Quanterix receives Breakthrough Device status for multiple sclerosis test
25 ApriL | Diagnostics
Quanterix has received Breakthrough Device designation from the US Food and Drug Administration (FDA) for its Simoa neurofilament light chain (NfL) plasma test for multiple sclerosis (MS).
The blood-based assay has obtained the designation as a prognostic aid for evaluating the disease activity risk in relapsing-remitting MS (RRMS) patients.
The digital immunoassay Simoa has been designed to quantitatively measure NfL in human serum and plasma.
Additionally, it can be used in conjunction with clinical, imaging and laboratory findings to identify RRMS patients at either lower or increased risk of relapse within four years.
Based on this information, the therapeutic approach for most effectively treating the disease can be determined.
The FDA’s designation follows a global study in which researchers at the University Hospital Basel and the University of Basel, Switzerland, established a new approach to enable clinicians to identify and interpret high sNfL values in individual MS patients using the Simoa technology from Quanterix.
26 APRIL | Product LaunchES
MEDLINE UNVEILS PLATING AND IMPLANT SOLUTIONS IN US
Medline UNITE Foot & Ankle has unveiled the Calcaneal Fracture Plating System and IM Fibula Implant solutions in the US.
With the launch of these products, surgeons will have access to a comprehensive titanium foot and ankle trauma system for addressing almost all fractures needing open reduction and internal fixation (ORIF) with plate and screw fixation.
Both products obtained clearance from the FDA.
Surgeons can use Medline UNITE Calcaneal Fracture Plating System to handle a wide range of fracture patterns, anatomical variations and surgical methods from one tray.
Several implant options including standard, offset, and extension Sinus Tarsi and Perimeter plates are part of the system.
25 APRIL | RecallS
PHILIPS RESPIRONICS RECALLS V60 VENTILATOR PRODUCT RANGE
Royal Philips’ subsidiary Philips Respironics has issued a voluntary recall notification/field safety notice to customers of its V60/V60 Plus and V680 ventilators.
The company has notified its customers regarding a potential issue with the electrical circuit that controls the 35V power supply to the ventilator and alarm.
The relevant competent authorities have already been informed regarding the issue.
Philips Respironics has identified that there is a chance that the affected ventilators may stop working without giving an audible/visual alarm, meaning the patient may not receive respiratory support.
Customers are being advised to implement measures to prevent the rare chance of the danger caused by the 35V electric circuit issue.
25 APRIL | ApprovalS
QVELLA OBTAINS CE MARK FOR FAST SYSTEM AND FAST-PBC PREP CARTRIDGE
Diagnostics firm Qvella has obtained a CE mark for its Field Activated Sample Treatment (FAST) System and FAST-PBC Prep Cartridge products to be used for in vitro diagnostic (IVD) in Europe.
The products have also been listed as Class I IVD devices by the FDA.
The company’s FAST-Technology eliminates the need for time-consuming culture methods, facilitates automation and accelerates different microbiology workflow stages to generate information for bloodstream infections.
It uses a new sample treatment method that enables the rapid isolation and concentration of bacterial cells in clinical specimens.
During the recent beta trials of the FAST System and FAST-PBC Prep Cartridge, Qvella’s fully automated FAST-Technology showed easy integration into existing workflows and required hands-on time of approximately two minutes.
22 APRIL | DEALS
WALLABY ACQUIRES GERMAN COMPANY PHENOX FOR $543M
Wallaby Medical has acquired German company phenox, including femtos, in a deal valued at nearly $543m (€500m), including milestone payments.
Established in 2005, phenox offers a portfolio of neurovascular devices for the treatment of both ischemic and haemorrhagic strokes.
The key product line of the company comprises the p64/p48 range of flow diverters, to treat intracranial aneurysms, and the pRESET range of stent retrievers for the mechanical thrombectomy of ischemic strokes.
Furthermore, phenox provides coating technologies to improve permanent and short-term implants.
Wallaby also acquired femtos, which acts as an incubator for advanced medical technologies, focusing on the development and manufacturing of next-generation neurovascular devices to treat stroke. It has capabilities in femto-second laser technology, allowing it to produce stents and other implantable devices.
21 APRIL | Diagnostics
DOMUS DIAGNOSTICS TO BEGIN CLINICAL TESTING OF COVID-19 PLATFORM
US-based firm Domus Diagnostics is ready to start clinical testing of its Covid-19 testing platform prototype.
The new SARS-COV-2 diagnostic test is designed to address the global need for accessible and rapid nucleic acid amplification tests (NAATs).
