MemoryMD Gets FDA Clearance for Wireless EEG Amplifier
MemoryMD received FDA clearance for its NeuroEEG, a wireless amplifier that transmits EEG signals to computers and cloud-based databases via Bluetooth. The device is used to monitor concussions and traumatic brain injuries.
A separate component called NeuroCap, a disposable EEG cap, is still awaiting clearance. The combination of NeuroEEG and NeuroCap can enable neurologists to cut the time for EEG appointments by 20 minutes, the company said.
Alfa Scientific Wins 510(k) Clearance for Fecal Blood Test
Alfa Scientific Designs received 510(k) clearance for its iFOB with Driven Flow immunoassay for identifying human blood in feces, a possible symptom of pre-cancerous polyps and colorectal cancer.
The test requires just one drop of sample solution wand can provide a result in one minute, about five times faster than standard lateral flow assays.
Colorectal cancer is the third most common cancer diagnosed in the U.S. and the second leading cause of cancer death despite a high cure rate. Early diagnosis yields a 90 percent cure rate.
Stryker’s Tritanium TL Lumbar Cage Gains 510(k) Clearance
Stryker received 510(k) clearance for its Tritanium TL curved posterior lumbar cage, an interbody fusion cage intended for lumbar fixation.
The device is a hollow implant that uses a material designed for bone ingrowth and biological fixation and complements Stryker’s Titanium PL cage. It is shaped for steerability and is designed so the cage can be rotated.
The Tritanium TL is indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
Stryker said the product will be available in the second quarter of 2018.
Sky Medical Receives 510(k) Clearance for Edema Reduction
Sky Medical Technology received 510(k) clearance to market its geko device for edema reduction in clinical applications.
The disposable battery powered device is the size of a wristwatch and delivers neuromuscular electrostimulation, increasing blood flow equal to 60% of walking without the user having to move or exert energy.
U.K.-based Sky Medical is the developer of the OnPulse neuromuscular electrostimulation platform.
Quidel Receives 510(k) Clearance for Lyme Assay
Quidel received 510(k) clearance for its Sofia Lyme fluorescent immunoassay to aid in diagnosis of Lyme disease.
The assay detects antibodies to Borrelia burgdorferi in serum and plasma specimens from patients suspected of B. burgdorferi infection.
The assay works with Quidel’s Sofia and Sofia 2 systems. It also comes connected to Quidel’s Virena data management system, which provides aggregated, de-identified testing data in near real-time.
Synergy’s BioSphere Putty Secures Regulatory Clearance in Australia
Synergy Biomedical received clearance from Australia’s Therapeutic Goods Administration for its bioactive bone graft product BioSphere Putty.
The product uses spherical bioactive glass particles to create a moldable bone graft putty that improves bone formation.
The product previously received FDA and CE Mark clearances and has been marketed since 2013.
Myoscience Receives 510(k) Clearance for Nerve Stim Enabled Smart Tip
Myoscience received FDA 510(k) clearance for its Smart Tip with Nerve Stim. The hand-held device uses disposable tips to deliver focused cold to targeted nerves.
The device enables physicians to access nerves in the shoulder, hip, and knees to apply cold therapy and block pain signals from peripheral nerves.
FDA Clears BD Onclarity HPV Assay
The FDA cleared Becton Dickinson’s Onclarity human papillomavirus assay for marketing.
The assay detects DNA from 14 high risk human papillomavirus types that are associated with cervical cancer.
The automated laboratory test is used on BD’s Viper LT system. The test specifically identifies HPV types 16, 18 and 45 while concurrently detecting types 31, 33, 35, 39, 51, 52, 56, 58, 59, 66 and 68.
iCAD Granted CE Mark for Breast Cancer Detection Device
iCAD received a CE Mark for its PowerLook Tomo Detection 2.0, the company’s second deep-learning based computer aided detection device for breast cancer.
The PowerLook uses an algorithm that is trained to detect malignancies and determine the probability of cases having malignant findings. It provides radiologists a “certainty of finding” score for each detected lesion. The device is compatible with Hologic, GE and Siemens systems.
Alfa Scientific Wins 510(k) Clearance for Multi-Drug of Abuse Assay
Alfa Scientific Designs received 510(k) marketing clearance for its Simple Cup multi-drug of abuse urine immunoassay.
The test identifies thirteen drugs or drug metabolites and provides results in two minutes. The device maintains line integrity for at least two hours with 98.88% accuracy.
The assay is cleared for both professional and home use.
Cardiovascular Systems Wins Clearance for Coronary Balloon
Cardiovascular Systems received 510(k) clearance for the OrbusNeich 1.0 millimeter Sapphire II PRO coronary balloon.
CSI is the exclusive U.S. distributor of OrbusNeich balloon products.
It plans to launch OrbusNeich’s full balloon product portfolio in the U.S. in 2018 and 2019.