Built on a legacy of life-saving products and tailored for modern healthcare professionals, the LIFEPAK 35 platform features a slim, lightweight, ergonomic design with a large intuitive touchscreen for a customizable clinical experience. The LIFEPAK 35 allows for trend monitoring to assist caregivers in decision-making with its configurable events and connected capabilities for patient data, thereby supporting advanced patient care.
As per DelveInsight’s “Defibrillators Market Report,” the global Defibrillators Market was valued at USD 10.19 billion in 2023 and is growing at a CAGR of 3.11% during the forecast period from 2024 to 2030, to reach USD 12.24 billion by 2030. The demand for defibrillators is primarily associated with the growing incidence of cardiac disorders, integration of advanced technology, increasing investments by government and private manufacturers, and rising awareness programs regarding cardiovascular disorders and the usage of defibrillators, among others.
Qiagen Launched Advanced QIAstat-Dx Respiratory Panel in Malaysia
On June 04, 2024, Qiagen launched an improved version of its QIAstat-Dx Respiratory SARS-CoV-2 Panel in Malaysia, following approval by the Medical Device Authority (MDA).
This new version, which holds a CE-IVD mark, enhances its detection capability from 22 to 23 pathogens and is compatible with the QIAstat-Dx Rise system, a high-capacity variant of the QIAstat-Dx automated syndromic system.
This upgraded panel is a multiplexed nucleic acid real-time PCR test designed for the qualitative detection of common pathogens presenting with influenza-like symptoms. It can now detect and differentiate among 23 viral and bacterial targets, including Chlamydophila pneumoniae.
The QIAstat-Dx system, designed for laboratory use, utilizes cost-efficient, single-use cartridges with built-in sample processing and on-board reagents. By employing multiplex real-time PCR, it can detect and differentiate multiple pathogens, delivering results in about an hour. This rapid and accurate testing enables healthcare providers to make informed clinical decisions swiftly, facilitating timely therapeutic interventions, which is especially crucial for managing upper respiratory tract infections (URTIs).
QIAstat-Dx solutions and syndromic tests are available in over 100 countries worldwide. These systems have been installed in various hospitals, including those under the Malaysian Ministry of Health, with the first installation in 2019. QIAstat-Dx is available in two formats: the QIAstat-Dx Analyzer, which integrates up to four Analytical Modules, and the higher-capacity QIAstat-Dx Rise, which can conduct up to 160 tests per day using eight Analytical Modules.
According to DelveInsight’s “Point of Care Diagnostics Market Report”, the global point of care diagnostics market is estimated to grow at a CAGR of 6.61% during the forecast period from 2024 to 2030. The demand for point of care diagnostics is primarily being boosted by the increasing patient population suffering from various lifestyle disorders such as diabetes and cardiovascular diseases among others, the rising prevalence of infectious diseases, growing awareness regarding health and disease-free life, and innovation in product development among others, thereby contributing to the overall growth of the point of care diagnostics market during the forecast period from 2024-2030.
Evolution Optiks Secured 510(k) Clearance For New Eye Examination Device
On June 05, 2024, Light field technology company Evolution Optiks secured 510(k) clearance from the US Food and Drug Administration (FDA) for its LFR-260, which is claimed to be the world’s first light field-powered subjective tele-refractor. This follows the European CE mark obtained in March 2024.
The FDA’s approval is grounded on findings from a multi-center, open-label, 2×2 cross-over study encompassing 108 patients who received thorough routine eye examinations.
Furthermore, the agency has created a new product classification to differentiate the LFR-260 from traditional Class I 510(k) exempt manual refractors. According to the company, this classification better reflects the capabilities of a light field-based refractor.
The LFR-260 boasts a compact and portable design, featuring full digital operation that can be remotely controlled via tablet, rendering it well-suited for telemedicine applications.
Its technology incorporates integrated microlens arrays and ultra-high pixel density displays, enabling the real-time generation of ray-traced, multi-focal optotypes.
Additionally, Evolution Optiks’s QuadView technology stands out in the LFR-260. This feature allows the simultaneous display of slightly varied prescriptions, empowering patients to select the most suitable vision correction based on their subjective experience, independently of practitioner influence.
