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Abbott Receives Regulatory Approval from US FDA for Alinity™ m STI Assay
On May 04, 2022, the US Food and Drug Administration (FDA) granted the regulatory approval to Alinity™ m STI Assay developed by Abbott which is capable of simultaneously detecting and differentiating four common sexually transmitted infections (STIs).
It is a first-of-its-kind multiplex test that will help address increasing STI rates which were attributed to the disruptions in delivery of care during the pandemic contributed that led to a decline in routine STI screening and an increase in cases.
The Alinity m STI test tests for four microorganisms namely Chlamydia trachomatis (CT), Trichomonas vaginalis (TV), Neisseria gonorrhoeae (NG), and Mycoplasma genitalium (MG). The test only requires one swab sample or a urine sample collected in a healthcare setting by either a clinician or by the patient. The test is devised to run on Abbott’s Alinity m system which is most advanced high-volume laboratory molecular equipment offered by Abbott. Alinity m is based on polymerase chain reaction (PCR) technology with high sensitivity in detecting infectious diseases. Being highly accurate and fast, this test can help healthcare providers save time, improve efficiency, and better serve patients.
Kathryn Becker, Ph.D., global director of scientific affairs innovation in Abbott’s diagnostics business mentioned, “This four-plex STI test gives healthcare providers a more holistic picture of someone’s health in a single test, helping to support the best treatment plan to address these common STIs individually or as co-infections.”
As per DelveInsight analysis, the entry of such molecular diagnostic tests into the market further paves the way for timely diagnosis of infectious diseases such as sexually transmitted diseases that have a high transmissibility rate. This would further help in controlling the spread of infection among people as well as administer appropriate treatment to infected individuals. According to DelveInsight’s “In Vitro Diagnostics Market” report, the in-vitro diagnostics market was valued at USD 67.82 billion in 2020, growing at a CAGR of 4.17% during the forecast period from 2021 to 2026, in order to reach USD 86.35 billion by 2026. The in-vitro diagnostics market is estimated to register positive revenue growth owing to the factors such as the rising prevalence of various infectious diseases such as COVID-19, the growing prevalence of various cancers, increasing cases of hematological diseases, and increasing product development activities with respect to in vitro diagnostics among others.
Owen Mumford and Stevanto Group Enter into a Collaboration for Aidaptus Auto-injector Development
On May 04, 2022, Stevanto Group and Owen Mumford Ltd entered into an exclusive collaboration for the development of Aidaptus auto-injector which is originally developed by Owen Mumford.
Aidaptus is a 2-step, single use auto-injector with a versatile design which is capable of accommodating both 1mL and 2.25 mL prefilled glass syringes in the same base device. It also boasts of a plunger sensing technology with a self-adjusting plunger rod that automatically adapts to the individual plunger positions and different fill volumes in each syringe, and does not require any change parts. The auto-injector is also devised to accommodate a unique variety of drug viscosities.
This specific agreement would make Stevanato Group an exclusive manufacturing partner for the device, offering a full set of capabilities to its pharmaceutical customers. As per the agreement, Stevanato Group will mould the components for Aidaptus® and provide final and sub-assembly equipment, while also offering pre-filled syringes to enable pharmaceutical customers to create the final product for patient use. The components will be assembled by both Stevanato Group at its global manufacturing sites and by Owen Mumford at its automated assembly center of excellence in the UK.
The collaboration is intended to bring added value to customers, matching world-class device expertise with premium manufacturing capabilities. It is expected to streamline device production with the aim to and deliver the full value of the innovative Aidaptus® platform to the market.
Adam Mumford, Director of Owen Mumford mentioned, said, “Aidaptus® will help patients to self-administer their individual therapies using a simple and easy to use device.” He further added, “At the same time, this auto-injector can help reduce complexity, minimize supply chain risk and simplify final assembly for pharmaceutical and biotechnology companies, thanks to its ability to adapt to different viscosity, syringe sizes and fill volumes. Often during development or life-cycle management of injectable drug products, changes in these parameters can occur. Now for the first time, the device does not have to be changed as well.”
