ABBOTT RECEIVES CE MARK APPROVAL FOR CARDIAC MAPPING PLATFORM

03 November | Device development

Abbott has received CE Mark and approval in Australia for its new cardiac mapping platform, EnSite X EP System, and is set to launch it throughout Europe and Australia. EnSite X EP System is a novel cardiac mapping system developed with inputs from electrophysiologists portfolio to enhance cardiac ablation procedures.


The system provides an option to navigate the cardiac anatomy in two different ways on a single platform. It can improve the way physicians deliver ablation therapy when treating abnormal heart rhythms.


With advanced imaging capabilities, the system can create a three-dimensional (3D) model of the patient’s cardiac anatomy in real time. It will enable physicians to spot areas of the heart that need ablation treatment. Physicians can use traditional impedance monitoring or electromagnetic technology, which helps to precisely locate Abbott’s sensor-enabled catheters during treatment.


Cardiac ablation is a minimally invasive procedure used to treat abnormally fast heartbeats by creating ablations in small areas of heart tissue that is causing the arrhythmia.


IRCCS San Raffaele Hospital, Italy Cardiac Electrophysiology and Arrhythmology Department head professor Paolo Della Bella said: “The new EnSite X System will fundamentally change how physicians approach longer, more complex ablation procedures as a result of its improved stability, faster mapping, and better model visualisation.


“In my first cases with the system, it’s been apparent that the system is an important step forward in terms of technological capabilities and also truly helps improve my clinical analysis by protecting for patient movements.”


Earlier, Abbott secured Food and Drug Administration (FDA) and CE Mark approval for the EnSite LiveView Dynamic Display, which enables data visualisation from the Advisor HD Grid mapping catheter, Sensor Enabled, in real time during cardiac ablation procedures.

03 november | approvals

FDA APPROVES BOSTON SCIENTIFIC’S RANGER DRUG-COATED BALLOON


Boston Scientific has received the approval of the FDA for the Ranger Drug-Coated Balloon (DCB) to treat patients with peripheral artery disease (PDA) in the superficial femoral artery and proximal popliteal artery.


PAD is a circulatory problem, in which plaque builds up in arteries. It leads to narrowing of arteries and reduced blood flow to limbs.


The Ranger DCB has a low therapeutic drug dose and coating, which transfers the drug into the tissue.


It results in high primary patency rates and low systemic drug exposure for patients.

With the low-profile platform of the balloon, clinicians will be able to perform streamlined procedures and navigate smoothly through challenging anatomy to provide consistent therapy.


The FDA approval is backed by results from the RANGER II SFA trial, which evaluated the Ranger DCB’s safety and effectiveness versus standard percutaneous transluminal angioplasty in PAD patients.

30 October | Clinical trials

BOSTON SCIENTIFIC STARTS TRIAL OF WATCHMAN FLX LAAC DEVICE


Boston Scientific has begun the CHAMPION-AF clinical trial to analyse the safety and efficacy of the WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device for patients suffering from non-valvular atrial fibrillation (NVAF).


The WATCHMAN FLX LAAC device will be compared to treatment with non-vitamin K antagonist oral anticoagulants, which are considered to be contemporary drugs for stroke risk reduction in this population.


Approximately 33 million people across the world suffer from atrial fibrillation (AF), a common heart rhythm disorder, which makes people suffering with this condition five times more likely to have a stroke than those with a normal heart rhythm.  In patients suffering with NVAF, over 90% of heart-related blood clots form in the left atrial appendage.


The device was designed to permanently close off this area of the heart, offering a one-time solution for those requiring an alternative to anticoagulation to reduce the risk of a stroke.

28 October | Covid-19

P&G HEALTH’S NASAL GEL TECH SHOWS POTENTIAL AGAINST COVID-19


A study conducted by P&G Health, the healthcare division of The Procter & Gamble Company, has found that its nasal mucoadhesive gel technology could reduce SARS-CoV-2 coronavirus infection of cells.


The company’s nasal mucoadhesive gel technology works as an intranasal spray. It was originally intended for use against common cold viruses. A standard antiviral laboratory test was carried out by the research team at the P&G Health to assess the technology’s ability to prevent the SARS-CoV-2 virus from infecting cells it needs for replication.


During the test, the nasal mucoadhesive gel formulation was combined with the virus for one, five, and ten minutes. These mixtures were added to cell monolayers and virus quantity was then assessed from the cells after a seven-day incubation. It was found that the nasal mucoadhesive gel reduced the level of SARS-CoV-2 viruses by 99.5% at one-minute exposure. The test showed greater reductions with five and ten minutes of exposure.


According to the company, this suggests the nasal mucoadhesive gel may reduce SARS-CoV-2 virus infection of cells. However, it noted that further clinical research is required to confirm whether the technology can offer a protective benefit against SARS-CoV-2 in humans.

27 October | digitial health records

INDUCTION ASSISTS NHS HOSPITAL TRUST ROLL OUT HEALTH RECORDS ON IPHONE


Milton Keynes University Hospital NHS Trust (MKUH) has partnered with healthcare technology company Induction Healthcare to launch health records of its patients on iPhone.


The company’s Zesty platform, which works in collaboration with Apple and health IT services group Cerner Corporation, has been used for the new initiative. MKUH is one of the first two NHS hospital trusts to roll out ‘health records on iPhone’ feature in the UK.


The integration will enable patients to receive a centralised view of their allergies, conditions, immunisations, lab results, medications, procedures and vitals.

