Siemens Healthineers received Emergency Use Authorization for CLINITEST® Rapid COVID-19 Antigen Self-Test by the FDA
On December 29, 2021, Siemens Healthineers was granted Emergency Use Authorization (EUA) for its CLINITEST Rapid COVID-19 Antigen Self-Test by the United States Food and Drug Administration (FDA) for individuals age 14 and older or adult-collected samples from individual’s ages 2 to 13 years. The test is an easy-to-use nasal swab test intended to assist the rapid detection of SARS-CoV-2 by providing visually read results in just 15 minutes. From the starting of January 2022, the test is expected to be available nationwide through retail distribution.
Christoph Pedain, Ph.D., Head of Point of Care Diagnostics, Siemens Healthineers said that undetected COVID-19 exposure is a significant driver of community spread. With the CLINITEST Rapid COVID-19 Antigen Self-Test, consumers will be able to do a fast, reliable, and convenient test to proffer additional safety. Siemens Healthineers is proud to bring this high-quality test, already utilised and trusted by families, medical professionals, businesses, and governments in several parts of the world, to the United States under FDA Emergency Use Authorization.
The CLINITEST Rapid COVID-19 Antigen Self-Test has been clinically assessed in a study designed specifically for the US market. It is highly accurate with a specificity of 99.3% (95% CI: 95.9 to 100.0%) and with a sensitivity of 86.5% (95% CI: 79.6 to 91.3%) when compared to the nucleic acid PCR test method.
According to DelveInsight’s “In Vitro Diagnostics Market & Competitive Landscape”, the COVID-19 pandemic led to the surge in revenue for the in vitro diagnostics market and several self-monitoring and testing kits and products. Due to the contagious nature of the COVID-19 virus, there was a huge need for diagnostic methods to devise strategies for the containment of the viral spread. With the isolation and the identification of the genomic sequence of the COVID-19 strain, a plethora of COVID-19 test kits made it to the market to offer to the different requirements of patients and healthcare workers.
Paragon 28, Inc. received FDA Clearance for R3ACT™ Stabilization System
On December 29, 2021, Paragon 28, Inc. (“PARAGON”), a medical device company primarily focused on the foot and ankle orthopedic market, received the 501(k) marketing clearance for its R3ACT™ Stabilization System by the United States FDA. The system is expected to be commercially launched in early 2022. The inclusion of the system bolsters the company’s comprehensive ankle fracture and soft tissue portfolio.
Albert DaCosta, Paragon 28 Chief Executive Officer, and Co-Founder commented that Syndesmotic stabilization has been a journey to comprehend and to replicate. They are excited to have developed a product, which they believe addresses the complex needs of this indication and mimics not only the dynamic environment of the syndesmosis but also transitions the function of stabilization to best match the healing phases of the soft tissues.
According to DelveInsight’s Foot and Ankle Devices Market & Competitive Landscape, the global Foot and Ankle Devices Market was worth USD 5.52 billion in 2020, growing at a CAGR of 7.66% during the study period from 2021 to 2026 to touch USD 8.58 billion by 2026. The factors such as the growing need for the prevalence of the bone-related disorder, an increasing number of diabetes-related complications, rising geriatric population, a growing number of accident and trauma cases, and the increasing number of sports-related injuries, and the growing focus on developing technologically advanced devices are anticipated to drive the foot and ankle devices market.
Pulnovo Medical declared positive results from PADN-CFDA pivotal trial for the Pulmonary Arterial Hypertension treatment
On January 01, 2022, Pulnovo Medical Limited, a globally recognized medical device company focused on developing a treatment for cardiopulmonary disease, declared the positive results from the Pulmonary Artery Denervation (PADN)-CFDA pivotal study. It became the first global completed pulmonary hypertension treatment device RCT study and met the primary efficacy and safety endpoints.
PADN is an innovative radiofrequency ablation device for treating Pulmonary Arterial Hypertension (PAH). With the radiofrequency ablation technology, the device blocks the pulmonary intima sympathetic nerve and reduces pulmonary artery pressure to delay disease progression. In the year 2018, it was recognized as CFDA innovative medical and was designated as a “breakthrough device” by the US FDA in the year 2021.
Dr. Gregg W. Stone, TCT Conference Chairman and one of the world’s leading cardiovascular experts announced in the Transcatheter Cardiovascular Therapeutics Conference held in 2021, that he will lead a group of global pulmonary hypertension and cardiovascular experts to launch a pivotal trial in 2022, being the first global PADN multicentre pivotal trial.
According to DelveInsight’s “Pulmonary Arterial Hypertension (PAH) Market“, the Pulmonary Arterial Hypertension prevalent cases were 71,816 in 7MM (the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan) in 2020. Pulmonary Arterial Hypertension is a progressive disease of the lung vascular system, primarily affecting the small pulmonary arterioles.
Abbott offers Proclaim™ XR Spinal Cord Stimulation System with expanded MRI Compatibility in the US
On January 04, 2022, Abbott received the US FDA approval for new expanded magnetic resonance imaging (MRI) compatibility for its Proclaim™ XR Spinal Cord Stimulation (SCS) System with Octrode™ leads. The new FDA-approved labeling lifts the MRI restrictions on 60-centimeter Octrode™ leads, which are electrically insulated wires implanted to transmit electrical impulses to the target nerves. The expanded MRI compatibility would allow patients with a Proclaim XR SCS device to obtain higher-quality images with necessary MRI scans.
