FDA Clears Acuvue’s Oasys Contact Lenses
The FDA granted clearance for Acuvue’s Oasys contact lenses, indicated for daily use to correct vision impairments caused by myopia and hyperopia in patients with non-diseased eyes.
The contacts contain a photochromic additive that adjusts visible light filtered to the patient’s eye based on the amount of UV light they are exposed to, slightly darkening the lenses in bright sunlight and reverting to a regular tint in normal or darker light.
The lenses can also be used by individuals with certain degrees of astigmatism.
Ortho Connect V2.0 Wins Marketing Clearance
The FDA issued 510(k) marketing clearance for Ortho Clinical Diagnostics’ Ortho Connect V2.0, a middleware system that centralizes laboratory operations and workflow across networks and hospitals.
Ortho Connect allows blood banks and their data to be managed through a central terminal, and enables Ortho Vision immunohematology analyzers to connect with a hospital’s laboratory information systems through a single connection.
The middleware allows laboratories to exchange and manage data and complete regulatory process tasks that are difficult to perform alone, and enables them to centralize lab operations across the network.
FDA Clears Haemonetics’ NexSys PCS Enhancement
Haemonetics’ enhancement of its plasma collection tool, NexSys PCS, earned FDA marketing clearance.
The tool will offer the NexSys PCS device along with the NexLynk DMS donor management software and disposables.
The clearance allows the product to increase the plasma yield per collection.
Haemonetics plans a commercial launch of the tool this summer.
Auris’ Monarch Platform Receives 510(k) Clearance
The FDA approved Auris’ Monarch system, a flexible endoscope that can be used to diagnose lung cancer.
The device is cleared by the FDA for diagnostic and therapeutic bronchoscopic procedures. It uses computer navigation based on 3D models of the patient’s lung anatomy, allowing the user to access hard-to-reach parts of the lung.
SpinTech’s SPIN-SWI Software Approved by FDA
The FDA issued a go-ahead for SpinTech’s SPIN-SWI software for quantification and detection of neurovascular biomarkers in magnetic resonance images.
The software applies proprietary post-processing techniques to enhance the visualization of small blood vessels in the brain to assess clinical data provided by MR scanners.
The technology can process and evaluate images for conditions such as Parkinson’s disease, stroke, traumatic brain injury and vascular dementia.
CurveBeam’s Orthopedic Extremity CT Systems Earn CE Mark
CurveBeam received a CE Mark for its LineUP and InReach orthopedic extremity CT systems.
The systems, which can be plugged into standard wall outlets and have minimal shielding requirements, give radiology and orthopedic specialists three-dimensional bone detail of the orthopedic extremities.
The LineUP system allows the patient to stand during the scan so that anatomy can be assessed in the “weight bearing” position. It can perform full-leg bilateral scans, and an adaptive chair scans the hand, wrist and elbow.
Cardiva Medical’s Vascular Closure System Finds Further Approval
The FDA approved an expanded indication for Cardiva Medical’s Vascade vascular closure system, allowing it to be used for 5-7F femoral venous closures after being previously approved for arterial closures.
The system is intended for patients undergoing interventional cardiac catheterization procedures.
The device consists of a collagen patch and proprietary collapsible disk that achieve hemostasis while minimizing complications.
Sonoma’s Post-Laser Skin Therapy Gel Cleared by FDA
Sonoma Pharmaceutical’s antimicrobial gel received 510(k) clearance from the FDA to treat the skin of post-nonablative laser therapy and post-microdermabrasion therapy patients, in addition to treating post-superficial chemical peels.
The product is intended for dermatologists and aesthetic clinicians to manage medical procedures and post-procedure itch and pain associated with procedures like laser skin resurfacing.
The gel promotes advanced healing and protection against secondary infections that could occur after treatment.