Mauro Stocchi, Chief Business Officer of Stevanato Group, mentioned, “We believe this agreement is an important step in enhancing and growing the opportunities in our drug delivery systems portfolio as we broaden our capabilities in this key market.”
The collaboration will be jointly launched at Pharmapack 2022.
As per DelveInsight analysis, the entry of such devices would help in better management of indications such as diabetes, allergies, multiple sclerosis among others. Such devices would offer patients a viable option of virtual painless administration of medication, reduced risk of needle stick accidents, and increased patient compliance in terms of helping people with needle phobia. According to DelveInsight’s “Autoinjectors Market” report, the global autoinjectors market was valued at USD 2.17 billion in 2021, growing at a CAGR of 20.65% during the forecast period from 2022 to 2027 to reach USD 6.69 billion by 2027. The demand for autoinjectors is witnessing growth due to the number of indications requiring immediate and emergency administration of interventional drugs such as anaphylaxis and multiple sclerosis, allows for self-administration of drugs, offers a safe alternative to conventional syringes, and the favorable reimbursement programs for these procedures.
Results of First of its Kind Six-Year MiYOSMART Spectacle Lens Follow-up Clinical Study Released by HOYA Vision Care
On May 05, 2022, the Vision Care division of HOYA announced released the results of a six-year follow-up clinical study on MiYOSMART spectacle lens with Defocus Incorporated Multiple Segments (D.I.M.S.) Technology at the Association for Research in Vision and Ophthalmology (ARVO) 2022 conference in Denver, Colorado in the U.S.
The results of the six-year clinical study which was conducted on 90 children in Asia observed the progression of myopia in children who wore the HOYA Vision Care’s MiYOSMART spectacle lens. The results enhanced a previous three-year follow-up study, a continuation of a two-year randomized control trial (RCT), which was published in the British Journal of Ophthalmology, demonstrating strong evidence of the lenses’ effectiveness in slowing down the progression of myopia in children ages 8-13. The findings of the six-year, long-term follow-up study proved the MiYOSMART spectacle lens myopia control effect is sustained over time for children wearing the lens. It also confirmed that patients who stop wearing the MiYOSMART spectacle lens do not show no rebound effects when compared to the initial myopia rates of progression during the two-year randomized control trial or with the general population.
Natalia Vlasak, Global head of Medical and Scientific Affairs at HOYA Vision Care mentioned, “This six-year follow-up clinical study on the MiYOSMART spectacle lens, the longest study conducted on a myopia management spectacle lens ever, shows the myopia control effects are sustainable over time which is very exciting news.” She further added, “This study also answered another key question from eye care professionals which was about the rebound effect of the lens – we are very pleased that this clinical study proves that there is no rebound effect if lens use is stopped.”
The MiYOSMART spectacle lens was launched in 2018.
According to DelveInsight analysis, reporting of such results help further boost the credibility of devices among end-users. As per HOYA Vision Care, since 2018, one million patients in more than 30 countries have benefited from wearing the MiYOSMART spectacle lens. This in turn, is further expected to drive the demand for this product type in coming years. According to DelveInsight’s “Myopia Treatment Devices Market” research report, the global myopia treatment devices market is growing at a CAGR of 7.57% during the forecast period from 2022 to 2027. The increase in demand for myopia treatment devices is predominantly due to the rising prevalence of myopia across the globe. Moreover, an increase in the adoption rate of myopia treatment devices is also expected to bolster the demand for these devices thereby leading to an increased market of myopia treatment devices in the upcoming years. Furthermore, an increase in product launches of various advanced myopia management devices and rising government initiatives to raise awareness among the population regarding myopia treatment are also anticipated to spur the demand for these devices during the forecasted period.
