Industry news
Trivitron Healthcare develops monkeypox virus detection test kit
30 MAY | Diagnostics
Medical devices firm Trivitron Healthcare has developed a real-time (RT) PCR-based kit for the detection of the monkeypox (orthopoxvirus) virus.
The new RT PCR kit is a four-colour fluorescence-based kit that helps to differentiate smallpox and monkeypox in a one-tube single reaction format.
Trivitron stated that the test kit has a total turnaround time for detecting the virus of approximately an hour.
The first gene in the four-gene RT-PCR kit detects the viruses in the wider orthopox group, while the second and third genes identify and differentiate the monkeypox and smallpox viruses, respectively.
The fourth gene detects the internal control corresponding to human cells to help track the epidemic spread of the virus.
Available as research-use only (RUO), the monkeypox RT PCR kit has been developed based on literature research and in-silico design.
3 JUNE | 3D Printing
3DBIO, MICROTIA-CONGENITAL EAR DEFORMITY INSTITUTE IMPLANT 3D-PRINTED EAR
3DBio Therapeutics and the Microtia-Congenital Ear Deformity Institute have conducted a human ear reconstruction using the AuriNovo implant, a 3D-bioprinted living tissue ear implant.
The investigational, 3D-bioprinted implant has been developed using a proprietary process that uses the patient’s own tissue to construct an implantable ear.
Developed using 3D-bioprinting technology, the patient-specific living tissue implant is intended for surgical reconstruction of the outer ear in people who are born with microtia Grades II-IV.
AuriNovo has been designed as an alternative treatment for microtia patients, who have been using rib cartilage grafts and synthetic materials for the reconstruction of the outer ear.
It has received Orphan Drug and Rare Pediatric Disease Designations from the US Food and Drug Administration (FDA).
31 MAY | CANCER
MD ANDERSON DEVELOPS ULTRASOUND-GUIDED MICROBUBBLES CANCER TREATMENT
The University of Texas MD Anderson Cancer Center researchers have developed the Microbubble-assisted UltraSound-guided Immunotherapy of Cancer (MUSIC) platform for improving antitumour immune and checkpoint inhibitor responses.
The new ultrasound-guided cancer immunotherapy platform generates systemic antitumor immunity and improves the therapeutic efficacy of immune checkpoint blockade.
Employing nanocomplexes combined with microbubbles, it provides cyclic guanosine monophosphate-adenosine monophosphate (cGAMP), an immunotransmitter involved in anticancer immunity, into antigen-presenting cells (APCs).
When given as monotherapy in breast cancer models, the MUSIC approach showed 60% of complete tumour eradication rate in the preclinical study.
31 MAY | AI
VITESTRO LAUNCHES AUTONOMOUS DEVICE FOR BLOOD COLLECTION
Dutch medical robotics company Vitestro has revealed an advanced autonomous blood drawing device.
The new device combines artificial intelligence (AI) and ultrasound-guided 3D reconstruction with robotic needle insertion to ensure the precise and secure collection of blood.
The blood drawing device is intuitive to use and empowers patients to be self-efficacious during the complete blood collection procedure.
It allows almost full automation of the pre-analytical phase of the process.
The laboratory automation technology has the potential to reduce high blood test error rates, which are mainly caused by manual variability.
Vitestro said that it has already performed 1,500 automated blood draws in more than 1,000 patients with its prototype in clinical studies.
27 MAY | ROBOTICS
MMI INTRODUCES NEW SIMULATOR FOR MICROSURGERIES
Medical Microinstruments (MMI) has introduced the Symani Surgical System Simulator to help surgeons hone their skills in a safe, simulated environment.
The new simulator is developed by medical simulation training company VirtaMed. It will support the training of surgeons who will use MMI’s Symani Surgical System to perform robotic microsurgeries.
The Symani Surgical System is a robotic platform with wristed instruments for microsurgeries. The device is designed to enhance a surgeon’s ability to access and suture small and delicate anatomy.
It uses technologies to scale movement and minimise tremor, enabling surgeons to make precise micro-movements. The system can be used to perform suturing, ligation, anastomoses, and coaptations.
According to MMI, the launch of the simulator will facilitate the adoption of robotic microsurgery.
