Zsquare ENT-Flex™ Rhinolaryngoscope, the First High-Performance Single-Use ENT Endoscope of Zsquare received FDA Clearance

On July 06, 2022, Zsquare, one of the leading developers of high-performance, single-use endoscopes, received Food and Drug Administration 510K clearance to market its first product, the Zsquare ENT-Flex™ Rhinolaryngoscope. The product will be available in United States hospitals and for physicians only. 

The Zsquare ENT-FlexTM is the first single-use endoscope with a hybrid design in which an all-optical disposable shell completely covers a reusable imaging core. The endoscope has the smallest diameter of the endoscope shaft. This improved design provides health practitioners with excellent quality imaging at the lowest cost-per-use in single-use endoscopy. This is a one-of-a-kind engineering technology that offers multiple advantages, including increased patient comfort, greater diagnostic quality, and considerable cost savings for providers and payers. Thus, the size and image quality of this first-to-market Zsquare product offers greater accessibility in endoscopic procedures.

The Zsquare ENT-FlexTM Rhinolaryngoscope is recommended for use in diagnostic ENT procedures performed through the nose and throat, and it is the only scalable platform capable of delivering high-resolution pictures in flexible, single-use endoscopes.

“As the world continues to confront cross-contamination risks, Zsquare has collaborated closely with clinicians and regulatory authorities to pioneer innovative technologies with ground-breaking patient-care capabilities to advance the endoscopy industry’s shift to single-use devices.” Said Asaf Shahmoon, CEO and Co-Founder of Zsquare. Asaf Shahmoon also added, “This is a significant milestone and delivers on our pledge to transform the endoscopy market, setting a new standard for single-use endoscopes,”

The Zsquare ENT-Flex™ Rhinolaryngoscope is the first single-use endoscope to show superior capabilities than reusable scopes with the same diameter – from superior image quality to a smaller outer diameter,” said Professor Hisao Tajiri, M.D., senior advisor, Japan Gastroenterological Endoscopy Society (JGES) and member of the Zsquare Scientific Advisory Board. He also added, “This groundbreaking FDA approval to market opens the door to an industry shift toward affordable, high-performance hybrid single-use endoscopes in other indications of use.”

Additionally, according to DelveInsight’s “Endoscopes Market” report, the global endoscopes market was valued at USD 12.95 billion in 2021, growing at a CAGR of 6.05% during the forecast period from 2022 to 2027 to reach USD 18.32 billion by 2027. The rise in demand for endoscopes is predominantly attributed due to the increasing prevalence of chronic diseases such as irritable bowel syndrome (IBD), gastroesophageal reflux disease (GERD), peptic ulcers, and others that require the use of endoscopes for diagnostic purposes. Moreover, the surge in the burden of the geriatric population across the globe will increase the demand for endoscopes. As per the Delveinsight analysis, North America is expected to have a significant share of revenue in the overall endoscopes market during the forecast period. This is due to the factors such as the increasing prevalence of cancers and chronic disorders in the region. Moreover, the improving healthcare expenditure and high geriatric population in the region are expected to aid in the growth of the North American endoscopes market. 

ClearMind Biomedical Announced the Completion of First in Man Clinical Trial for Least Invasive ICH Treatment 

On July 8, 2022, ClearMind Biomedical, one of the leaders in the medical device industry, completed its First in Man (FIM) clinical trial in Taiwan for a neurosurgical endoscope, the Axonpen System. The trail was completed with exceptional results. 

The Axonpen System is the most integrated minimally invasive neurosurgical tool, combining over eight key features including tissue visualization, a debrider, and a flexible tip. The system is the least invasive treatment for intracerebral hemorrhage (ICH). The device requires only a 6.5mm channel to access the intracranial space. 