26 October | device development

CANON MEDICAL INTRODUCES LB CT SCANNER FOR ONCOLOGY WORKFLOWS


Canon Medical Systems USA is set to introduce the Aquilion Exceed LB CT system with the latest simulation capabilities for radiation oncology.


The system, which is yet to obtain 510(k) market clearance, is developed to provide radiation oncologists with fast radiation oncology workflows.


It features 90cm large bore opening, 90cm field-of-view, as well as 4cm reconstruction and wide detector coverage.


Additionally, Aquilion provides sharp, clear and distinct images, leveraging Canon Medical’s Advanced intelligent Clear-IQ Engine Deep Learning Reconstruction technology.

In brief

HOLOGIC RECEIVES US CONTRACT TO SCALE-UP COVID-19 TEST PRODUCTION

Hologic has secured a $119m contract from the US Government to scale-up its production capacity for molecular tests for Covid-19. According to the contract, the company will provide 13 million Covid-19 molecular tests a month to the US by January 2022.

PRENETICS’ DNAFIT LIFE SCIENCES ACQUIRES OXSED

Prenetics’s wholly owned UK entity DNAFit Life Sciences has acquired social venture company Oxsed to accelerate efforts of fighting Covid-19. With this deal, DNAFit and Prenetics have gained exclusive global rights to Oxsed technology.

BD WINS RAPID COVID-19 ANTIGEN TEST SUPPLY ORDER FROM NETHERLANDS

Becton, Dickinson and Company has received an order from the Dutch Ministry of Health for 9.2 million of its SARS-CoV-2 antigen tests for use on the BD Veritor Plus System. The rapid, point-of-care tests can detect the virus in symptomatic patients in approximately 15 minutes.

MASIMO TO ACQUIRE HEMODYNAMIC MONITORING DEVICES MAKER LIDCO

Masimo has signed an agreement to acquire entire issued and to be issued share capital of LiDCO Group in a deal valued at approximately £31.1m ($40.1m). According to the agreement, Masimo will offer £0.12 per share to LiDCO, an advanced hemodynamic monitoring devices maker.

MEDTRONIC RECEIVES FDA APPROVAL FOR NIM VITAL NERVE MONITORING SYSTEM

Medtronic has secured FDA 510(k) clearance of the NIM Vital nerve monitoring system, which enables doctors to identify, confirm, and monitor nerve function to help cut down the risk of nerve damage during head and neck surgery.

29 October | Approvals

FDA CLEARS COGNITA LABS’ HOME-USE LUNG ASSESSMENT DEVICE


The FDA has cleared Cognita Labs’ PulmoScan, a home-use lung assessment device that measures airway resistance and elastance.


The device offers an alternative to existing lung tests. It sends gentle pressure waves to spot airway blockage and stiffening walls in the lungs.


The oscillometry method, the underlying technique in the system, has been studied and validated over many decades, the company noted.


Nearly 10% of the population suffer from respiratory conditions such as asthma and chronic obstructive pulmonary disease.

Generally, the lung test involves a forceful spirometry test, which is difficult to perform on young children and elderly patients.

28 October | imaging

EON USES COMPUTATIONAL LINGUISTICS TO IDENTIFY PULMONARY NODULE


US-based health-tech company Eon has announced that it is leveraging data science platform to identify incidental pulmonary nodules (IPN) on magnetic resonance (MR) and X-Ray radiology reports.


The company’s Essential Patient Management (EPM) platform is an all-inclusive lung cancer screening and IPN identification management solution.

The platform uses computational linguistics to identify incidental pulmonary nodules on computed tomography reports with 98.95% accuracy and 97% accuracy on MR and X-Ray radiology reports.


Additionally, EPM draws out clinically relevant findings from radiology reports. The expanded capability of the platform is expected to help facilities in capturing approximately 25% more incidental pulmonary nodules and equip them to spot lung cancer earlier.


The use of computational linguistics enables healthcare providers to positively identify and track incidental pulmonary nodules with better accuracy compared to other forms of artificial intelligence, such as natural language processing and computer-aided detection.


In brief

Chumakov Center initiates Covid-19 vaccine candidate trials

Russia’s Chumakov Center has started clinical trials of its potential Covid-19 vaccine in St Petersburg. The 30 participants are healthy volunteers aged 18-45 years who tested negative for Covid-19 and with the absence of antibodies to the virus.

Edesa Biotech gets FDA approval to trial EB05 for Covid-19 treatment

Edesa Biotech has received FDA approval to initiate Phase II clinical trial of its investigational drug EB05 to treat hospitalised patients with Covid-19. EB05 treatment aims to suppress fluid accumulation, lung injury and inflammation.

Dr Reddy’s and RDIF receive DCGI approval for Sputnik V human trial

Dr Reddy’s Laboratories and Russian Direct Investment Fund (RDIF) have received approval from the Drug Control General of India (DCGI) to conduct a Phase II/III human trial of Sputnik V Covid-19 vaccine in India. 

Russia grants approval to second vaccine for Covid-19

Russian health authorities have approved the Covid-19 vaccine EpiVacCorona, developed by the Vector State Virology and Biotechnology Center in Siberia. Researchers tested the vaccine in Phase I and II trials prior to receiving provisional registration.

FDA approves ImmunityBio Phase I Covid-19 vaccine trial

ImmunityBio has received FDA clearance to initiate a Phase I trial of its novel Covid-19 vaccine candidate, hAd5-COVID-19, which is engineered to activate T-cells and antibodies against SARS-CoV-2.