30 MAY | DEALS
ANGLE, SOLARIS & MIDLANTIC UROLOGY SIGN PROSTATE CANCER STUDY DEAL
Liquid biopsy company ANGLE has signed agreements with Solaris Health and its affiliate MidLantic Urology to conduct clinical studies in prostate cancer.
ANGLE and MidLantic Urology will begin trials to evaluate the Parsortix system in prostate cancer.
The device is developed to detect the presence of prostate cancer and predict its severity in patients with an elevated prostate-specific antigen (PSA) level and/or abnormal digital rectal exam.
The first study design is expected to commence in the third quarter of the year and will draw on earlier pilot studies, which were independently conducted at the Barts Cancer Institute at Queen Mary University, London, UK.
Initially, 100 men at three study sites will be enrolled and will undergo a prostate tissue biopsy over an expected period of up to nine months.
31 MAY | CLINICAL TRIALS
ADSCC PLANS TO BEGIN MULTIPLE SCLEROSIS TREATMENT TRIAL
Abu Dhabi Stem Cells Center (ADSCC) has announced plans to commence a Phase I/II clinical study of Extracorporeal Photopheresis (ECP) technology to treat multiple sclerosis.
The new technology provides immunomodulatory effects and has been used in the treatment of advanced cutaneous T-cell lymphoma (CTCL) skin symptoms.
It has also been used to fight conditions that share some of the characteristics of multiple sclerosis.
7 JUNE | Product Launches
ETHICON LAUNCHES ECHELON 3000 STAPLER FOR SURGEONS IN US
Johnson & Johnson MedTech’s subsidiary Ethicon has launched the next-generation digitally-enabled ECHELON 3000 Stapler for surgeons in the US.
The new advanced surgical device has been designed to staple and transect different tissue types in open and minimally invasive surgical procedures.
It is designed with a 27% bigger articulation span and 39% bigger jaw aperture.
This allows surgeons to have better access and control over each transection, even on challenging tissue or in tight spaces.
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.
In brief
US FDA APPROVES ABBOTT’S FREESTYLE LIBRE 3 SYSTEM FOR DIABETIC PATIENTS
The US FDA has granted clearance to Abbott’s next-generation FreeStyle Libre 3 system for use by diabetic patients aged four years and above.
The new device, which includes a continuous glucose monitoring (CGM) sensor, recorded a 7.9% overall mean absolute relative difference (MARD) and is claimed to be the most accurate 14-day CGM system.
BURNING ROCK BIOTECH’S MULTI-CANCER DETECTION TEST RECEIVES CE MARK
Burning Rock Biotech has obtained CE mark for its OverC Multi-Cancer Detection Blood Test, a qualitative next-generation sequencing (NGS)-based in vitro diagnostic device.
Manufactured in the US and China facilities, the device has been designed to detect DNA methylation markers using cfDNA from human peripheral whole blood.
FDA GRANTS 510(K) CLEARANCE FOR ROYAL BIOLOGICS’ MAXX- BMC SYSTEM
The FDA has granted 510K clearance for Royal Biologics’ MAXX-BMC bone marrow aspirate concentration system.
The device has been designed for use at point of care setting to provide optimal samples of concentrated bone marrow aspirate (BMA) from a patient to users.
LUMIRADX OBTAINS CE MARK FOR NT-PROBNP TEST FOR CONGESTIVE HEART FAILURE
LumiraDx has obtained CE mark for its new NT-proBNP test, a rapid and easy to use microfluidic immunofluorescence assay, which is used for diagnosing congestive heart failure (CHF).
The device has been designed for measuring the NT-proBNP levels in human capillary, venous whole blood and plasma samples and can provide results in 12 minutes.
US FDA GRANTS 510K CLEARANCE FOR AURORA SPINE’S INTERBODY FUSION DEVICE
The FDA has granted 510K clearance for Aurora Spine’s DEXA SOLO-L anterior lumbar interbody fusion device (ALIF).
Based on the company’s DEXA Technology Platform, the 3D printed standalone device has been designed for anterior and lateral lumbar interbody fusion (ALIF & LLIF) procedures and is claimed to be the first device of its kind for the lumbar spine.
