Olympus Launched THUNDERBEAT Open Fine Jaw Type X Surgical Energy Device

On September 28, 2022, Olympus Corporation (Olympus), a global MedTech company, announced the release of the THUNDERBEAT™ Open Fine Jaw Type X surgical energy devices for open surgery. The device THUNDERBEAT Open Fine Jaw Type X surgical energy device is designed to support safer procedures. 

The device is already available commercially in Japan. The commercial launch of the product in Europe, the United States, and South Korea is expected in October 2022. 

The THUNDERBEATTM Open Fine Jaw Type X is a single-use hybrid ultrasonic and bipolar electrosurgical instrument designed for open surgery. The device is intended for use in open surgical procedures requiring delicate and fine tissue dissection, such as thyroidectomy or radical neck dissection. The new thermal shield improves the thermal profile on the grasping surface, lowering the risk of heart damage to nearby tissue, nerves, and other structures. The jaw design keeps a finely curved tip for precise dissection and improved visibility while in use.

“This latest addition to our differentiated THUNDERBEAT line of products continues to deliver on Olympus’ commitment to offering hospitals a full portfolio of Advanced Energy devices providing best-in-class functionality for numerous procedures and specialties in minimally invasive and open surgery,” said Phil Roy, Global Vice President and General Manager of the Surgical Devices Business Unit. 

As per DelveInsight’s “Surgical Energy Instruments/Electrosurgical Devices Market” report, the global surgical energy instruments/electrosurgical devices market was valued at USD 8,520.99 million in 2021, growing at a CAGR of 6.64% during the forecast period from 2022 to 2027 to reach USD 12,401.80 million by 2027. The demand for surgical energy instruments/electrosurgical devices is expected to grow owing to the increase in the prevalence of chronic disorders such as cardiovascular disorders, neurological disorders, gynecological disorders, and others, the rising number of surgical procedures, the escalating burden of geriatric patients, and technological advancements in product development and design improvement, thereby contributing in the growth of the surgical energy instruments/electrosurgical devices market during the forecast period from 2022-2027.

Fujifilm Received Regulatory Approval for Latest Generation Endoscopic Ultrasound 

On September 28, 2022, FUJIFILM Corporation, a company which delivers effective solutions in a wide variety of fields to serve society, contribute to the quality of life, and enhance environmental sustainability, announced the CE approval of EG-740UT, a convex ultrasonic endoscope, for the upper gastrointestinal tract. 

The EG-740UT features a specialized guide wire locking mechanism as well as a new distal end configuration. Its distinct design allows endoscopic instruments to be visualized within the endoscopic field of view, with the goal of improving the ultrasound endoscope’s efficiency and user-friendliness during the procedure.

Furthermore, this new ultrasound endoscope includes the well-known “G-LOCK” mechanism, which can fixate the guidewire during intraprocedural instrument exchange, reducing the complexity and duration of instrument exchanges. 

Fujifilm intends to provide outstanding ultrasound image quality with advanced therapeutic capability by combining Fujifilm’s latest generation EG-740UT Ultrasound endoscope with the ARIETTA 850. The ARIETTA 850 FF ENDO from Fujifilm Healthcare is equipped with Fujifilm Healthcare’s ultrasonic transmission and reception technology eFocusing and image processing technology Carving Imaging, allowing it to render clear ultrasound images from the superficial to the very deepest areas of the abdomen. 

The newly compatible EG-740UT and Arietta 850 will go on sale from January 2023. 

Takemasa Kojima, Vice President at Endoscopy at FUJIFILM Europe GmbH, said, “The compatibility of Fujifilm’s high performance Ultrasound endoscopes with Fujifilm Healthcare’s flagship Ultrasound diagnostic equipment was highly anticipated since the acquisition of Hitachi’s Diagnostic Imaging Business back in 2021. We are incredibly proud that this milestone has come to fruition. We will continue with vigor, to bring together class leading, proprietary technologies, products, and services to deliver endoscopy solutions that will deliver better outcomes for patients.”