It is based on reverse transcription loop-mediated isothermal amplification (RT-LAMP) technology and aims to provide user-friendly, affordable and accurate infectious disease detection.
Domus will initially submit the test for approval through the World Health Organization (WHO). It will then be able to provide the test to governments and public health organisations in developing countries.
Upon completion of clinical trials, the company plans to also seek authorisation from the FDA for a multiplex test for Covid-19 and seasonal flu, as the Domus platform has the ability to detect multiple disease targets from a single sample.
20 January | Covid-19
WALGREENS LAUNCHES INTERACTIVE TOOL TO TRACK COVID-19 VARIANTS
Walgreens has launched a new interactive tracking tool, the Walgreens Covid-19 Index, to advance the rapid detection of Omicron and track variant activity. It says the index can track the spread of the omicron variant within 24 to 48 hours.
The tool uses testing data from Aegis Sciences Corporation and uniquely identifies the spread of current and emerging virus variants in real-time.
The tool offers a snapshot of data for the past seven days based on positive tests analysed at more than 5,000 Walgreens locations across the nation.
According to the data collected and tracked by the tool, more than 95% of all positive cases of Covid-19 nationally are presumed to be the Omicron variant.
18 APRIL | Wearables
NHS TO PROVIDE SMARTWATCHES TO PARKINSON’S PATIENTS FOR MOVEMENT MONITORING
The National Health Service (NHS) in the UK has announced that Parkinson’s patients will receive smartwatches which allows doctors to evaluate their condition remotely.
The gadget, called Parkinson’s Kinetigraph (PKG), was developed by NHS, together with University Hospitals Plymouth Trust and University of Plymouth.
PKG comprises sensors and helps to monitor the movements of the patients from the comfort of their homes. It also provides buzzes to remind patients to take their medicines.
19 APRIL | AI
AUSTRALIAN TGA APPROVES IHEALTHSCREEN’S IPREDICT AI EYE SCREENING SYSTEM
The Australian Health Therapeutic Goods Administration (TGA) has granted approval to iHealthScreen’s iPredict automated AI eye screening system.
The AI system is designed for the early diagnosis of diabetic retinopathy (DR), age-related macular degeneration (AMD), and glaucoma suspect, including retinal imaging.
It enables primary care, as well as various speciality practices, to accurately test diabetic patients for DR, people over 50 for AMD, and people with a family history of glaucoma, or other risk factors, for suspected glaucoma.
US FDA APPROVES BOSTON SCIENTIFIC’S IMAGE-GUIDED SOFTWARE FOR DBS
The FDA has granted approval to Boston Scientific’s Vercise Neural Navigator with STIMVIEW XT, the next-generation image-guided programming software for deep brain stimulation (DBS) therapy.
STIMVIEW XT has been developed in collaboration with software-driven medical technology company Brainlab.
It allows clinicians to visualise real-time lead placement and stimulation modelling of brain anatomy for Parkinson’s disease or essential tremor patients.
US FDA GRANTS 510(K) CLEARANCE FOR SONOSCAPE’S ENDOSCOPY SYSTEM
The FDA has granted 510(k) clearance to SonoScape’s HD-550 endoscopy system for gastrointestinal diagnosis.
The video endoscopy system is paired with a 4-LED light source that supports 1080P high definition and enables multi-mode as well as multi-spectrum.
It allows to capture and record images and videos and access patient data for creating and editing reports without the need of any extra software.
US FDA GRANTS EUA FOR MICROGEM’S SARS-COV-2 SALIVA TEST
The FDA has granted emergency use authorization (EUA) for MicroGEM’s Sal6830 SARS-CoV-2 Saliva Test.
The test is claimed to be the nation’s first FDA approved saliva test for Covid-19 that uses polymerase chain reaction (PCR) directly at the point of care, providing results in 27 minutes.
MicroGEM stated that the Sal6830 SARS-CoV-2 Saliva Test was clinically evaluated during the Delta and Omicron waves of the pandemic and has proven to be robust to viral mutations.
HEALTH CANADA APPROVES CLARIUS’ WIRELESS ULTRASOUND SCANNERS
Health Canada has granted approval for medical technology company Clarius Mobile Health’s third-generation product line of high-performance handheld ultrasound scanners.
These scanners can be connected wirelessly to a clinician’s Apple or Android smart device using artificial intelligence (AI)-driven application.
With the latest approval, the pocket-sized scanners are now available across the country with new features.