COMPUTERISED BRAIN IMPLANT REDUCES PAIN IN NYU LANGONE’S STUDY
22 June | implants
Researchers at NYU Langone’s Grossman School of Medicine have found that a computerised brain implant could efficiently alleviate short-term and chronic pain in a new preclinical study.
This data could be a ‘blueprint’ for creating brain implants to treat pain syndromes as well as other brain-based disorders, including anxiety, depression and panic attacks, the scientists noted.
According to the study, rodents with the implant withdrew their paws 40% more slowly from sudden pain as against times when the device was switched off.
This indicates that the computer-controlled device lowered the pain intensity experienced by the animals, study authors said.
Furthermore, rodents in sudden or continuous pain spent more time in a chamber where the device was turned on by nearly two-thirds compared to a chamber where the device was off.
Using closed-loop brain-machine interface technology, the implant senses brain activity in the anterior cingulate cortex, a brain region vital for pain processing.
Subsequently, a computer connected to the device automatically detects electrical patterns in the brain closely associated with pain.
On detecting signs of pain, the computer induces treatment stimulation of the prefrontal cortex region of the brain, to relieve the pain.
Furthermore, the device works only in the presence of pain, thereby lowering the risk of overuse and possible tolerance in the future.
Unlike opioids, the implant offers no further rewards, so would provide pain relief with a low risk of addiction.
In the study, the implant was able to precisely detect pain up to 80% of the time, the institute noted.
21 june | device development
INDIA’S IISC CREATES DIAGNOSTIC TEST FOR SICKLE-CELL DISEASE
A team of researchers at the Indian Institute of Science (IISc) has created a diagnostic test for identifying sickle cell disease (SCD) and sickle cell trait.
A genetic disorder of the red blood cells, SCD causes recurrent episodes of debilitating pain.
The test was developed by a team led by IISc professor Sai Siva Gorthi in partnership with Dr Nisanth Nambisson from the Government Homeopathy medical college (GHMC), Bhopa, India.
It could become a low-cost alternative to high-performance liquid chromatography (HPLC) analysis, which is time-consuming as well as being priced between $5.39 (Rs400) and $9.43 (Rs700).
Named HPOS, the absorbance spectroscopy-based test leverages an algorithm based on machine learning to classify samples.
It utilises low-cost reagents and a movable spectrometer to deliver results in 15 minutes.
21 June | AI
UNIVERSITY OF CHICAGO REPORT DETAILS SCOPE OF HEALTHCARE ALGORITHMIC BIAS
A report published by the Center for Applied Artificial Intelligence at the University of Chicago Booth School of Business has found that algorithms used to inform healthcare delivery and planning across the US are reinforcing racial and economic biases.
The Algorithmic Bias Playbook details how biased algorithms are influencing how patients are treated by hospitals, insurers and other businesses.
The playbook sets out a plan of action healthcare organisations can take to create an inventory of their algorithms, screen them for bias, adjust them or scrap them if the bias cannot be fixed and set up structures to prevent future bias.
The report flags biases in algorithms that: determine the severity of knee osteoarthritis; measure mobility; predict the onset of serious illness; and identify which patients may fail to attend appointments or may benefit from additional outreach to manage their health.
21 JunE | Approvals
CO-DIAGNOSTICS OBTAINS CE MARK FOR SARS-COV-2 SALIVA TEST
Co-Diagnostics has obtained CE mark to market its Logix Smart SARS-CoV-2 DS (Direct Saliva) as an in vitro diagnostic (IVD) for Covid-19 detection.
The test checks for the presence of the ribonucleic acid (RNA)-dependent RNA polymerase (RdRp) and E genes of SARS-CoV-2 in human saliva samples that are slightly processed.
It eradicates the need for RNA extraction from the samples, which is an expensive and time-consuming method used by many polymerase chain reaction (PCR) tests.
Co-Diagnostics noted that removing the extraction process could potentially boost throughput and reduce costs of testing for Covid-19 as well as other pathogens.
With the latest development, the new test will be available in all CE mark compliant markets and can also currently be purchased from the Co-Diagnostics Utah-based site in the US.
Co-Diagnostics CEO Dwight Egan said: “Our unique CoPrimer technology utilised in this test design received initial patent protection in 2018, which was further strengthened by an additional patent last year.
“In combination with this technology, direct saliva testing will play a key role in our ongoing centralised lab initiative, as well as our forthcoming at home and point of care testing strategies.”
21 JUNE | approvals
FDA GRANTS EUA TO ROCHE’S 20-MINUTE COVID-19 PCR TEST
Roche has received Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for the use of its cobas SARS-CoV-2 Nucleic acid test in point of care settings.
Indicated for screening symptomatic as well as asymptomatic people, the singleplex real-time reverse transcriptase-polymerase chain reaction (RT-PCR) test can detect Covid-19 infections in 20 minutes.
The test could aid in the making of rapid, informed decisions at doctors’ offices, screening sites and emergency or primary care, as well as other point of care settings.