“Working with the very best Ultrasound technology throughout my career has been a real privilege, particularly as I have been able to support healthcare professionals to deliver the very best in patient care in some of the most tragic of circumstances. However, this new development takes us to new heights and I am incredibly proud that we can continue on that journey by pushing the boundaries of our technological capability and delivering endoscopy solutions that strive to enhance patients quality of life.” added Kurt Lauriers, EUS clinical specialist at Endoscopy at FUJIFILM Europe GmbH.

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, in order to reach USD 18.32 billion by 2027. The endoscopes market is estimated to register positive revenue growth owing to factors such as the rising prevalence of chronic diseases which require the use of endoscopes, such as irritable bowel syndrome (IBD), gastroesophageal reflux disease (GERD), peptic ulcer disease, and Crohn’s disease, increase in the number of geriatric population, increasing awareness and demand for minimally invasive surgeries, and rise in technological advancements in endoscopes, like image magnification, high-definition optical systems, and digital imaging are anticipated to bolster the market, thereby contributing to the growth of the endoscopes market during the forecast period from 2022-2027. 

Cala Health Published Data for its Transcutaneous Afferent Patterned Stimulation Therapy

On September 27, 2022, Cala Health, Inc., a bioelectronic medicine company transforming the standard of care for chronic disease, announced the data for validating the long-term safety and efficacy of its Cala transcutaneous afferent patterned stimulation (TAPS) therapy for essential tremor (ET) treatment.

Cala TAPS is claimed to reduce tremors without any loss of effect over time while improving the quality of life of patients living with ET. The retrospective post-market surveillance study, titled “Real-World Evidence of Transcutaneous Afferent Patterned Stimulation for Essential Tremor,” assessed the real-world efficacy of Cala TAPS therapy in 321 users who had completed at least 90 days of therapy. 

Key Findings of the study: 

  • TAPS reduced tremor power by 71%, confirming previous findings from the PROSPECT clinical study
  • More than half of patients experience a reduction of tremor power by at least 50%
  • No loss of effect was observed with use for longer than a year, with no significant reduction in patients’ tremor power improvement ratio between the first 90 days and beyond a year
  • Patients completing multiple sessions in a single day experienced no loss of effect when completing multiple sessions in a single day
  • Patients were instructed by their prescribing physician to use therapy as needed. Patients used therapy an average of 5 to 6 times per week

Along with the above findings, the study also concluded that the majority of patients reported gains in at least one of their important daily activities. This included 65% in drinking, 64% in writing, and 74% in eating. Also, among the patients who were taking tremor medication before starting Cala TAPS therapy, 24% observed a reduction in their tremor medication, while 14% stopped medication use. 

“Historically, patients with ET have had limited treatment options,” said Dr. Salima Brillman, lead author and a movement disorder neurologist at the Parkinson’s Disease and Movement Disorder Center of Silicon Valley. Dr. Salima also added, “The evidence, coupled with self-reported quality of life improvement and patient preference for TAPS, reinforce that TAPS is a valuable treatment option for patients with ET. It’s exciting to see advancements for individualized care within the movement disorder space for this patient population.”

Renee Ryan, CEO of Cala, said, “The fact that patients prefer Cala TAPS therapy over standard management options, with some able to reduce or discontinue medications, validates that our solution is transforming the standard of care for patients with essential tremor.” He added, “We are proud of this real-world outcome and remain dedicated to improving patients’ quality of life and expanding access and affordability for Cala TAPS therapy.”

According to DelveInsight’s “Neurostimulation Devices Market” report, the global neurostimulation devices market was valued at USD 5.82 billion in 2021, growing at a CAGR of 11.77% during the forecast period from 2022 to 2027, to reach USD 11.34 billion by 2027. The increase in demand for neurostimulation devices is predominantly attributed to the spike in the population suffering from neurological disorders such as epilepsy and migraine, escalating product demand as add-on therapy, and the shifting focus towards developing technologically advanced products, which is thereby anticipated to drive the global neurostimulation devices market during the forthcoming years.

