FDA GRANTS 510(K) CLEARANCE TO PHILIPS’ SMARTCT 3D IMAGING SOFTWARE
07 april | imaging
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Philips’ SmartCT image acquisition, visualisation and measurement software.
A crucial part of the Philips Azurion Image Guided Therapy System, SmartCT will offer interventionalists CT-like 3D images (Cone Beam CT), which will aid in the diagnosis, therapy planning, treatment and follow-ups for interventional radiology procedures.
SmartCT can improve clinical confidence, streamline workflows and boost productivity by bringing the intuitive touchscreen controls of advanced 3D image acquisition, visualisation, vessel/organ segmentation and quantitative measurements inside the sterile zone of the interventional lab and to the table-side.
Furthermore, with software applications for angiography, neurology, soft-tissue imaging and guidewire/catheter navigation, SmartCT can support various procedures, including treatment of aneurysms, vascular diseases and liver tumours.
Philips image guided therapy systems general manager Ronald Tabaksblat said: “A key part of our image-guided therapy strategy is to combine high-quality, low X-ray dose imaging with a superior user experience that allows interventional radiologists to diagnose and treat patients as part of smoother, safer and less interrupted workflows.
“Philips SmartCT is a major step forward in 3D imaging, enhancing confidence in the interventional suite and supporting key elements of the quadruple aim of better patient outcomes, enhanced patient and staff experiences and lower cost of care.”
The Azurion platform combines the tools required for complex interventional procedures with vital lab systems for an uncluttered lab environment.
SmartCT provides total control of the Azurion platform with a touchscreen tablet located next to the interventional radiology table, allowing clinicians to remain inside the sterile zone rather than using an adjacent control room.
07 april | covid-19
QIAGEN INTRODUCES NEW SARS-COV-2 SEQUENCING SOLUTION
QIAGEN has launched a viral genome enrichment and library preparation solution, QIAseq DIRECT SARS-CoV-2 Kit, which reduces library turnaround times and plasticware usage.
The solution supports sample multiplexing, with up to 768 Dual Molecular Indices in a library preparation workflow from extracted viral RNA that lowers turnaround time to four hours.
This aids in analysing more than 6,000 samples simultaneously on the highest-throughput sequencers.
Furthermore, the kit can be automated with robotic liquid handlers, helps to reduce plastic usage by 50% and hands-on time, and does not require fragmentation or ligation reactions.
When compared with commonly used amplicon-based options, this solution’s viral enrichment method offers greater uniformity of coverage across the SARS-CoV-2 genome as well as excellent sequencing performance.
06 april | approvals
ORTHOFIX 3D-PRINTED CERVICAL SPACER SYSTEM GETS FDA CLEARANCE
The US FDA has granted 510(k) clearance to Orthofix Medical’s 3D-printed CONSTRUX Mini Ti Spacer System, designed to facilitate anterior cervical discectomy and fusion procedures.
Made with nanoscale surface features, the CONSTRUX Mini Ti cervical spacer with nanovate technology has been implanted in the first patient.
The system has 3D-printed porous titanium with macro, micro and nanoscale surface features. In an in vivo ovine lumbar spinal fusion model, the nanoscale surface demonstrated an increase in proliferation and alkaline phosphatase activity in human stem cells in vitro.
The system also features endplates with 400-micron pores and 50% porosity designed to support bone ingrowth.
Furthermore, the functional gradient porous structure, with 80% porosity at the midline of the implant, facilitates better fluoroscopic visualisation.
06 april | testing
ETHOS UNVEILS SARS-COV-2 TEST TO DETECT EMERGING MUTATIONS
Ethos Laboratories has launched a new molecular test that can detect key virus strains of SARS-CoV-2, including the UK (B.1.1.7), South Africa (B.1.351) and Brazil (P.1) variants.
Estimates attribute 40% of new infections in some areas of the US to these variants, making precise detection vital for ongoing public health strategies.
At present, gene-sequencing technologies are used to carry out genomic surveillance of SARS-CoV-2 variants. However, these technologies are not suitable for high-throughput testing.
According to the Centers for Disease Control and Prevention, approximately ten days are needed to sequence a sample and add the findings to public databases.
There exists a vital need for high-throughput technologies which can precisely detect known or existing variants.
The Ethos Laboratories Matrix-Assisted Laser Desorption/Ionization-Time Of Flight mass spectrometry method can analyse up to 15,000 samples a day, with the results delivered in about six hours.
The new high-throughput test offering from Ethos covers three variants, which are classified as variants of concern by the US Department of Health and Human Services.
The company noted that this classification is only allocated when there is enough evidence that the variant in question shows higher transmissibility.
