VARON Launched the Game-changer in the Field–New VP Series Portable Oxygen Concentrator

On July 19, 2023, VARON, a leading oxygen concentrator manufacturer, announced the launch of a game-changer portable oxygen concentrator VP-2. 

A new member of the VP series, VP-2 is incorporated with innovative technology and advanced features. With user-friendly controls for easy operation, VP-2 provides efficient and reliable oxygen therapy to patients in need wherever they go.

The new oxygen concentrator comes with a replaceable battery and its body is still lighter and more compact than its predecessor VP-1 which makes it more appropriate for outdoor use. 

The Dual Oxygen Supply Mode of the VP-2 oxygen concentrator sets it apart from other products on the market. It automatically releases oxygen every three seconds when no inhalation or a traditional pulse flow oxygen supply is detected. Gentle or shallow breathing during sleep or due to certain pulmonary diseases can be effectively sensed by this feature which is not possible with pulse flow mode. 

Darren Wang, CEO of VARON commented, “We are more excited than anyone to introduce the new product to the market.” Darren added, “Our goal is to make oxygen therapy more accessible by providing reliable, efficient, and affordable solutions for anyone in need. With VP-2 coming out, we believe we are much closer to the goal.” 

As per DelveInsight’s “Medical Oxygen Concentrators Global Market” report, the medical oxygen concentrators market is estimated to advance at a CAGR of 5.63% during the forecast period (2023-2028). The increase in demand for medical oxygen concentrators is primarily attributed to the increased prevalence of respiratory disorders like chronic obstructive pulmonary disorder (COPD), sleep apnea, hypoxemia, pulmonary edema, and other respiratory illness, further increased demand in geriatric and bedridden patients, and steep rise in demand of medical oxygen concentrators after COVID-19 pandemic across the world is anticipated to bolster the market, thereby contributing to the growth of the medical oxygen concentrators market during the forecast period from 2023-2028.

Biostrap Launched a Wrist-Worn Digital Health Monitoring Device

On July 19, 2023, Biostrap, Austin, Texas–based company announced the launch of a new Kairos wearable device meant for data visualization of the autonomic nervous system.

The device is intended for the quantification of data from the sympathetic and parasympathetic branches which could only be accessed through electrocardiogram chest straps.

The wrist-wear gadget can be worn on either the forearm or the bicep. The device uses a high-sensitivity, complementary metal-oxide-semiconductor (CMOS) optical sensor to capture raw photoplethysmography (PPG) data and then computes biometrics such as active and resting heart rate, HRV, beat-to-beat intervals, and respiratory rate, as well as measuring sleep-related parameters.

The Kairos system also has a component for monitoring stress resilience, which allows users to determine whether they are in fight-or-flight or rest-and-digest mode. This is tracked by the system throughout the day and in real-time.

The system also has a long battery life and fast syncing speeds thanks to Ambiq technology. 

“We are thrilled to launch Kairos and our new Spot Check feature,” said Sameer Sontakey, Biostrap CEO and co-founder. Sameer added, “Our dedicated team has worked tirelessly to create this cutting-edge culmination of hardware and software that positions Biostrap as the leader in quantifying clinical-grade heart rate variability (HRV) parameters and providing researchers and health tech visionaries invaluable insights into their patients’ and clients’ autonomic nervous system like never before.”

 According to DelveInsight’s “Digital Health Market” report, the global digital health market was valued at USD 178.37 billion in 2022 and is estimated to grow at a CAGR of 18.25% during the forecast period from 2023 to 2028 to reach USD 486.55 billion by 2028. The digital health market is observing remarkable market growth due to the growing awareness, adoption of digital healthcare, and the rising demand for Artificial intelligence (AI), IoT, and others in the healthcare industry. Further, the increasing patient pool suffering from chronic disease and the rising burden of the geriatric population across the globe will increase the need for remote and virtual patient care, leading to the increased demand for digital health. Additionally, the growing demand for remote patient monitoring and mobile health applications, increasing penetration of smartphones in the healthcare industries along with the increasing product or service launches & approvals, and the presence of key players in the market, among others will create a requisite for the digital health in the market. Therefore, the market for digital health is estimated to grow at a substantial CAGR during the forecast period from 2023 to 2028. 

MediView Augmented Reality Visualization, Navigation Platform Received FDA Clearance

On July 20, 2023, MediView XR received the US Food and Drug Administration 510(k) clearance for its XR90 augmented reality-based visualization and navigation platform, designed for adjunctive use in minimally invasive ultrasound and CT-guided needle-based procedures. 

