Medtronic announces separation of combined businesses
24 October | DEALS
Medtronic has unveiled plans to separate its combined Patient Monitoring and Respiratory Interventions businesses (NewCo).
The businesses are part of the Medical Surgical Portfolio of Medtronic.
The company has taken this decision in order to create value for all of its stakeholders and focus more on strategic priority areas as well as execute its leadership strategy in the medtech markets that leverage its strengths.
After the separation of NewCo, Medtronic is expected to have a more streamlined portfolio and modestly faster organic revenue growth, as well as an improved balance sheet.
Medtronic believes that the new entity will help deliver expanded value creation through global scale and commercial reach along with connected care solutions.
The Patient Monitoring technology portfolio will consist of Nellcor pulse oximetry, Microstream capnography, BIS brain monitoring, INVOS perfusion monitoring and HealthCast connected care solutions.
The Respiratory Interventions technology portfolio will comprise Puritan Bennett ventilators, Shiley airway portfolio, McGrath MAC video laryngoscopy and DAR breathing systems, as well as the PAV+, NIV+ and IE Sync ventilation software solutions.
Medtronic chairman and CEO Geoff Martha said: “We are executing on our portfolio management strategy, taking action to create value for Medtronic and our shareholders."
19 October | Deals
BD AND MAGNOLIA MEDICAL PARTNER TO COMMERCIALISE STERIPATH PLATFORMS
Becton, Dickinson and Company (BD) has signed a co-exclusive commercial agreement with Magnolia Medical Technologies to help reduce blood culture contamination and improve testing accuracy in US hospitals.
Under the deal terms, both companies will jointly sell and market Magnolia Medical’s Steripath and Steripath Micro Initial Specimen Diversion Device platforms.
BD stated that the two platforms would complement its specimen collection portfolio, which includes the BD Vacutainer push button and BD Vacutainer UltraTouch blood collection sets.
Steripath is claimed to be the only device platform, which has received 510(k) clearance from FDA.
It has been specifically designed to reduce blood culture contamination for sepsis testing accuracy.
25 October | Devices
ROCHE’S RT-PCR TEST RECEIVES FDA 510(K) CLEARANCE
Roche Diagnostics has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its cobas SARS-CoV-2 Qualitative PCR test.
The new real-time RT-PCR test has been designed for the qualitative detection of nucleic acids from SARS-CoV-2 in nasal and nasopharyngeal samples collected from symptomatic individuals.
With the ability to run on the fully automated cobas 6800 and cobas 8800 Systems, the test also has a full-process negative control, positive control and internal control.
The single-well dual target assay includes specific detection of SARS-CoV-2, as well as pan-sarbecovirus detection for the sarbecovirus subgenus that has SARS-CoV-2.
It is claimed to be the first commercial molecular test to receive FDA 510(k) clearance.
11 October | DEALS
MICROBOT MEDICAL ACQUIRES FDA-APPROVED DEVICES OF NITILOOP
The acquired assets comprise the NovaCross family of microcatheters, including NovaCross CTO, NovaCross Xtreme and NovaCross BTK.
These devices enable the intraluminal placement of conventional and steerable guidewires beyond stenotic lesions, including chronic total occlusions (CTO), before percutaneous transluminal coronary angioplasty (PTCA) or stent intervention.
The NovaCross microcatheter family can be used as standalone devices or incorporated into Microbot Medical’s One & Done technology. They are also anticipated to form a collection of customised procedure-related kits for the LIBERTY Robotic System.
19 October | Deals
LUCENCE PARTNERS WITH OMNIGEN TO DISTRIBUTE CANCER BLOOD TESTS IN TURKEY
Lucence and laboratory diagnostics distributor Omnigen have entered a new partnership to bring amplicon-based liquid biopsy tests for cancer to Turkey.
Under the deal terms, Omnigen will be responsible for distributing Lucence’s liquid biopsy tests to Turkish hospitals and clinicians.
