Industry news
FDA GRANTS BREAKTHROUGH DESIGNATION TO MAGNUS’ NEUROSTIMULATION TECHNOLOGY
01 november | approvals
The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Magnus Medical’s neurostimulation technology for the treatment of major depressive disorder (MDD).
Developed based on the SAINT technology, the new, non-invasive Magnus System acts rapidly and is designed to treat MDD in people who have not sufficiently recovered after receiving antidepressant medication or other therapies.
Magnus Medical has exclusively licensed the SAINT technology from Stanford University for commercialisation.
According to an investigational randomised controlled trial published on the American Journal of Psychiatry website, the individually targeted neurostimulation technology relieved severe depression in 79% of people who received active treatment.
01 november | device development
SCOTLAND INTRODUCES NEW BLOOD TEST FOR TYPE 1 DIABETES PATIENTS
The government has introduced a new blood test for type 1 diabetes patients in Scotland that would improve the accuracy of diagnosis.
Offered at hospital diabetes centres, the C-peptide blood test allows some people to reduce or completely stop taking their insulin injections.
Scotland is claimed to be the first country to offer this blood test to patients who have had a type 1 diagnosis for at least three years.
According to the Scottish Government, approximately 315,000 people in the country are currently living with diabetes.
29 OCTOBER | device development
PHYSIQ, PURDUE UNIVERSITY PARTNER TO DEVELOP VIRAL DETECTION ALGORITHM
Digital medicine firm physIQ has collaborated with Purdue University for the development of a smartwatch-based algorithm to detect early viral infection signs, including signs of Covid-19.
As part of the partnership, physIQ will be responsible for the commercialisation of the algorithm. Purdue University biomedical engineering associate professor Craig Goergen led the research.
The research involved a study, which was conducted on 100 subjects, including Purdue students and staff, to determine whether wearing a smartwatch to gather data was practical and user-friendly.
29 octoBER | diagnostic devices
BD AND BARDA PARTNER FOR COMBINATION COVID-19 DIAGNOSTIC TESTS DEVELOPMENT
Becton, Dickinson and Company (BD) has collaborated with the US Biomedical Advanced Research and Development Authority (BARDA) on the development of a range of combination Covid-19-related diagnostic tests.
BARDA will provide $24.7m in initial funding to BD, which can be extended to $40.3m as part of the collaboration.
The funding will be utilised for the development and US FDA 510(k) clearance of five new tests.
These diagnostic tests will include the BD MAX System Respiratory Panel, BD COR System Respiratory Panel, BD Veritor Plus System Respiratory Panel, BD COR System Respiratory Panel plus Pan-Coronavirus, and BD MAX System Respiratory Panel plus Pan-Coronavirus.
BD stated that these panels cover testing in high-throughput laboratory, point-of-care and acute-care settings.
29 october | testing
OSU RESEARCHERS DEVELOP NEW RAPID BREATH TEST TO DETECT COVID-19
Researchers at the Ohio State University (OSU) Wexner Medical Center in the US have developed a new rapid breath test that can detect Covid-19 in critically ill patients.
They are exploring the use of the new Covid-19 breath test to expedite the screening process instead of using an invasive nasal swab.
The breath detector device was developed by The Ohio State University Department of Materials Science and Engineering and the Department of Mechanical and Aerospace Engineering researcher and professor Pelagia-Irene Gouma in collaboration with Stony Brook University Department of Electrical and Computer Engineering associate professor Milutin Stanaćević.
The new breathalyser was tested on 46 patients in the intensive care unit who were on ventilators due to respiratory failure.
Half of the patients that participated in the study had an active Covid-19 infection while the remaining individuals did not.
29 october | testing
FULGENT GENETICS INTRODUCES LAB-DEVELOPED COVID-19 ANTIBODY TEST
Fulgent Genetics has introduced a new lab-developed, at-home neutralising antibody test for Covid-19.
The finger prick test measures the neutralising antibody levels that prevent SARS-CoV-2 infection in vaccinated individuals as well as those with a recent infection.
This provides individuals with data regarding their potential resistance levels to Covid-19 and the long-term effectiveness of vaccines.
Fulgent stated that the neutralising antibodies bind to a specific part of a pathogen and have been observed to reduce SARS-CoV-2 viral infection of cells.
The US FDA-approved neutralising antibody detection device evaluates the risk of severe complications and monitors long-term immunity from the disease.
Fulgent will make the new test available through Picture Genetics, its consumer-initiated platform.
27 octoBER | diagnostics
USF HEALTH RESEARCHERS FIND D-DIMER TEST ALSO WORKS FOR COVID-19 PATIENTS
Researchers at the University of South Florida Health (USF Health) Morsani College of Medicine have found that the D-dimer test also works for Covid-19 patients.
The screening blood test, which was validated originally for seriously ill patients without Covid-19, is still useful to rule out pulmonary embolisms in hospitalised Covid-19 patients.
26 octoBER | cancer
ROCHE LAUNCHES GENOMIC PROFILING KIT TO AID CANCER RESEARCH
Roche has launched a new genomic profiling kit to help laboratories strengthen their in-house cancer research.
The new AVENIO Tumor Tissue Comprehensive Genomic Profiling Kit is a research use only sequencing assay developed to offer an end-to-end workflow from DNA extraction and library preparation to generation of variant results.
In brief
US FDA GRANTS 510(K) CLEARANCE FOR TRICE MEDICAL’S MI-EYE 3 NEEDLESCOPE
The US FDA has granted 510(k) clearance for Trice Medical’s single-use 25° mi-eye 3 needlescope. The single-hand device, with horizon levelling technology, is an orthopaedic imaging solution that helps physicians perform full diagnostic arthroscopy on a high-resolution mi-tablet 3.
LFTS FOR TRAVEL TESTING REPLACE PCRS IN ENGLAND
Fully vaccinated passengers arriving in England from countries not on the UK’s red list can now take a Covid-19 lateral flow test when entering the country, rather than a polymerase chain reaction test.
GENETRON AND JIANGSU FOSUN TO COMMERCIALISE MRD DETECTION TEST IN CHINA
Genetron Health has signed an exclusive agreement with Shanghai Fosun Pharmaceutical’s subsidiary Jiangsu Fosun Pharmaceutical to commercialise the Seq-MRD molecular diagnostic assay in China.
BAXTER, BIOMÉRIEUX OBTAIN CE MARK FOR ACUTE KIDNEY INJURY PREDICTION TEST
Baxter and in vitro diagnostics company bioMérieux have received CE Mark for the NEPHROCLEAR CCL14 Test designed for persistent severe acute kidney injury prediction. It is designed to be used together with clinical evaluation in adults with moderate or severe acute kidney injury.
NUS RESEARCHERS DEVELOP SMART BANDAGE TO MONITOR CHRONIC WOUNDS
Researchers at the National University of Singapore’s (NUS) Department of Biomedical Engineering and Institute for Health Innovation and Technology have collaborated with Singapore General Hospital’s clinical partners to develop a smart bandage for monitoring chronic wounds.
