06 july 2020
Researchers develops electricity-free centrifuge for Covid-19 testing
Researchers at Stanford University in the US have developed an electricity-free centrifuge to separate components in patient saliva samples for Covid-19 testing.
The innovation is expected to increase the accessibility of Covid-19 testing in poor regions of the world.
According to the reports, the Handyfuge device, which does not require electricity, spins sample-containing tubes at high speeds to separate the virus genome from patient saliva samples.
The device uses a mechanical strategy similar to the Dyno-torch flashlights to deliver centrifugal force with a kinetic input from the user.
Furthermore, the cheap centrifuge costs less than $5 per unit and can be assembled using easily available components.
The centrifuge enables clinicians and scientists to conduct a quick and cheap diagnostic technique called the LAMP assay to detect the presence of the coronavirus genome in patient saliva samples.
The assay does not require specialised equipment and can deliver results in less than an hour. It costs approximately $1 per reaction, using commercial reagents.
However, output in diagnostic methods is likely to vary based on viral genome detection in saliva samples.
The scientists said: “Centrifugation to separate the reaction inhibitors from the inactivated sample was shown to be an effective way to ensure reliable LAMP amplification.”
According to the scientists, the Handyfuge, combined with the assay from Cepko and Rabe, works reliably in detecting synthetic Covid-19 RNA down to 10-100 copies per microlitres in saliva.
They are reportedly planning to test the assay and Handyfuge in field settings to validate it.
06 july 2020
Magstim acquires EGI product portfolio from Royal Philips
Magstim has acquired the product portfolio of Electrical Geodesics (EGI) from health technology company Royal Philips.
The company will acquire EGI hardware, software and sensor nets assets and start managing its global sales, service and support. Philips will support the transition until the end of this year.
EGI develops non-invasive multimodal technologies to monitor brain activity and provide transcranial electrical stimulation in brain research.
EGI’s proprietary dense array electroencephalography (EEG) technology collects data from more electrodes than conventional EEG. The technology is used to evaluate the electrical activity in the brain.
Developed by EGI, Geodesic Sensor Net (GSN) can produce high-resolution data and is used worldwide by neuroscience researchers.
Magstim Group CEO Lothar Krinke said: “This adds high-density EEG to our product portfolio, supporting more than 1,200 research labs and clinics that focus on mental health, brain disorders and cognitive neuroscience.
“Magstim has been pioneering and advancing transcranial magnetic stimulation for 30 years. High-density EEG closes the loop for the development of a comprehensive system for non-invasive neuromodulation. Magstim and EGI share a legacy and passion for innovation in neuroscience.”
Following the acquisition, Magstim plans to maintain a presence in EGI’s Oregon office supported by its global offices in the UK, Netherlands and Minneapolis, US.
The company is the pioneer of transcranial magnetic stimulation, a non-invasive, outpatient therapy cleared by the Food and Drug Administration (FDA) for major depressive disorder.
06 JULY 202
CME America announces expanded infusion set recall
02 JULY 2020
Switchback Medical introduces new division for device development
US-based medical device contract design and manufacturing company Switchback Medical has created a new division called Switchback BioSim Innovations to expand its services.
The company plans to offer functional dynamic biosimulator model development, cell culture services and physician training through the new division.
Switchback BioSim Innovations aims to develop new preclinical models for device testing and training. It will improve the safety and efficacy of the devices and accelerate the development cycle, the company noted.
Furthermore, customers will be able to both develop and test their device through the new division. It is expected to encourage customers to create efficiencies in their interactions with the company.
Switchback Medical principal Brady Hatcher said: “We are extremely excited about this new venture. It allows our customer’s product development teams to get more clinically relevant and faster testing feedback.
“With the BioSim Innovations capability, we can now host development through physician training all here in one location.”
The currently available device test models offer either anatomy information or physiology information. Healthy specimens are typically used for most device testing, preventing accurate human data being used for clinical trials.
Switchback’s BioSim Innovations has the capacity to generate models that simulate pathological conditions that can be repaired by the devices being developed.
The increased sophistication of medical devices being invented requires improved models and training solutions that existing benchtop or animal models do not achieve, added the company.
Biosimulation models depend on the animal and human tissue to create functional models such as a pumping heart with working valves to evaluate a valve repair device or perfused tissues to analyse neurovascular catheter usability.
02 July 2020
Axonics obtains FDA approval for 3T full-body MRI scans
Axonics Modulation Technologies has received US Food and Drug Administration (FDA) approval for 3T full-body magnetic resonance imaging (MRI) conditional labelling for its r-SNM System under a premarket approval (PMA) supplement.
With the new approval, the device is the sacral neuromodulation (SNM) System available in the US with MRI compatibility for both 1.5T and 3T full-body scans.