Elekta Announces Launch of a New Radiosurgery System-Elekta Esprit
On May 06, 2022, Elekta announced the launch of Elekta Esprit which is the latest and most advanced system offering by the company in oncology treatment that offers significantly faster-automated treatment planning for clinicians, more personalized and patient-friendly treatments, and a degree of precision able to protect the mind and the person.
The features of Espirit allow the device to offer clinicians superior visualization, as well as remote accessibility and collaboration tools for the treatment team and it provides the accuracy to treat even the most challenging targets while delivering a gentler more personalized approach to radiosurgery. As per the company, the device offers an accuracy of <0.3 mm.
Gustaf Salford, Elekta’s President and CEO, stated, “Esprit will allow clinicians to take radiosurgery to the next level and treat patients with the highest accuracy, protecting their mind and memories and enabling a higher quality of life.”
Verena Schiller, President of Elekta’s Neuroscience Solutions, said, “Esprit was built to address not only today’s clinical needs but is also poised to assimilate future developments that push the boundaries of intracranial radiosurgery treatment.”
Elekta Esprit is pending CE submission and it was unveiled at the European Society for Radiotherapy and Oncology (ESTRO) 2022 on May 6, 2022.
As per DelveInsight analysis, the launch of this device would further help clinicians achieve a more precise and accurate treatment and flexible workflow options based on single session, fractionated, adaptive or staged protocols; in a seamless integrated system design for end-to-end ease of use. Such devices may contribute in improved delivery of treatment to patients ultimately resulting in better prognosis. According to DelveInsight’s “Stereotactic Surgery Devices Market” research report, the global stereotactic surgery devices market is projected to grow at a 5.39% CAGR during the forecast period from 2022 to 2027. The demand for stereotactic surgery devices is primarily witnessing an increase due to the rising incidence of various cancers such as brain cancers, increasing prevalence of movement disorders such as Parkinson’s disease, growing popularity of minimally invasive stereotactic radiosurgery and radiotherapy, and innovation in product development thereby contributing in the growth of the stereotactic surgery devices market during the forecast period from 2022-2027.
US FDA Grants Regulatory Approval to Phillips’ MR 7700 System
On May 09, 2022, Koninklijke Philips N.V. received regulatory approval from the US Food and Drug Administration (FDA) for their new MR 7700 3.0T MR system. This latest break-through MR innovation is designed to deliver unmatched performance and precision for both research and advanced clinical diagnostics, helping to address the Quadruple Aim. The MR 7700 is capable of providing high accuracy to support a confident diagnosis for every patient with Philips’ highest quality diffusion imaging due to the presence of high XP gradients. MR 7700 expands scanning capabilities with a fully integrated multi-nuclei imaging and spectroscopy solution to explore new clinical pathways, without sacrificing clinical imaging workflow or wide-bore patient comfort, to enhance the experience of both staff and patients.
As per the company, the MR 7700 system’s XP gradient coils can achieve up to 35% higher signal-to-noise ratios and up to 35% shorter scan times. Additionally, radiologists achieve 20% more fMRI volumes and 50% more diffusion tensor imaging (DTI) directions in clinical neurology and neuroscience applications.
Additionally, the MR 7700 is equipped with in-built MR protocols to combine proton imaging with imaging based on sodium, carbon, phosphorus, fluorine, and xenon. This multi-nuclei capability makes MR 7700 suitable for enhanced metabolic/functional and anatomical imaging in areas such as pulmonology, neurology, and oncology to help deliver fast, and confident definitive decision-making.
Arjen Radder, General Manager of Magnetic Resonance and Diagnostic X-ray at Philips, said, “Enhanced with ultra-high gradients and artificial intelligence, Philips MR 7700 is built to deliver on the high-quality clinical performance expectations of today, and to facilitate the most demanding and promising research programs that will help drive the future of MR imaging, without sacrificing workflow efficiency or wide-bore patient comfort.”
Philips will spotlight the new system at the upcoming European Congress of Radiology (ECR) annual congress in Vienna in July.