During the trial, all 10 participants demonstrated speedier recovery times, spending just an average of three days in the intensive care unit. This is more than a 50% reduction in time when compared with the 10 to 14 days needed for recovery from traditional treatment methods. Patients demonstrated a full recovery of motor skills in most cases. Furthermore, post-treatment ICH blood remnants were below 15ml across the cohort. For a better prognosis, a minimum of 70% or more of the hemorrhage should be removed, with no more than 15ml of blood remnants at the injury site. Every additional 1ml of clotted blood removed enhances the chances of a good recovery by 10%.

“We set out to develop a fully integrated neurosurgical endoscope that is not only safe with minimal downtime but also optimal with every function needed by neurologists performing the procedure, which our trial has proven. While achieving this, we remain compliant with international regulations and standards to meet the needs of medical practitioners and ensure patients’ safety during treatment,” said Carrey Yang, CEO of ClearMind Biomedical.

According to the DelveInsight analysis, the Gastroendoscopes Market is anticipated to grow at a significant rate during the forecast period (2022-2027). This is owing to an increase in the prevalence of gastrointestinal diseases and cancers, globally. For instance, as per the World Health Organisation (WHO) 2020, stomach cancer was the fifth most common cancer worldwide. The increasing prevalence of cancer will increase the demand for gastroendoscopes in the market as these devices are used in the diagnosis and treatment of cancers, thereby increasing the overall market growth of gastroendoscopes devices during the forecast period from 2022 – 2027.

Bruker Launched NMR-based Molecular Phenomics Clinical Research Tool for ‘Long COVID’ Multi-Organ Risk Assessment

On July 6, 2022, Bruker Corporation, an American manufacturer of scientific instruments for molecular and materials research, launched PhenoRisk PACS™ RuO, a research-use-only NMR test for molecular phenomics research on Long COVID patients’ blood samples. 

The PhenoRisk PACSTM RuO test is promising for early-stage risk factor research, long-term recovery monitoring, and possible secondary organ damage in cardiovascular disease, type II diabetes, renal failure, and inflammation. It consists of an AvanceTM IVDr NMR spectroscopy system that tests several biological mechanisms of action at the same time in a 20-minute blood test from SARS-CoV-2 acute infection survivors who have long-term sequelae known as Post-Acute COVID Syndrome (PACS) or commonly known as Long COVID syndrome. 

Even in asymptomatic acute COVID patients, the PhenoRisk PACSTM RuO test defines metabolic and proteomic indicators of SARS-CoV-2 pathobiology, enabling multi-organ risk assessment, recovery, and therapeutic investigation in different Long COVID dysfunctions. 

This new NMR test has the potential to quantitatively distinguish PACS patients from healthy or fully recovered individuals by investigating COVID-triggered pheno-conversion, which is defined as a transient or persistent systemic change of molecular signatures in human plasma samples following acute infection. PACS recovery may be indicated by subsequent pheno-reversion of metabolic profiles observed by PhenoRisk PACSTM RuO.

Moreover, PhenoRisk PACSTM RuO measures composite signals for glycoprotein and phospholipid groups, which can indicate inflammation and cardiovascular disease risk, as well as Supramolecular Phospholipid Composite, a novel NMR biomarker (SPC). These indicators distinguish COVID-19 from controls well, and the Glyc/SPC ratio has been proposed as a viable molecular marker for Long COVID, which might considerably supplement existing clinical and therapeutic studies.

Dr. Oscar Millet, leader of the Precision Medicine and Metabolism group at CIC bioGUNE in Bilbao, Spain, said, “PhenoRisk PACS™ RuO is an automated, easy to use, and standardized approach to investigate the complex metabolomic signatures induced by SARS-CoV-2. It enables clinical research on the screening and monitoring of long-term sequelae after acute COVID-19, in patients with Long COVID syndrome, and even in asymptomatic subjects – a breakthrough in understanding PACS.”

Dr. Iris Mangelschots, President of Bruker BioSpin’s Applied, Industrial, and Clinical Division, said, “We are very excited to provide this multi-organ PACS risk screen to the clinical and pharmaceutical research community, after the preliminary validation by our partners in the International COVID-19 Research Network. We believe that PhenoRisk PACS™ RuO could make a significant contribution in research to combat the effects of Long COVID.”