The company acquired the regulatory approval for r-SNM System to treat faecal incontinence last year. It also received the European CE-Mark approval for MRI conditional labelling of the r-SNM System.
Axonics CEO Raymond Cohen said: “This FDA approval allows Axonics to provide healthcare professionals with more choices in selecting the optimal MR scanner for their patients’ imaging needs.
“We expect SNM to become the preferred therapy for patients suffering from overactive bladder and bowel dysfunction and we remain confident that our keen focus on innovation and increasing patient awareness will significantly expand the SNM market in the years ahead.”
Last month, Axonics was granted FDA approval for its SmartMRI wireless patient Remote Control for the r-SNM System.
Axonics focuses on developing implantable SNM devices for the treatment of urinary and bowel dysfunction.
These conditions significantly impact the quality of life and result from miscommunication between the bladder and the brain.
Almost 87 million adults in the US and Europe are estimated to suffer from overactive bladder. Faecal incontinence / accidental bowel leakage affects another estimated 40 million adults.
01 JULY 2020
Qure.ai receives FDA clearance for AI-based CT scan solution
India-based imaging artificial intelligence (AI) provider Qure.ai has received 510(k) clearance from the US Food and Drug Administration (FDA) for its head CT scan solution qER.
Qure.ai’s qER solution can be used for early triage of all critical abnormalities visible on routine head CT scans, including intracranial bleeds, mass effect, midline shift and cranial fractures. It plugs directly into the radiology workflow and prioritises critical cases on the worklist.
The solution considerably reduces the time taken to open critical scans. It helps to improve the patient outcomes for those with time-sensitive abnormalities.
The company noted that the qER solution has undergone extensive validation, including a 2018 peer-reviewed publication in The Lancet. It is also deployed at many hospitals and teleradiology providers worldwide.
Qure.ai co-founder and R&D head Pooja Rao said: “Patient outcomes depend directly on the onset-to-treatment time, especially for brain injuries. Every day doctors are required to weigh the benefits of a potentially life-saving surgery versus the risks of an intracranial bleed or other complication.
“The sooner they have in-depth information that helps them make that decision, the better for the patient. This is where qER plays a key role.”
More than 75 million CT scans are performed in the US every year with approximately 10,000 people dying within seven days of an emergency room discharge.
The new tool is aimed at offering a comprehensive high-quality imaging AI tool to assist healthcare providers with prioritisation and image interpretation, the company noted.
Qure.ai’s portfolio of medical imaging AI also includes CE-marked chest X-ray AI tool qXR and Covid-19 progression monitoring solutions for chest X-rays.
01 JULY 2020
Kardium to debut Globe Mapping and Ablation System in Europe
30 JUNE 2020
Masimo launches drug-free device to reduce opioid withdrawal symptoms
Masimo has introduced drug-free, non-surgical device Bridge to help with the reduction of symptoms associated with opioid withdrawal.
The new solution, which has been granted a Food and Drug Administration (FDA) De Novo classification, uses neuromodulation to reduce withdrawal symptoms.
Masimo’s solution includes a wearable, single-patient-use, percutaneous neurostimulator that can be placed behind the ear.
The device applies gentle electrical impulses to branches of the cranial nerves around the ear to reduce heightened neuron activity related to opioid withdrawal symptoms.
Opioid use, which also includes prescription opioids and heroin, kills many people in the US each year. Over 446,000 deaths were reported in relation to opioids from 1999 to 2018. 232,000 of these deaths were reportedly caused by the overdoses related to prescription opioids.
Painful and severe flu-like symptoms, which last up to two weeks, often accompanies opioid withdrawal. This makes voluntary discontinuation a challenging process for opioid users.
The fear of the physical and psychological effects of withdrawal acts as a barrier for patients with the opioid-use disorder (OUD), even in seeking treatment. Of the over two million people suffering from OUD in the US, less than 20% are said to be receiving the treatment.
By reducing withdrawal symptoms, Bridge helps patients with OUD to move from opioids into an appropriate treatment programme.
Masimo founder and CEO Joe Kiani said: “The opioid epidemic continues to impact millions of people around the world. Unassisted withdrawal from long-term use can be lengthy, extremely unpleasant, and there is a high risk of relapse.
“Effectively helping to reduce opioid withdrawal symptoms, which is what Bridge has been shown to do, is a critical first step toward successful illicit opioid cessation and treatment. This is the first tool that we are introducing to help with the opioid epidemic.”
The company noted that Bridge was found to reduce opioid withdrawal symptoms within 15-30 minutes in a clinical trial. It was also found to offer lasting relief for as long as it was applied, allowing opioids to leave the body.