FDA GRANTS EUA TO LABCORP’S SARS-COV-2 AND FLU DETECTION COMBO KIT

04 October | testing

The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to the combined at-home collection test kit for Covid-19 and influenza A/B from life sciences company LabCorp.

The new kit is intended for individuals aged two years and above and utilises Roche Cobas SARS-CoV-2 & influenza A/B test for use on the Cobas 6800/8800 Systems.

It is a multiplex reverse transcription-polymerase chain reaction assay that can simultaneously detect and differentiate the SARS-CoV-2, influenza A and influenza B viruses.

The Cobas SARS-CoV-2 & influenza A/B test uses nasal or nasopharyngeal swab samples, which can be collected from individuals with suspected respiratory infections.

It helps people to test for both flu and Covid-19 with the aim to prevent the risk of further spreading of the virus to others.

The kit uses a short nasal swab which makes it comfortable and easier for individuals to complete at-home sample collection.

01 october | device development

NORTHWESTERN UNIVERSITY RESEARCHERS DEVELOP NEW TESTING METHOD FOR COVID-19

Scientists at Northwestern University have developed an antigen-based Covid-19 testing method that offers highly accurate results in less than three minutes.

In a recent blind laboratory test, the new method showed 100% accurate results in five minutes or less than that from swab to signal.

Additionally, the high-sensitivity test is being developed as a swab test and a rapid exhaled breath detection test for Covid-19.

The rapid swab test method can identify the presence of multiple surface proteins on the virus by utilising a nanomechanical sensor platform and microcantilever technology.

It eliminates false-positive results and detects spike proteins prior to symptoms.

01 OCTOBER | testing

CUREBASE HELPS INBIOS TO OBTAIN FDA APPROVAL FOR SCOV-2 DETECT TEST

Curebase has supported InBios International in securing US FDA EUA for its SCoV-2 Detect IgG Rapid Test.

The company collaborated with InBios to test its Covid-19 rapid test, which is an in-vitro lateral flow chromatographic immunoassay.

The device is designed to detect IgG antibodies of SARS-CoV-2 in human serum, plasma, venous whole blood and fingerstick whole blood.

It is developed to identify individuals with an adaptive immune response to SARS-CoV-2, which indicates recent or prior infection.

Curebase noted that the IgG Rapid Test should not be used to identify or exclude acute SARS-CoV-2 infection.

01 octoBER | surgical devices

HOLOGIC LAUNCHES EXPANDED OMNI SUITE SURGICAL OFFERING IN EMEA

Medical technology firm Hologic has unveiled its expanded gynaecological surgical offering, Omni suite, in Europe, Africa and the Middle East (EMEA).

The expanded offering currently includes a versatile Omni 30° hysteroscope, the Omni Lok cervical seal and the Omni 5 French seal.

These products complement Hologic’s existing portfolio of gynaecological surgical solutions.

The Omni expansion optimises diagnostic and operative hysteroscopy by providing greater flexibility and choice for physicians.

The three interchangeable sheaths, ranging from 3.7mm to 6mm with 0° or the new 30° field of view options, provide improved diagnostic and operative versatility.

A long working length of 200mm helps in adapting the procedure to the patient’s anatomy. The system of interchangeable sheaths gives the convenience of seeing and treating with a single hysteroscope.

30 SEPTEMBER | software

WYSS CENTER OBTAINS CE MARK FOR EPIOS CLOUD SOFTWARE

Wyss Center has received the CE mark for Epios Cloud, its web-based brain data visualisation software that enables long-term brain monitoring aimed towards personalised treatment.

The software, which is marked Class I medical device, is an application to store, process and review neural signals, including ultra-long-term data, online.

It is designed to display and review electroencephalogram (EEG) recordings made by EEG devices using scalp and sub-scalp electrodes, heart rate and accelerometer measurements over months and years.

Through a web browser, Epios Cloud allows clinicians to access patient data anywhere and anytime.

The software also has the flexibility to connect to brain and other bio-signal recording devices over the web.

30 SEPTEMBER | diagnostics

UK DRI RESEARCHERS DEVELOP BLOOD TEST TO DETECT BRAIN DAMAGE

Scientists at the UK Dementia Research Institute’s (DRI) Research and Technology Centre based at Imperial College London have developed a blood test that could detect brain damage in individuals who have sustained traumatic brain injury (TBI).

The team conducted a multicentre study that enrolled more than 200 patients who had experienced moderate to severe TBI from eight key trauma centres in Europe.

The aim of the study was to detect a blood biomarker that could precisely indicate axonal damage in the brain after TBI.

Assessing the protein biomarker in the blood will offer an easier, precise way to predict clinical outcomes and could aid in detecting people at increased risk of developing dementia, UK DRI noted.

The researchers found that determining blood levels of neurofilament light offered a precise lasting prognosis for the patient.

In brief

THERMO FISHER SCIENTIFIC UNVEILS SALIVA COLLECTION KIT FOR SARS-COV-2


Thermo Fisher Scientific has introduced a new saliva collection kit.


The new Thermo Scientific SpeciMAX Stabilized Saliva Collection Kit includes an easy-to-use spill-resistant funnel as well as a screw cap to secure the sample after collection.

UNIVERSITY OF SOUTH FLORIDA STUDENTS DEVELOP NEW VENTILATOR


Three biomedical engineering graduates from the University of South Florida in the US have developed a lifesaving medical ventilator to support the Covid-19 crisis.


The patent-pending prototype device, Eucovent, allows two patients to be ventilated by a single machine.

SCREENING DEVICE PRECISELY IDENTIFIES AMBLYOPIA IN NIH-FUNDED STUDY 


The National Institutes of Health (NIH) in the US has reported that a handheld screening device was shown to precisely identify subtle misalignment of the eyes to detect children with amblyopia (lazy eye) in a study.

US FDA GRANTS EUA FOR ANP TECHNOLOGIES’ COVID-19 RAPID TEST KIT


The US FDA has granted an EUA for ANP Technologies’ NIDS Covid-19 Antigen Rapid Test Kit.


The test is a lateral flow immunoassay that is developed using ANP’s Nano-Intelligent Detection System platform technology for the detection of SARS-CoV-2 from direct nasal swabs.

STUDY FINDS MASIMO’S EMMA DEVICE EFFECTIVE IN PRETERM INFANTS


A new study at the Osaka Women’s and Children’s Hospital in Japan has shown that the EMMA Capnograph device from medical technology company Masimo could be effective for monitoring preterm infants, or neonates, who are on mechanical ventilation.


The portable EMMA device is designed for capnography in patients of any age.

30 SEPTEMBER | approvals

BIOTRONIK GETS FDA APPROVAL FOR DRUG-ELUTING STENT SYSTEM

Biotronik has received approval from the US FDA for its new Orsiro Mission bioabsorbable polymer drug-eluting stent system.

The same proprietary stent design and bioabsorbable coating with controlled drug release present in the Orsiro stent are featured in the new system.

The ultrathin strut design of the new Orsiro DES is said to be the thinnest available in the US.

29 SEPTEMBER | imaging

GE HEALTHCARE LAUNCHES FIXED X-RAY SYSTEM FOR RADIOLOGISTS

GE Healthcare has launched Definium Tempo, a new digital X-ray system, to reduce workflow burden and improve productivity for radiology departments.

The new fixed overhead tube suspension X-ray system is intended to be a ‘personal assistant’ to radiologists and technologists.

The device uses automation to reduce workflow burdens and help radiology departments boost patient care. It also reduces patient positioning time, physical workload, errors and image retakes.