Under the expanded labeling, octrode lead tips can be placed anywhere they are required along the spine and still be considered MRI conditional. In addition, the patients with the Proclaim XR SCS device will now need to wait 30 minutes between scan cycles of 30 minutes. Also, the radiofrequency energy no longer needs to be limited with Proclaim SCS and Octrode devices as long as the MRI is in the normal operating mode.
Allen W. Burton, M.D., medical director of Abbott’s neuromodulation business, said that MRIs have increasingly become a vital tool helping doctors diagnose an illness or injury. They are particularly vital for patients who have certain comorbidities, such as cancer or multiple sclerosis. They made it their mission to secure expanded MRI labeling for their spinal cord stimulation devices both those that were already implanted and those still to be implanted for the sake of the patients and their doctors.
According to Spinal Cord Stimulators (SCS) Market & Competitive Landscape“, the global Spinal Cord Stimulators Market was worth USD 2.08 billion in 2020, increasing at a CAGR of 8.69% during the study period from 2021 to 2026 to touch USD 3.42 billion by 2026. The need for Spinal Cord Stimulators is due to the rising number of chronic pain patients, and neuropathic pain in the shoulder, legs, and knee. The technologically advanced devices that are non-invasive, remove targeted pains, cause a decrease in patient discomfort, with no side effects, are likely responsible for a boost in the Global Spinal Cord Stimulators Market growth. In addition to that, favorable government regulations for commercialization and launching products in the market and increasing geriatric population are some of the factors responsible for propelling the Spinal Cord Stimulators Market growth.
RTI Surgical declares spin-off of its businesses into two independent companies
On January 04, 2022, RTI Surgical, a global private company, declared that the company will spin off its Metals business, creating two independent companies that are focused on the needs of customers and patients in their distinct market segments. Montagu, a leading equity firm will retain the ownership of both the companies. As a result of the spin-off, the metal business responsible for covering design, development, manufacturing, and regulatory support of metal and polymer implants and instruments used in orthopedics, spine, and cardiothoracic applications will convert its name and market brand to Resolve Surgical Technologies whereas the Tissues & Biologics business comprehensive portfolio of tissue-based surgical implants across multiple market segments will retain RTI Surgical name.
Megan Osorio, current President of the Metals business, will become CEO of Resolve Surgical Technologies said that their hallmark has been innovative product development, world-class manufacturing, rigorous quality management, and regulatory expertise. Their new brand carries this equity forward and communicates their exciting direction as an independent company.
Olivier Visa, the CEO, said that the team is passionate about partnering with their customers to develop and deliver solutions that restore quality of life for patients while maximizing the gift of tissue donation. With RTI Surgical’s singular focus on allograft and xenograft tissue-based implants, their team will offer expanded private label solutions for customers. Their expertise comprises design, development, and processing in addition to all aspects of product life cycle management, regulatory compliance, and Design History File ownership.
According to DelveInsights, “Spinal Fusion Devices Market & Competitive Landscape”, the global Spinal Fusion Devices Market was worth at USD 6.21 billion in 2020, increasing at a CAGR of 4.57% during the study period from 2021 to 2026 to touch USD 8.08 billion by 2026. The need for demand for Spinal Fusion Devices is due to the increasing spinal disorders prevalence among the growing old-age population globally; increase in demand for minimally invasive surgeries. Moreover, technological advancement in the product line, and new product launches among others are also anticipated to drive the global spinal fusion market.
Endotronix receives FDA approval for PROACTIVE-HF pivotal trial design change to single-arm study
On January 05, 2022, Endotronix, Inc., a medical technology company dedicated to advancing the treatment of heart failure (HF), received FDA approval for an amendment to the company’s PROACTIVE-HF study, a pivotal Investigational Device Exemption (IDE) trial investigating the Cordella Pulmonary Artery (PA) Pressure Sensor, shifting it to a single-arm study from a randomized control study. The new trial design ensures that over 100 previously enrolled patients have immediate access to the proven clinical benefits of PA pressure-guided therapy. Currently, the company is implementing the updated study design at trial sites worldwide.
Dr. Liviu Klein, Section Chief, Advanced Heart Failure, Mechanical Circulatory Support, Pulmonary Hypertension, and Heart Transplant at UCSF and National Principal Investigator of the PROACTIVE-HF trial commented that the FDA’s decision to approve the amended study design further confirms what they are seeing in clinical practice. PA pressure-guided heart failure management is soon becoming the standard of care for NYHA class III patients based on the growing body of evidence supporting this approach. Comprehending changes in PA pressure data is key to properly implementing guideline-directed medical therapy and keeping these patients out of the hospital. The Cordella HF System and Sensor proffers the next-gen technology in PA pressure sensing and will play an important part in how heart failure patients are managed moving forward.
Harry Rowland, CEO of Endotronix, said that the FDA’s decision is great news for their PROACTIVE-HF study patients; they now have immediate access to technology that is designed to keep them healthier and out of the hospital. Moreover, it is a vital acknowledgment for the therapeutic category and the benefits that PA pressure-guided heart failure management enables. Their team and clinical partners have been energized by the announcement and it obviously has a significant impact on their ability to bring the Cordella Sensor to market sooner in the US and Europe.
The Cordella System, without the sensor, is commercially available for use in the US and E.U. and is currently in cardiology centers across the US. Whereas the Cordella PA Sensor is currently under clinical investigation in Europe (SIRONA II CE Mark Trial) and in the US (PROACTIVE-HF IDE Trial) and is not currently available for commercial use in any geography.
According to DelveInsights, “Congestive Heart Failure Treatment Devices Market & Competitive Landscape”, about 6.2 million adults in the US had heart failure in the year 2020.