Merit Medical Launched the Soft Tissue Biopsy System, TEMNO Elite™

On September 27, 2022, Merit Medical Systems, Inc., a leading manufacturer of proprietary disposable medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy, announced the commercial release of the TEMNO Elite™ Soft Tissue Biopsy System, in the United States. 

The device is indicated for use in various soft tissue locations such as liver, lung, lymph nodes, kidney, and other soft tissue suspect lesions. The device is designed to retrieve superior samples. Along with this, the TEMNO Elite’s Total Core™ Biopsy Technology obtains samples 72% larger than competitor side-notch, semi-automatic devices. 

The device features simplified tissue removal, allowing clinicians to retrieve full samples with an easy slide of a button. A valved coaxial introducer in the device enhances patient safety by reducing the risk of air entry and fluid leakage, particularly important during a lung biopsy. 

Stuart Aronson, MD, diagnostic radiology specialist at Texas Health Harris Methodist Hospital in Fort Worth, TX, said, “The sample quality of the TEMNO Elite is excellent,”. He also added, “The cores are noticeably and consistently larger than other devices. The valved coaxial introducer reduces procedural steps and blood leakage and helps to reduce the risk of pneumothorax and air embolism.”

“Merit is committed to helping physicians provide the best care possible for their patients—and this includes the crucial step of accurate diagnosis,” said Fred P. Lampropoulos, Merit Medical’s Chairman and CEO. He also commented, “The TEMNO Elite is the latest innovation in our portfolio of soft tissue biopsy devices, and it highlights Merit’s ability to understand clinician and patient needs and innovate and deliver technologies that advance patient care. We are pleased to continue our progress in improving diagnostic accuracy in pathology labs across the nation.” 

According to DelveInsight’s “Liquid Biopsy in Cancer Diagnostics Market” report, the global liquid biopsy in the cancer diagnostics market was valued at USD 7.64 billion in 2021, growing at a CAGR of 16.64% during the forecast period from 2022 to 2027 to reach USD 19.24 billion by 2027. The growing demand for liquid biopsy in cancer diagnostics devices is primarily associated with the rising incidence of cancers, growing demand for minimally invasive procedures, increasing demand for precision medicines, and technical innovation in product development, among other factors that will propel the market growth of liquid biopsy in cancer diagnostics during the forecast period. According to the DelveInsight Analysis, in the by-type segment of the liquid biopsy in cancer diagnostics, the service category is estimated to hold a significant market share in 2021. This is primarily owing to the various aspects of services catered by this category. Many companies are operating in the domain where they offer services about liquid biopsy ranging from sample collection to NGS analysis. 

Thermo Fisher Scientific Announced FDA Approval of Oncomine Dx Target Test

On September 27, 2022, Thermo Fisher Scientific, one of the leaders in serving science, received the U.S. Food and Drug Administration (FDA) approval of the Oncomine Dx Target Test as a companion diagnostic (CDx) to aid in the selection of patients with RET-fusion positive locally advanced or metastatic non-small cell lung cancer (NSCLC), RET-fusion positive advanced or metastatic thyroid cancer and RET-mutation positive advanced or metastatic medullary thyroid cancer who may be eligible for treatment with Lilly’s Retevmo. 

The Oncomine Dx Target test is a next-generation sequencing (NGS)-based test that can detect multiple alterations at once from a small sample size, allowing patients to be matched with the most appropriate targeted therapy as quickly as possible. 

In Japan, it is also approved as a companion diagnostic for Retevmo in the same indications. The test is the only globally distributable NGS CDx solution with regulatory approval in 17 countries for 15 targeted therapies, covering more than 550 million people worldwide. 

Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific, said, “Following the Oncomine Dx Target Test’s first approval in 2017, we have worked to advance access to companion diagnostics for targeted therapies on a global scale.” He also added, “As we continue to pursue additional approvals alongside our biopharma partners, we remain committed to broadening access to NGS-based testing to ensure patients and clinicians everywhere can benefit from it.”