According to DelveInsight’s Rapid Diagnostic Kits Market” report, the global rapid diagnostic kits market was valued at USD 14.12 billion in 2021, growing at a CAGR of 3.55% during the forecast period from 2022 to 2027 to reach USD 17.38 billion by 2027. The rapid diagnostics kits market is slated to witness prosperity owing to factors such as the rising prevalence of chronic disorders such as diabetes globally. Moreover, the increasing prevalence of COVID-19, increasing incidence of Human Immunodeficiency Virus (HIV), and the increased regulatory approval of rapid diagnostics in the market across the globe are anticipated to propel the overall market growth of the rapid diagnostic kits market. Furthermore, as per the Delveinsight analysis, among all regions, North America is estimated to hold the highest share in the global rapid diagnostic kits market owing to the rising prevalence of HIV infections in the region along with an increase in healthcare spending in the region. 

EarlySign Signed Strategic Collaboration Agreement with Roche on Artificial Intelligence Solution for Lung Cancer Early Detection 

On July 7, 2022, Medial EarlySign, a pioneering company developing Artificial Intelligence (AI) based clinical predictive analytics, announced the signing of a new partnership with Roche, which will focus on innovative, evidence-based solutions for the early detection of lung cancer

The objective of this new joint endeavor is to offer proven clinical machine learning models to enhance lung cancer detection, perhaps leading to earlier diagnosis and treatment. By detecting lung cancer at an earlier stage, it is more likely to be cured. Also, early identification of high-risk patients has the potential to enhance survival rates. 

EarlySign’s LungFlagTM is designed to help providers focus additional effort on enriched subpopulations flagged by LungFlag and determine care pathways so that follow-up screenings can be more precisely prescribed cost-effectively by using proven, highly accurate models based on a variety of signals including basic demographic, medical, drug, and routine clinical laboratory data. 

This new arrangement expands on an existing relationship between Roche Diagnostics and EarlySign, which was originally centered on a tailored health solution for the early identification of stomach cancer. The collaboration, which is designed to bring new clinical machine learning solutions to the global market, demonstrates the parties’ desire to transform healthcare delivery through digital solutions with smart algorithms that allow personalized preventive care to improve patient outcomes while making care more affordable and sustainable.

“As the only company combining pharma and diagnostics solutions, as well as cutting-edge tech and data capabilities under one roof, we are working towards a future in which treatments are targeted to an individual’s needs” commented James Sabry, Head of Roche Pharma Partnering. He added, “To achieve this goal, we are eager to team up with innovative partners like EarlySign, who share our vision to enable better decision-making and ultimately improve patient outcomes.”

Ori Geva, CEO, and co-founder of EarlySign commented, “Our ongoing partnership with Roche’s Diagnostics and now also the Pharmaceuticals division helps accelerate the development and deployment of transformational technologies that create new opportunities to ease the burden of serious disease for people throughout the world.” Ori Geva, added, “Our partnership with Roche continues to put patients first by seeking better ways to prevent, diagnose and treat diseases. Our proven machine learning infrastructure and modeling capabilities provide vital insights that create clinical efficiencies allowing for more precise and personalized care.” 

According to DelveInsight’sCancer Diagnostic Market” report, the global cancer diagnostic market is expected to grow at a 9.43% CAGR during the forecast period (2022-2027). The increase in the cancer diagnostic market is predominantly owing to the increasing number of cases of various cancers worldwide. As per DelveInsight analysis, in the product type segment, the reagent and kits are expected to hold a considerable market share in the year 2021. This is due to the wide availability of reagents & kits for detecting cell signaling, cell proliferation and viability, tumor, suppressor gene, bioactive proteins, and others in cancer cells.  

