Hisashi Tachizaki, Vice President and General Manager of the CT Systems Division at Canon Medical Systems Corporation, said they had taken the Aquilion ONE / PRISM Edition to the next level of deep intelligence with PIQE. Canon Medical proceeds pushing what is possible using AI. With PIQE, they can further reveal essential diagnostic information for cardiac CT scans, and SilverBeam enables ultra-low-dose CT lung cancer screening.
LensGen® obtains IDE approval from the US FDA to begin the clinical study of the Juvene® Presbyopia-correcting Intraocular Lens
On November 29, 2021, the US Food and Drug Administration (FDA) granted an Investigational Device Exemption (IDE) to initiate a pivotal study of the LensGen, Inc.’s Juvene intraocular lens (IOL) for cataracts patients.
The company has designed Juvene IOL to permanently restore clear and continuous vision at all distances, including near and intermediate. It is modular and has a fluid optic component, which changes shape to adjust focus on requirement for today’s active lifestyles. The lens is implanted using the same surgical techniques used with traditional intraocular lenses.
Ramgopal Rao, LensGen Chief Executive Officer, said that they are proud to achieve this significant milestone for the company enabling them to proceed further with the IDE pivotal trial with the main goal of receiving premarket approval in the largest eye care market in the world.
Eric Donnenfeld, M.D., Clinical Professor in the Department of Ophthalmology at the New York University Grossman School of Medicine and Founding Partner of Ophthalmic Consultants of Long Island added that based on the Grail Study clinical data and the direct experience with surgery and observations of the patients implanted with Juvene IOL, LensGen technology has the potential to offer a tremendous new and superior option to their patients.
According to DelveInsight’s Intraocular Lens Market & Competitive Landscape, the global Intraocular Lens Market is USD 3,687.20 million in 2020 that is increasing at a CAGR of 4.88% during the forecast period from 2021 to 2026 to touch USD 4,812.32 million by 2026. The need for intraocular lenses is observing a growth because of the rising eye diseases prevalence, rising initiatives by various governments globally in controlling and treating blindness, technological advancements in IOLs, and the rising geriatric population.
Hyperfine receives FDA clearance for deep learning portable MRI and launches the life-saving diagnostics
On November 29, 2021, Hyperfine, Inc., developer of the first FDA-cleared portable magnetic resonance imaging (MRI) device, Swoop®, declared the FDA 510(k) clearance and launch of its new advanced image reconstruction technology utilising deep learning (DL). The image quality resulting from this innovative approach elevates the diagnostic value of portable MRI.
According to DelveInsight’s “Magnetic Resonance Imaging Devices Market & Competitive”, there is a limitation with the current MRI systems because of their size, fixed location, cost, and staff training requirements. Hyperfine will aid in overcoming these limitations by reconsidering MRI design from the bottom up and adding smart computing. The launch of Swoop® will bring the necessary changes in the market as it is an easy-to-use, portable, and affordable system costing cheaper than the annual service contract of many conventional MRI systems.
Dave Scott, president and chief executive officer of Hyperfine, said that enhanced image quality via artificial intelligence, paired with the decreased cost and more capabilities of Swoop, is allowing more access to high-quality MR imaging for patients, irrespective of income, resources or location.
In January 2021, Hyperfine obtained FDA clearance for its advanced artificial intelligence (AI) application, which gauges brain structure and pathology in images taken overby Swoop through tools featuring automatic measurement of ventricular volume, brain extraction, brain alignment, and midline shift and can be utilised by clinicians to diagnose and measure acute neurological conditions at a patient’s bedside.
Nevro announces three important clinical data publications for treating Painful Diabetic Neuropathy with 10 kHz therapy
On November 29, 2021, Nevro Corp., a global medical device company, which is providing innovative, evidence-based solutions for the chronic pain treatment, declared three vital clinical data publications for Painful Diabetic Neuropathy (PDN) treatment with 10 kHz Therapy, comprising 12-month data from the landmark SENZA-PDN Randomized Controlled Trial (RCT) published online in Diabetes Care, and real-world evidence and a comparative literature review of high vs. low-frequency SCS evidence, both published in the Journal of Diabetes Science and Technology.
The observations from all three studies throw light on the tremendous advantages of HFX™ for PDN in clinical and real-world settings. HFX for PDN is the only spinal cord stimulation (SCS) system that is approved by the US Food and Drug Administration with a particular on-label indication for PDN treatment.