According to DelveInsight’s “In-vitro Diagnostics Market” report, the global In-vitro diagnostics market was valued at USD 71.01 billion in 2021, growing at a CAGR of 4.71% during the forecast period from 2022 to 2027 to reach USD 93.60 billion by 2027. The rise in demand for in-vitro diagnostics is predominantly attributed due to the increasing prevalence of various infectious diseases, such as COVID-19, growing prevalence of cancers, increasing cases of hematological diseases, and increasing product development activities with respect to in vitro diagnostics, among others. As per the Delveinsight analysis, Asia-Pacific is expected to have the fastest growth in revenue in the overall in-vitro diagnostics market during the forecast period. This is due to the factors such as the increasing prevalence of cancers and the growing geriatric population related to hematological disorders such as anemia are expected to aid in the growth of the Asia-Pacific in-vitro diagnostics market.

Indigo Diabetes Enrolled First Participant in the Shine Clinical Trial 

On September 29, 2022, Indigo Diabetes N.V., a pioneering developer of medical solutions using nanophotonics, announced the enrolment of the first participant in Belgium in the SHINE clinical trial, which is designed to evaluate the longer-term stability of Indigo’s continuous multi-metabolite (CMM) device.

Indigo’s subcutaneously inserted CMM device is used for the continuous measurement of glucose, ketone, and lactate levels in people living with diabetes. Indigo Diabetes’ CMM sensor is a small spectrometer-on-a-chip that monitors multiple metabolites in-vivo simultaneously and continuously. Without the use of enzymes or fluorophores, the inert, miniature integrated silicon photonics spectrometer chip measures light absorption in the interstitial fluid to quantify the concentration of multiple metabolites at the same time. Once inserted beneath the skin, the CMM sensor is invisible to the naked eye and will securely and wirelessly connect to mobile devices to display and capture metabolite concentration profiles for the user. The measurements are powered by a rechargeable sensor battery. The sensor is expected to have a lifetime of up to two years. 

SHINE is an open-label, interventional, multicentre, prospective feasibility study designed to evaluate the safety of the implantation and preliminary performance of the SHINE SYSTEM. The device will be inserted for 6 months, with the overall study expected to last 12 months from the first participant’s first visit (FPFV) to the last participant’s last visit (LPLV). Up to 15 study participants with diabetes mellitus will be recruited across the following sites: University Medical Centre, Ljubljana in Slovenia, Antwerp University Hospital in Belgium, and Lapeyronie Montpellier University Hospital in France. 

Professor Christophe De Block, principal investigator of the Shine trial at Antwerp University hospital commented, “Continuous monitoring of glucose levels is key in managing diabetes to prevent devastating acute and long-term complications. The possibility of monitoring other biomarkers such as ketones and lactate will take continuous monitoring to the next level. It is a privilege to lead the SHINE clinical trial to evaluate the safety and performance of this ground-breaking novel technology.”

Danaë Delbeke, CEO, inventor, and co-founder of indigo diabetes N.V., added, “The start of the SHINE trial is an important milestone for Indigo and follows the successful conclusion of the GLOW trial earlier this year, the results of which we’ve submitted to a peer-reviewed journal for publication. Many multi-metabolite monitoring devices under development sit on the skin and are highly visible, which some people do not like because they can feel self-conscious, stigmatized and uncomfortable. Indigo’s continuous multi-metabolite monitor is subcutaneously inserted and is designed to be inconspicuous. We look forward to seeing how it performs in this longer-term stability trial.”According to DelveInsight’s “Blood Glucose Monitoring Systems Market” report, the global blood glucose monitoring systems market was valued at USD 13.06 billion in 2021, growing at a CAGR of 7.72% during the forecast period from 2022 to 2027, to reach USD20.40 billion by 2027. Factors such as the increasing prevalence of diabetes, the growing burden of the geriatric population, the spike in technologically advanced glucose monitoring devices, increasing product launches, and others are expected to drive the overall blood glucose monitoring systems market during the forecast period of 2022-2027.