FDA Clearance Received by Renovia for its Leva® Pelvic Health System as first-line treatment for chronic fecal incontinence 

On July 07, 2022, Renovia Inc., a developer of non-surgical, treatments for female pelvic floor disorders and an advocate for women’s health, announced that the U.S. Food and Drug Administration (FDA) has cleared its leva® Pelvic Health System for the first-line treatment of chronic fecal incontinence (FI) in women

The FDA previously approved leva for the treatment of stress, mixed, and mild-to-moderate urine incontinence (UI) in women. The new indication brings first-line, at-home therapy for fecal incontinence (FI), also known as inadvertent bowel leakage, to the nearly 12 million women in the United States who suffer from the debilitating and degenerative disorder.

The Leva Pelvic Health System offers a novel, non-invasive, medication-free way for women to train and strengthen their pelvic floor muscles—at home in just five minutes a day—to treat urinary incontinence (UI) and chronic fecal incontinence (FI). 

The Leva System is intended to cure FI by assisting women in strengthening their pelvic floor muscles, particularly the puborectalis muscle, which acts as a sling over the rectum and vagina and contributes directly to faecal continence. Leva is a prescription digital therapy (PDT) that helps women exercise their pelvic floor muscles (PFMT). Combining a tiny vaginal motion sensor with a smartphone app, leva offers a straightforward, non-invasive, drug-free solution for women to do PFMT to relieve FI symptoms. Leva takes only five minutes of training every day, which ladies may undertake at their leisure at home.

“We’re gratified that the FDA has cleared this new indication for the leva Pelvic Health System as we now have a tremendous opportunity to treat a condition that’s been cloaked in silence for too long.,” said Renovia’s CEO Eileen Maus. He added, “Leva’s popularity among women with urinary incontinence already made it a great choice for providers, particularly OB/GYNs, who are at the frontlines of women’s care. Leva enables discreet, at-home, non-surgical, drug-free symptom relief, which we believe positions it to dramatically improve women’s access to improved first-line care.”

According to DelveInsight’sUrinary Incontinence Devices Market” report, the global urinary incontinence devices market is expected to grow at a 6.36% CAGR during the forecast period (2022-2027). The increase in urinary incontinence devices is predominantly owing to the increasing number of cases of urinary incontinence worldwide. Additionally, as per DelveInsight analysis, in the region segment, North America is expected to hold a considerable market share in the year 2021. This is due to the rising prevalence of urinary incontinence and urological conditions among both men and women, which will increase the demand for urinary incontinence devices, thereby anticipated to increase the urinary incontinence devices market in North America in the forecast period of 2022 – 2027. 

NeuroOne Medical Technologies Corporation Announced First Clinical Case Using Evo® sEEG Electrode 

On July 12, 2022, NeuroOne Medical Technologies Corporation, a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, announced the first clinical case using the Evo sEEG electrode for intraoperative brain mapping at the subsurface level of the brain. 

In comparison to cortical electrodes, sEEG electrodes provide a comparable function at the subsurface level of the brain utilizing a far less invasive procedure that does not necessitate the removal of the patient’s top section of the skull. Because of its less intrusive installation and subsurface location, sEEG has been the most often utilized technique in these treatments.

Dave Rosa, Chief Executive Officer of NeuroOne, commented, “This first clinical case use represents a major milestone achievement of one of our primary objectives for the Company. We are grateful to Dr. Gross and his staff and were excited to hear of the positive experience he had using the electrode. We look forward to continuing to gain clinical experience with the electrode as we prepare to submit a special 510(k) to FDA in August for clearance to commercialize the product for less than 30 days of use.”According to DelveInsight’s Brain Monitoring Devices Market” report, the global brain monitoring devices market is expected to grow at a 7.27% CAGR during the forecast period (2022-2027). The increase in brain monitoring devices is predominantly owing to the increasing number of cases of neurological diseases worldwide. Additionally, as per DelveInsight analysis, in the product type segment, EEG devices are expected to hold a considerable market share in the year 2021. This is due to the wide application circle in the detection of neurological disorders such as epilepsy, seizure, Alzheimer’s, and other disorders.