FDA Approves AI Technology to Diagnose Wrist Fractures
The FDA signed off on the marketing of an artificial intelligence program for easier detection of wrist fractures.
Imagen’s OsteoDetect uses an AI algorithm to analyze wrist X-rays in a variety of environments. “It is an adjunct tool and is not intended to replace a clinician’s review of the radiograph or his or her clinical judgment,” the FDA said in announcing its approval.
Imagen submitted two retrospective studies that the company claimed showed the technology could help practitioners better identify fractures.
The FDA reviewed OsteoDetect through the De Novo premarket review pathway for low-to-moderate-risk devices.
Mauna Kea Receives FDA Clearance for Cellvizio
Mauna Kea Technologies won 510(K) clearance from the FDA for its Cellvizio laser endomicroscopy platform, 100 series F400 and F800 with a new Confocal Miniprobe, the CranioFlex, for use during neurosurgical procedures.
The Cellvizio 100 with the CranioFlex provides imaging of tissue internal microstructures and allows the identification of cells and vessels and their organization within the central nervous system during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection.
The Cellvizio 100 series F400 model operates at 488 nm and the F800 model at 800 nm, two wavelengths commonly used during brain surgery for imaging and navigation.
The device enables neurosurgeons to perform real-time optical biopsies to help determine if a tumor is completely excised.
DxTerity Diagnostics’ Radiation Blood Test Earns CE Mark
DxTerity Diagnostics received CE Mark certification for its REDI-Dx radiation biodosimetry test used to measure an absorbed ionizing radiation dose after a nuclear event.
The blood test gives individualized estimates of absorbed radiation from a peripheral blood sample and measures a patient’s biological response to radiation.
Physicians can use the blood test’s estimates in conjunction with clinical symptoms and radiation dispersal monitoring to prioritize patients for medical treatment.
Lumendi Receives FDA Clearance for DiLumen Scissors
Lumendi received 510(k) clearance for its DiLumen Is endolumenal interventional scissors, a single-use electrosurgical device for cutting, dissecting and cauterizing tissue within the digestive tract during endoscopic procedures.
The DiLumen platform consists of a single-use, soft flexible sheath that fits over standard and small-diameter endoscopes. The device uses two balloons to create a stable therapeutic zone.
The scissors are part of a platform designed to improve endoscopic interventions for colonic lesions, such as the common condition polyps.
TELA Bio Earns CE Mark for Reinforced Bioscaffolds
Surgical reconstruction company TELA Bio received a CE Mark for its OviTex reinforced bioscaffolds for use in soft tissue repair and announced plans for a European launch.
The company first commercialized the product in the U.S. for ventral hernia repairs and abdominal wall reconstruction procedures.
The reinforced bioscaffolds are surgical implants that blend biologic and synthetic materials and allow movement of fluid and cells as well as functional tissue remodeling.
MicroVention’s Stents Win FDA Pre-Market Approval
The FDA granted pre-market approval for MicroVention’s neurovascular stents used to treat aneurysms.
Previously approved under a humanitarian device exemption, the stents feature low-profiles and consistent visibility for use in patients suffering from wide-neck aneurysms.
The devices are used to stabilize the blood vessels around the opening to a wide-neck aneurysm while a coil is deployed within the aneurysm.
K2M Gets FDA Clearance for Surgical Planner
K2M announced that its Balance ACS surgical planner device received clearance from the FDA for preoperatively measuring and recording a patient’s skeletal parameters.
The system is used to balance the spine using a 360-degree approach in the axial, coronal and sagittal planes for addressing each anatomical vertebral segment.
The surgical planner allows surgeons to collect baseline measurements used in the creation of patient-specific rods, which can be used with Mesa, Everest and Denali spinal systems.
Branchpoint Technologies Receives Clearance for Intracranial Pressure Monitor
The FDA granted 510(k) clearance for Branchpoint’s Aura Intracranial Pressure (ICP) Monitoring System, enabling mobile ICP monitoring in patients with brain injuries.
The Aura system is wireless both in power and in its transmission of patient data, enabling telemetric monitoring of pressure.