Evolution Optiks chairman Andreas Kusay said, “With both FDA approval and CE mark in hand, we are gearing up for the product launch of the LFR-260. With a combined population of close to 800 million people, the US and the European Economic Area are core markets with rapidly growing healthcare sectors, which offer abundant opportunities for forward-looking products and technologies. The flagship of our Optokare line is set to stir up the market and is a strong candidate to become the standard of modern refraction.”
As per DelveInsight’s “Ophthalmology Devices Market Report,” the global ophthalmology devices market is estimated to grow at a CAGR of 4.91% during the forecast period from 2024 to 2030. The demand for Ophthalmology Devices is primarily being boosted by the increasing prevalence of eye disorders such as cataracts, glaucoma, and refractive disorders among others. Additionally, growing technological advancement in the domain of ophthalmology, increasing ocular injuries due to trauma, and growing geriatric population are some of the contributing factors to the growth of the Ophthalmology Devices market during the forecast period from 2024-2030.
FDA-Approved Microbot Medical Endovascular Surgical Robot Trial
On June 04, 2024, Microbot Medical announced that it received FDA approval to commence its human clinical trial for the Liberty Endovascular Robotic Surgical System.
The pivotal human clinical trial is integral to the company’s investigational device exemption application. It will be conducted in the U.S., with Microbot Medical having entered into a clinical trial service agreement with a prominent academic medical center. The company stated that it is also actively seeking additional collaborations with other top-tier medical centers to join the trial.
Microbot developed the Liberty surgical robot for potential application in neurovascular, cardiovascular, and peripheral vascular procedures.
The system features a compact design and remote operating capabilities aimed at minimizing radiation exposure and physical strain on physicians. Microbot anticipates that Liberty’s remote operation could potentially position it as the first system to democratize endovascular interventional procedures. The company applied for FDA investigation device exemption for the surgical robot in February. Additionally, it recently augmented its U.S. operations in anticipation of the IDE submission to ready itself for the subsequent stages. Microbot is buoyed by the favorable results of its good laboratory practices (GLP) pre-clinical study. Other recent developments involving Microbot include a $2.154 million settlement of a lawsuit concerning a securities purchase agreement.
“The recent authorization by the FDA to commence our pivotal clinical study, following submission of the results of our extensive pre-clinical studies and tests, reinforces our confidence in our innovative technology,” CEO and President Harel Gadot said in a news release. ”It is also a testament to our commitment to meet meaningful milestones as we continue our path towards potential regulatory clearance and subsequent commercialization in the US and other regions across the globe.”
According to DelveInsight’s “Surgical Robotic Systems Market Report”, the global Surgical Robotic Systems market was valued at USD 5.02 billion in 2023, growing at a CAGR of 11.50% during the forecast period from 2024 to 2030 to reach USD 9.64 billion by 2030. The demand for Surgical Robotic Systems is witnessing a surge due to increasing surgical procedures which can be attributed to various factors such as the increasing geriatric population who form a big part of an at-risk population for prostate cancer, valvular diseases, endometriosis among other diseases, the growing need for robot-assisted surgery systems due to the growing inclination towards minimally invasive surgical approaches, and the innovation in product development which is paving the way for miniaturized surgical robots ultimately contributing in the overall growth of the Surgical Robotic Systems market during the forecast period from 2024-2030.
FDA Greenlighted Clinical Trials for Nexalin’s Insomnia and Anxiety Therapy Headset
On June 03, 2024, Nexalin Technology Inc. announced that the US Food and Drug Administration (FDA) offered feedback and agreed upon the design for its forthcoming clinical investigations concerning insomnia and anxiety related to its latest product, the Gen-3 HALO Clarity. This device utilizes non-invasive deep intracranial frequency stimulation (DIFS) and is intended to target these conditions.
Following the completion and assessment of the studies, Nexalin intends to submit a De Novo request application to the FDA for the HALO. The De Novo request offers a marketing pathway for the classification of innovative new medical devices.
The pilot and pivotal studies on insomnia and anxiety are slated to begin in the third quarter. Each pivotal study will involve 75 patients receiving active treatment and 75 patients undergoing sham treatment. The aim is to assess HALO’s efficacy in alleviating symptoms of insomnia and anxiety, respectively.