Authorised for use on the cobas Liat System, the test will be made available in markets accepting the FDA EUA and CE mark in July.
Roche Diagnostics Solutions point of care head Ian Parfrement said: “We learn more about Covid-19 every day and Roche continues to develop solutions that will help healthcare systems around the world slow and eventually defeat this pandemic.
“Preventing further spread of the virus is crucial for public health and the continued safe reopening of our communities worldwide.”
15 june | trials
EXTHERA TO START TRIAL OF BLOOD PURIFICATION DEVICE FOR SEPSIS
ExThera Medical is set to commence a trial to analyse its Seraph 100 Microbind Affinity Blood Filter, a blood purification device that could potentially be used to treat sepsis among others.
The Seraph 100 has demonstrated the ability to lower both bacterial and viral loads in the bloodstream.
So far, the device has been used on more than 300 Covid-19 patients in the US and the European Union since April last year.
Authorised for emergency use, the device was found to lower mortality in severe cases of Covid-19.
ExThera obtained conditional approval from the US Food and Drug Administration to conduct the randomised, control, multicentre PURIFY-RCT study to treat critically ill subjects with pathogen-associated shock, a type of septic shock.
The study will assess the safety and efficacy of Seraph 100 blood purification treatment in subjects enrolled at various health centres in the US.
Analysing the efficiency of Seraph 100 against a variety of bloodstream infections that can cause sepsis will be the trial’s goal.
US REGULATOR WARNS AGAINST USE OF INNOVA SARS-COV-2 TEST
The US FDA has warned the public against the use of Innova Medical Group’s SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic purposes.
The agency did not authorise, clear or approve the test for commercial supply or use in the country.
FDA APPROVES MEDTRONIC’S VANTA SPINAL CORD STIMULATOR
Medtronic has secured approval from the US FDA for its Vanta device, a recharge-free implantable neurostimulator.
NAVIGATION SCIENCES STARTS CLINICAL FEASIBILITY TRIAL OF NAVISCI SYSTEM
Navigation Sciences has commenced the first-in-human clinical feasibility trial of its NaviSci System, which is used for tissue-conserving removal of early-stage lung tumours.
The Intelligent Surgery System is designed to provide real-time ‘GPS’ guidance to the surgeon, providing precise knowledge of where the target tumour and surrounding tissue are in relationship to surgical instrumentation.
AUSTRALIAN TGA APPROVES GLAUKOS’ PRESERFLO MICROSHUNT
The Therapeutic Goods Administration (TGA) of Australia has approved Glaukos’ PRESERFLO MicroShunt for lowering intraocular pressure (IOP) in eyes of people with primary open-angle glaucoma.
The device is indicated for patients whose IOP is not controlled using maximum tolerated medical treatments and/or when glaucoma progression requires a surgical procedure.
US FDA APPROVES CYMEDICA’S INTELLIHAB SYSTEM TO TREAT KNEE OSTEOARTHRITIS
CyMedica Orthopedics has secured approval from the US FDA for its Intellihab system, a non-invasive modality to treat knee osteoarthritis pain.
The home-based therapeutic and digital health ecosystem has been designed to treat pain that is associated with the debilitating osteoarthritis disease.
14 june | Device development
INDIA’S IIT ROPAR CREATES A SUBSTITUTE DEVICE FOR CPAP MACHINE
Indian Institute of Technology (IIT) Ropar has created a device called ‘Jivan Vayu’ that can be used as an alternative for continuous positive airway pressure (CPAP) machine.
CPAP is a treatment technique used for patients with breathing difficulties during sleep, a condition called sleep apnoea. Using mild air pressure, the CPAP machine keeps the airways open to aid breathing.
It is also used for treating infants whose lungs are not fully developed.
The machine is required during the initial stages of Covid-19 disease to mitigate lung damage and help patients recover from the inflammatory effects.
The new CPAP device does not require electricity and can be modified to both oxygen cylinders and oxygen generation pipelines in hospitals.
It is said to be leak-proof, cost-effective and made for a 22mm CPAP closed-circuit tube. The CPAP delivery system can also be modified according to tube size.
Furthermore, the device runs even during power failures and could be used during the transport of a patient.
14 june | recalls
PHILIPS RECALLS SLEEP AND RESPIRATORY CARE PRODUCTS OVER HEALTH RISKS
Royal Philips has voluntarily recalled breathing devices and ventilators after it found possible health risks linked to the polyester-based polyurethane (PE-PUR) sound abatement foam used in these products.
The recalled products are Bi-Level Positive Airway Pressure (Bi-Level PAP), CPAP and mechanical ventilator devices.
Most of these devices within the recommended five-year service life are part of the first-generation DreamStation product line, the company noted.
So far, millions of Philips’ Bi-Level PAP, CPAP and mechanical ventilator devices have been made using the PE-PUR sound abatement foam. The recall will target three to four million devices, Reuters reported citing the company’s CEO.
According to the company, the foam could degrade into small particles that can enter the air pathway of the device and be consumed or inhaled by the user.