05 April | innovation
HARDY DIAGNOSTICS UNVEILS MATRIX-ASSISTED LASER INSTRUMENT
Hardy Diagnostics, in partnership with Autobio, has launched the Matrix-Assisted Laser Desorption/Ionized Time of Flight instrument.
The device, which is otherwise known as MALDI-TOF, offers high-speed detection and taxonomical classification of bacteria, yeasts and filamentous fungi based on proteomic fingerprinting.
The Autof MS 1000 has a database of approximately 5,000 species of microorganisms, created with more than 15,000 strains.
As compared with conventional methods and PCR, the instrument has faster time-to-result and accuracy similar to nucleic acid sequencing technologies.
05 april | approvals
FDA GRANTS 510(K) CLEARANCE TO NANOX’S DIGITAL X-RAY SYSTEM
The US FDA has granted 510(k) clearance to Israeli company NANO-X IMAGING’s (Nanox) single-source Nanox.ARC digital x-ray technology.
Nanox focuses on developing a commercial-grade digital X-ray source designed to be used in real-world medical imaging applications.
The company noted that its novel technology could considerably lower the costs of medical imaging systems and intends to partner with healthcare groups and companies to offer inexpensive, early detection imaging service.
On obtaining clearance, Nanox anticipates making the multi-source Nanox.ARC a commercial imaging system to be deployed widely across the world.
WHITE HOUSE LOOKS TO MINIMISE FEDERAL ROLE IN US ‘VACCINE PASSPORTS’
The Biden administration has dismissed the idea of a federal programme for so-called ‘vaccine passports’, and confirmed that there are no plans for a centralised Covid-19 vaccine database.
NEW REPORT PAINTS BRIGHT FUTURE FOR CONTACT LENS TECH
A newly-published paper in Contact Lens and Anterior Eye has reviewed innovative uses for contact lenses in disease detection and therapy, drug delivery, vision enhancement and more.
The paper represents one of the most comprehensive reviews of potential future advancements in contact lenses.
FDA AUTHORISES HELIUS’ NEUROMODULATION STIMULATOR FOR GAIT IMPROVEMENT
The US FDA has authorised the marketing of Helius Medical’s Portable Neuromodulation Stimulator as a short-term treatment for adults with gait deficit from mild to moderate multiple sclerosis.
A neuromuscular tongue stimulator, the device has a non-implantable apparatus to produce electrical pulses for stimulation of the trigeminal and facial nerves through the tongue to treat motor deficits.
UNIVERSITY TEAM USES AI TO DECODE ASBESTOS-LINKED CANCER
Researchers at the University of Leicester have used artificial intelligence to gain new insights into mesothelioma, a cancer caused by breathing asbestos particles that typically occurs in the linings of the lungs or abdomen.
BOSTON SCIENTIFIC’S THERASPHERE IMPROVES SURVIVAL IN LIVER CANCER STUDY
Boston Scientific has reported positive data from the TARGET study of the TheraSphere Y-90 Glass Microspheres in patients with hepatocellular carcinoma, a common type of primary liver cancer.
01 april | device development
ROCHE UNVEILS EBV IMMUNOASSAY PANEL TO DETECT INFECTION STAGES
Roche has launched the Elecsys Epstein-Barr Virus (EBV) panel, which consists of Elecsys EBV IgM, Elecsys EBV VCA IgG and Elecsys EBV EBNA IgG immunoassays, in countries accepting the CE Mark.
The panel uses a single blood sample to identify antibodies specific to EBV at various stages of infection.
When used together, the three tests can provide an understanding of how far the infection has progressed in a patient.
Needing a small sample volume of 6μL to 35μL, the immunoassays deliver a result in only 18 minutes.
Roche diagnostics CEO Thomas Schinecker said: “The tests help to provide the information clinicians need to diagnose and treat their patients quickly, effectively reducing the need for further confirmatory testing.”
Roche noted that EBV testing with immunoassays from a blood sample has numerous clinical benefits. EBV is used for confirming the diagnosis of glandular fever in individuals with clinical signs and symptoms while also ruling out other acute diseases with similar clinical pictures.
31 March | device development
MATMACORP UNVEILS HANDHELD PCR DEVICE FOR MOLECULAR DIAGNOSTICS
Materials and Machines Corporation (MatMaCorp) has introduced its new handheld device MY Real-Time Analyzer (MYRTA), which can carry out polymerase chain reaction (PCR) amplification and real-time fluorescent detection.
Weighing less than a pound and easily fitting in the hand, the device can identify DNA or RNA targets in an hour.
MYRTA was developed to offer portable, PCR-based molecular diagnostic solutions for human and animal health. Using the existing testing format, it can process a sample with up to three different tests and offer near quantitative data, including a cycle threshold value.
Based on fluorescence detection technology, the device can run isothermal or PCR conditions (cycling between various temperatures), based on the various requirements for identifying DNA or RNA.