These two studies aim to expand upon the favorable outcomes observed in previous published clinical studies assessing Nexalin’s Gen-3 HALO, which incorporates the new advanced DIFS waveform.
“We are proud to have arrived at a consensus with the FDA for the clinical protocols to evaluate the safety and efficacy of HALO in both anxiety and insomnia,” said David Owens, MD, chief medical officer of Nexalin, in a release. “This marks a major milestone for Nexalin and a significant step forward in the regulatory pathway. These studies will build upon our extensive prior published clinical studies in the US and Asia, which have repeatedly demonstrated the efficacy of our proprietary waveform.”
Mark White, CEO of Nexalin, added, “We have commenced a large production run of over 500 units, a key step that will support the FDA protocols for the planned studies. Overall, we believe the progress we have made is a major feat in a relatively short amount of time-from vision to design, pre-manufacturing to full manufacturing, and usability testing to protocol approval. We look forward to providing further updates on our clinical studies as developments unfold.”
According to DelveInsight’s “Sleep Tech Devices Market Report”, the global sleep tech devices market was valued at USD 16,941.46 million in 2023, growing at a CAGR of 17.31% during the forecast period from 2024 to 2030 to reach USD 44,038.42 million by 2030. The demand for sleep tech devices is primarily being boosted by the increasing patient population suffering from various sleep disorders such as insomnia, obstructive sleep apnea, and others, the surge in cases of depression, increasing number of risk factors such as obesity and smoking among others associated with causing poor sleep, rise in the number of sleep awareness campaigns and programs highlighting the importance of sleep, and innovation in product development among others, thereby contributing to the overall growth of the sleep tech devices market during the forecast period from 2024-2030.
KORU Medical Systems Announced a New Feasibility Study With Commercialized Oncology Biologics
On June 04, 2024, KORU Medical Systems, Inc., a prominent medical technology company specializing in the development, manufacturing, and distribution of innovative and patient-centered large-volume subcutaneous infusion solutions, announced a partnership with a global pharmaceutical firm to launch a feasibility study. This study will utilize KORU Medical’s Freedom Infusion System (the “Freedom System”) for the delivery of an FDA and EMA approved subcutaneous oncology biologic drug. Currently, this drug is administered manually using a syringe by healthcare professionals.
The Freedom System is a fully mechanical ambulatory drug delivery device, boasting 11 drugs approved on its label and utilized by over 40,000 patients worldwide. Engineered to administer large volumes of biologic medications ranging from 2mL to over 100mL subcutaneously, this system empowers patients to self-administer their therapy at home or be administered by healthcare professionals in a clinic setting.
Transitioning from intravenous (IV) biologics to subcutaneous administration formulations is an emerging trend in the oncology market. Research indicates that subcutaneous administration of oncology therapy streamlines treatment, alleviates strain on hospitals, and enhances patients’ quality of life. With the emergence of novel subcutaneous drug therapies, there exists an opportunity to create drug delivery administration solutions that optimize drug administration.
“This collaboration presents an exciting, new opportunity to enter the growing oncology subcutaneous biologic market to solve significant unmet needs in the delivery of this life-saving therapy with our patient-centric solutions,” said Linda Tharby, KORU Medical’s President and CEO. Linda Tharby went on to say, “There are multiple subcutaneous oncology biologics currently approved using manual administration with an estimate of over one million global infusions. Upon successful completion of the feasibility study, we anticipate progressing to commercialization of the Freedom System for this drug within the following 12 months.”
According to DelveInsight’s “Oncology Drugs Market Report”, the global oncology drugs market was valued at USD 179.96 billion in 2023, growing at a CAGR of 12.74% during the forecast period from 2024 to 2030, in order to reach USD 368.22 Billion by 2030. The oncology drugs market is witnessing a positive market growth owing to the factors such as rising prevalence of various cancers such as lung cancer which accounted for the highest number of cancer-related deaths and highest cancer incidence in 2021, and presence of factors such as growth in aging population wherein age plays a key role in cancer development in certain cancer types such as prostate and breast cancers. Moreover, the growing focus on developing targeted therapies such as CAR-T cell therapies to provide a more pronounced therapeutic effect is further driving the oncology drugs market as new products are gaining regulatory approvals for cancer treatment.