According to DelveInsight’s “Magnetic Resonance Imaging Devices Market” research report, the global magnetic resonance imaging devices market was valued at USD 7.78 billion in 2021, growing at a CAGR of 6.40% during the forecast period from 2022 to 2027 to reach USD 11.29 billion by 2027. The MRI devices market is witnessing a positive growth owing to the factors such as the rising cases of severe chronic diseases like various cancers, cardiac abnormalities, and others, further rapid technological developmental activities, growing geriatric population, rising adoption owing to non-invasiveness, thereby contributing to the growth of the MRI devices market during the forecast period from 2022-2027.
Magneto Thrombectomy Solutions Reports Successful First-in-Human Results for Treatment of Pulmonary Embolism (PE)
On May 10, 2022, Magneto Thrombectomy Solutions focused on developing innovative thrombectomy solutions for the treatment of ischemic stroke and pulmonary embolism, presented successful first-in-human (FIH) results showing the safety and feasibility of the eTrieve™ system. It is a novel catheter-based on electric fields for removing blood clots to be used in patients with acute pulmonary embolism (PE).
The eTrieve™ is a state-of-the-art catheter for performing thrombectomy utilizing the electric properties of blood clots. The device works with the application of electricity wherein when voltage is applied to the catheter, the clot with the negative charge bonds to the positively charged electrode of the catheter, creating a strong grip, and allowing safe removal of the clot.
The prospective, single-arm, multicenter first-in-human study assessed the initial safety and performance of eTrieve™ in treating patients with acute PE. The study enrolled 10 participants across three sites in Denmark and Poland. The results reported the procedure to be safe when performed under only light sedation which also reported no device-related complications. In addition to that, the primary performance endpoint was also met, with a significant reduction of right ventricle to left ventricle volume 48 hours post-intervention. It was also reported that significant clot volumes were removed, and alleviation of PE-associated symptoms was demonstrated. The catheter removed both fresh and organized clots and successfully removed blood clots of various sizes and types and from locations that could not have been accessible via other techniques.
Benny Dilmoney, CEO of Magneto, said, “”Our novel catheter is a groundbreaking solution that can transform treatment of conditions caused by blood clots, such as pulmonary embolism. The technology generates strong attachment forces between the eTrieve™ catheter and the clot, allowing the effective removal of the clot without applying outward radial forces against the vessel wall, minimizing bleeding and enabling removal of both proximal and distal clots. We believe that our novel solution will be a game changer in removing clots and helping people recover safely from life-threatening conditions such as PE. We look forward to initiating our pivotal study on more than 100 patients in multiple medical centers in the US and Europe, planned for later this year.”
Prof. Piotr Musialek, John Paul II Hospital, Krakow, Poland, and an investigator in the study, added, “Magneto provides intermediate and high-risk PE patients with a unique solution for safely and effectively removing large clots blocking the arteries in the lungs.” He further mentioned, “The combination of a large-diameter ‘vacuum cleaner’ with electro-mechanical thrombus extraction, allows an immediate resolution of dyspnea and swift recovery of the cardio-respiratory system.”According to DelveInsight’s “Neurovascular Thrombectomy Devices Market” research report, the global neurovascular thrombectomy devices/neurothrombectomy devices market was valued at USD 722.78 million in 2021, growing at a CAGR of 6.15% during the forecast period from 2022 to 2027 to reach USD 1033.33 million by 2027. The rise in demand for neurovascular thrombectomy devices/neurothrombectomy devices is predominantly imputed to the rising prevalence of neurovascular disorder across the globe which require neurovascular thrombectomy devices/neurothrombectomy devices for their treatment such as ischemic stroke and hemmorhagic stroke, growing burden of old age population. In addition, shifting key players focus towards development of technologically advanced product and initiatives to increase awareness regarding neurovascular diseases and their prevention are some of the factors among others that are likely to upsurge the market for neurovascular thrombectomy devices/neurothrombectomy devices.