D. Keith Grossman, Chairman, Chief Executive Officer and President of Nevro, said that these three vital clinical data publications further extend the growing body of positive clinical evidence bolstering the use of 10 kHz Therapy in treating PDN patients and persist to showcase the safety, durability, and consistency of pain relief and other results that can be achieved with HFX for PDN in both clinical and real-world settings. No conventional, low-frequency SCS treatments have shown such positive results in treating Painful Diabetic Neuropathy patients.
Dr. Erika Petersen, Professor of Neurosurgery, Director of Functional and Restorative Neurosurgery at the University of Arkansas for Medical Sciences, and lead investigator of the SENZA-PDN study, added that painful diabetic neuropathy patients have no way to cure their condition, and many have difficulty achieving relief from their pain. However, with high-frequency 10 kHz Therapy, they observe durable pain relief and potentially disease-modifying neurological improvements.
According to DelveInsight’s “Chronic Pain Associated with Painful Diabetic Neuropathy Market”, the highest contribution in the market size was the pharmacotherapy market with 95.2%, while the medical device market takes up only 4.8% in 2018, which is expected to increase by 2026 with the launch of new devices and increased awareness.
According to DelveInsight’s estimates, the total prevalent cases of selected indications for Chronic Pain associated with Painful Diabetic Neuropathy were 7,670,318 cases in the 7MM in 2018 and are expected to increase by 2030. The US accounted for the highest cases, with 3,782,136 cases in the same year.
FDA clears SeptiCyte® RAPID – the First One-Hour, direct-from-Blood Sepsis Test
On November 30, 2021, Immunexpress, Inc., a molecular diagnostic company dedicated to improving outcomes for suspected sepsis patients, announced that SeptiCyte® RAPID has received 510(k) clearance from the US Food and Drug Administration (FDA). The cleared test will help in distinguishing sepsis from infection-negative systemic inflammation in hospitalized patients suspected of sepsis.
Roy Davis, M.D., PhD, Chief Medical Officer of Immunexpress, said that SeptiCyte® RAPID has the potential to transform sepsis diagnosis, addressing a critically unmet requirement in the ICU. SeptiCyte® RAPID has been assessed in hospitals since 2019. Major hospital systems with which they have worked are anxiously waiting to incorporate this into the current diagnostic toolset, allowing clinicians to make swift and accurate clinical decisions.
Rollie Carlson, Ph.D., Chief Executive Officer of Immunexpress, added that it has been a long journey to transfer their clinically proven novel biomarker technology from their 8-hour FDA-cleared SeptiCyte® LAB product in 2017, to the advanced 1 hour sample-to-answer Biocartis Idylla™ testing platform.
According to DelveInsight’s Sepsis Market, in 2020, the total estimated Incident Cases of Sepsis were 3,400,940 cases in the 7MM, which is expected to increase in the forecast period (2021-2030). The United States was the major contributor (55.01%, in 2020) to the incident population of Sepsis in the 7MM, with 1,870,897 cases.
DelveInsight estimates the market size of Sepsis in the 7MM was estimated to be USD 2,548 million in 2020.
GE Healthcare unveils new AI and Digital Technologies and Solutions to help solve healthcare’s most pressing problems
On November 28, 2021, GE Healthcare revealed around 60 innovative technology solutions covering the healthcare spectrum comprising patient screening, diagnostics, therapy planning, guidance, and monitoring at the Radiological Society of North America’s (RSNA) 2021 Annual Meeting. The company has been developing innovations supported by artificial intelligence (AI) and digital solutions to transform healthcare delivery, making it easier and more efficient for clinicians and health systems and more personalised and precise for patients during the ongoing global pandemic.
Pandemic has created an urgent need for technology and solutions that aid clinicians manage seriously ill COVID-19 patients, advanced diseases such as cancer and heart disease, a backlog in non-urgent care, and an ageing population while battling burnout and workforce shortages.
The company developed innovative AI-powered, automated, and data-driven solutions to support diagnostic confidence, ease the burden of care and enhance workflow for healthcare systems around the world: SIGNA Hero, SIGNA Artist Evo, Revolution Apex platform, Allia Platform, AMX Navigate, Critical Care Suite 2.0, Vscan Air, Enterprise Imaging in the Cloud, Digital Expert Access, and ulrichINJECT CT Motion.The company is working with industry leaders, such as SOPHiA GENETICS, to bring integrated cancer care by garnering insights across various diagnostic modalities to better target and match treatments to each patient’s cancer type aiding to ensure more effective and personalised treatment. Through the Zionexa acquisition, the company is advancing precision diagnostics and affecting clinical care by commercialising innovative molecular imaging agents.