The augmented reality platform developed by MediView promises to overcome the long-standing shortcomings of medical imaging technologies. This covers the 2D imagery that forces medical professionals to turn their heads away from the patient’s procedure site. This incident may impair the clinician’s ability to focus and make them feel less confident, affecting the results.

Clinicians can observe ultrasonography and displays of other procedural information using Microsoft’s HoloLens 2 AR headgear, which will improve workflow.

According to MediView, the XR90’s 3D “x-ray vision” helps it to transcend the limits of 2D imaging. This makes it possible for doctors to see a patient’s entire internal anatomy in three dimensions beneath the skin. This entails the projection of bone, tissue, organs, and vasculature in 3D virtual models based on CT imaging. To carry out minimally invasive operations like biopsies and tumor ablations, it combines CT with live ultrasound.

The XR90 also features a 3D holographic anatomy display based on CT and a holographic light beam that tracks and shows the route of a doctor’s instrument. Its live ultrasound beam, which resembles a flashlight beam, and projected and displays anatomically into the patient as the physician scans.

The system was created to offer visual references and information for the study of procedural choices. It aids in preoperative planning, streamlines productivity, and gives the user better ergonomics. The manufacturer claims that using XR90 in conjunction with imaging standards of care is suggested.

“This is not only the first 510(k) clearance for MediView, but it is the first 510(k) clearance for an augmented reality device utilizing live imaging combined with 3D XR visualization for pre- and intra-operative indications for use, which sets the stage for further advancements in augmented reality in the healthcare space,” said Adam Cargill, director of quality, regulatory and clinical affairs at MediView. 

Mina Fahim, president and CEO of MediView said, “We are in a new era of visualization, collaboration, and data insights in healthcare that can create patient, clinician, and financial benefits.” Mina Fahim further added, “XR90 expands the MediView portfolio of solutions available to practitioners as they look to simplify, democratize, and inform care delivery with the ultimate goal of improving and expanding access to the best care.” 

According to DelveInsight’s “Surgical Navigation Systems Market” report, the global surgical navigation systems market was valued at USD 7,753.34 million in 2022, growing at a CAGR of 6.76% during the forecast period from 2023 to 2028. The demand for surgical navigation systems is primarily being boosted by the increasing prevalence of various chronic diseases such as stroke, Alzheimer’s, cerebrovascular disease, and others. Further, the rising incidences of orthopedic disorders, especially among the geriatric population, along with increasing demand for minimally invasive surgical procedures, and growing activities for research and development for surgical navigation systems are thereby contributing to the overall growth of the surgical navigation systems market during the forecast period from 2023-2028.

Beckman Coulter Received the US FDA Clearance for DxC 500 AU Chemistry Analyzer

On July 25, 2023, Beckman Coulter Diagnostics, a clinical diagnostics leader announced that the company has received the US FDA clearance for its new DxC 500 AU Chemistry Analyzer, an automated chemistry analyzer. 

The approval expands the company’s clinical chemistry offering and demonstrates an ongoing commitment to product innovation in the in vitro diagnostic industry. 

DxC 500 AU Chemistry Analyzer is designed for small-to-medium-sized laboratories and optimizes laboratory workflows and supports critical clinical decisions. 

The DxC 500 AU Chemistry Analyzer employs standardized assays and reagents common throughout Beckman Coulter’s AU clinical chemistry analyzer platform. Using standardized assays and reagents allows independent laboratories and those part of integrated networks to give consistent, harmonized data across AU platforms for clinical decision-making and patient outcomes. 

With the increased demand for improved accuracy and reliability of results, the DxC 500 AU Chemistry Analyzer’s broad menu of 120-plus assays has been independently and objectively verified for quality performance, bolstering confidence in result integrity.

The DxC 500 AU Chemistry Analyzer is exclusively intended for in vitro diagnostic usage. 

Kathleen Orland, Senior Vice President, Business Unit, General Manager Chemistry and Immunoassay for Beckman Coulter Diagnostics said, “We are pleased to expand our offering of reliable clinical chemistry series.” Kathleen added, “In addition to commutable patient results across low-to-high-volume chemistry platforms, application of the same reagents has a positive impact on inventory and cost across a health system.”

