler, Chiesi’s Nexthaler inhaler, and GlaxoSmithKline’s Ellipta inhaler.