The company will distribute Lucence’s LiquidHALLMARK next-generation sequencing (NGS) assay. The assay targets circulating DNA and RNA to profile the unique cancer of a patient.
26 October | Regulation
FDA GRANTS 510(K) CLEARANCE FOR NEUROONE’S EVO SEEG ELECTRODE TECHNOLOGY
This approval will allow the company to market its Evo sEEG System for temporary use, which is for less than 30 days, with monitoring, recording and stimulation equipment.
The system can be leveraged for monitoring, recording and stimulating the electrical signals at the subsurface level of the brain.
18 October | Devices
ABIOMED SECURES FDA 510(K) APPROVAL FOR LOW PROFILE SHEATH
The sheath with modern technological features will cut down procedural steps and enable smooth Impella insertion and removal, resulting in enhanced outcomes.
While the Low Profile Sheath has the same inner diameter as the 14 French (Fr) sheath used for Impella CP placement, it features a reduced outer diameter by around 2Fr.
The new sheath is the first of its type to be compatible with the Impella single-access technique, which helps eliminate the need for another access site.
26 OCTOBER | TRIALS
SEQUANA MEDICAL REPORTS POSITIVE DATA FROM ALFAPUMP SYSTEM TRIAL
The open-label, single-arm, within-subject crossover study is being conducted in patients diagnosed with refractory or recurrent ascites caused due to liver cirrhosis.
It is being carried out in nearly 20 centres in Canada and the US.
The findings, obtained from 40 participants implanted with the alfapump system in the Pivotal Cohort, showed that all the study’s primary effectiveness endpoints were achieved.
The trial found that participants had a 100% median per-patient reduction in the frequency of therapeutic paracentesis (TP) after implantation compared to pre-implantation.
Nearly 77% of patients had at least a 50% TP reduction after implantation compared to pre-implantation.
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.
SWANSEA UNIVERSITY DEVELOPS DIAGNOSTIC TOOL TO DELIVER QUICK HEALTH TEST RESULTS
Researchers at Swansea University have developed a new diagnostic tool as a proof of concept (PoC) to provide health test results in two minutes.
The new tool leverages artificial intelligence (AI) to accelerate the identification of biomarkers in biofluids, including blood plasma, synovial fluid, and saliva-containing proteins to diagnose many health conditions.
The scientists believe that the test will help deliver quick test results for health conditions, including Alzheimer’s, cardiovascular disorders, and joint quality.
GENETIKA+ OBTAINS CE-IVD MARK FOR NEUROKAIRE BLOOD TEST
Personalised medicine solutions developer Genetika+ has obtained a CE-IVD mark for its new blood test, NeuroKaire, to optimise treatment for depression.
The new AI-powered tool is intended to help physicians determine the optimal antidepressant treatment required for major depressive disorder (MDD) patients.
The company stated that the test had been developed following training on data collected from patients with MDD.
The data collected brings together microscopy, sequencing as well as clinical data by leveraging advanced AI and machine learning approaches.
OLLEYES TO INTEGRATE TOBII’S EYE-TRACKING FEATURE IN VISUALL ETS DEVICE
Medical software firm Olleyes has announced a collaboration to integrate Tobii’s advanced eye-tracking features in its VisuALL ETS model.
The VisuALL is a VR visual field perimeter which has been designed for the standardised and mobile evaluation of the visual field.
It automatically analyses the retinal sensitivity in Glaucoma patients and in those with other visual disorders.
SQI DIAGNOSTICS’ RALI-DX TEST SECURES HEALTH CANADA AUTHORISATION
SQI Diagnostics’ Rapid Acute Lung Injury Diagnostic (RALI-Dx) IL-6 Severity Triage Test has secured Interim Order (IO) authorisation from Health Canada.
With less than an hour of turnaround time, RALI-Dx is expected to address a key public health need.
According to the company, RALI-Dx is the first interleukin-6 (IL-6) diagnostic test authorised in Canada.
The test will focus on assessing Covid-19 patient risk by testing for the presence of bio-marker IL-6.