According to DelveInsight’s “Clinical Chemistry Analyzers Market” report, the global clinical chemistry analyzers market was valued at USD 12.38 billion in 2022 and will grow at a CAGR of 4.82% during the forecast period from 2023 to 2028 to reach USD 16.39 billion by 2028. The clinical chemistry analyzers market is observing remarkable market growth due to the factors such as the growing prevalence of chronic diseases and the rising burden of the geriatric population. Furthermore, the surging demand for early diagnosis of disease, the increasing importance and awareness of point-of-care testing, surging technological advancements in the devices along with the increasing product launches and approvals, the presence of key players in the market, and other factors will create a requisite for the clinical chemistry analyzers in the market. Therefore, the market for clinical chemistry analyzers is estimated to grow at a substantial CAGR during the forecast period from 2023 to 2028.

Magnus Medical Announced Treatment of First Participants in Study Using SAINT Neuromodulation System for Major Depression 

On July 20, 2023, Magnus Medical, Inc., a medical device company and developer of brain stimulation technology for the treatment of neuropsychiatric disorders, announced the treatment of the first participants in the Open-Label Optimization (OLO) Clinical Trial evaluating the effectiveness of the Magnus Neuromodulation System with SAINT™ Technology for the treatment of Major Depressive Disorder (MDD).

Up to 1,000 adults suffering from a major depressive episode who have failed to receive satisfactory improvement from prior antidepressant medication will be enrolled in nine clinics nationwide. 

“We are very pleased to announce the start of the OLO clinical trial with SAINT therapy for people with MDD who are ineffectively treated by prior antidepressant medications,” said Brandon Bentzley, M.D., Ph.D., co-founder and chief scientific officer of Magnus. Brandon commented, “Results from the previous randomized controlled trial were extremely promising—79% of participants experienced relief from their severe depression after receiving SAINT treatment. Given the enormous need for acute care in depression, we knew we needed to make SAINT treatment more widely available while building a body of clinical data.

“The OLO trial is the first time the SAINT Neuromodulation System will be studied at multiple sites, allowing a large sample size of adults suffering from clinical depression to access the rapid-acting, personalized treatment for their treatment-resistant major depression,” continued Bentzley.

David Carreon, M.D., a primary investigator and the first to enroll in the OLO study at Acacia Mental Health, Sunnyvale, Calif mentioned, “SAINT therapy is the beginning of a revolution in psychiatry: fast, effective, and personalized treatments that give hope to patients who have failed to receive relief from traditional approaches.” David said, “It could profoundly change the way we care for those with treatment-resistant depression and be a model for addressing other conditions as well. Our clinic specializes in caring for the hardest and most hopeless, depressed patients by providing the best treatments available. We have started to enroll participants and are eager to find out whether the overwhelmingly positive results seen at the initial trials at Stanford will translate to our patients.”

“We are delighted to have our first participants enrolled in the OLO study and happy to be working with Magnus to help provide a rapidly acting solution that may solve a fundamental problem in treating pervasive major depression,” said Robert Bota, M.D., a primary investigator in the OLO study at Brain Health Solutions, Costa Mesa, Calif.

According to DelveInsight’s “Neuromodulation Devices Market” report, the global neuromodulation devices market was valued at USD 5.71 billion in 2022, growing at a CAGR of 8.95% during the forecast period from 2023 to 2028, to reach USD 9.56 billion by 2028. The demand for neuromodulation devices is primarily motivated by the increasing prevalence of neurological disorders coupled with the rising aging population, expansion of the devices to other chronic indications and target applications, technological advancement in the product portfolio, rising government initiatives to raise awareness among patient regarding neurological disorders, among others.

Francis Medical Announced First Patient Treated in VAPOR 2 Pivotal Study for Water Vapor Ablation of Prostate Cancer 

On July 19, 2023, Francis Medical, Inc., a privately held medical device company developing an innovative and proprietary water vapor ablation therapy for the treatment of prostate, kidney, and bladder cancer, announced that the first patient has been treated in the company’s VAPOR 2 pivotal clinical study which aims to evaluate the safety and efficacy of its Vanquish minimally invasive water vapor ablation therapy for managing prostate cancer.

A prospective, multicenter, single-arm trial expects to treat 235 patients with intermediate-risk, localized prostate cancer at up to 30 clinical sites in the US. 

Prostate cancer is a dangerous disease that is frequently treated with medicines that result in side effects such as urine incontinence and erectile dysfunction. The Vanquish water vapor technology from Francis Medical uses the thermal energy stored in a few drops of sterile water to provide targeted therapies to malignant tissue via a simple transurethral procedure. The therapy is intended to destroy cancer cells while protecting surrounding structures, reducing the possibility of life-altering side effects that are frequent with previous prostate cancer therapies.

The one-year follow-up results from the VAPOUR 2 study will be used to support an FDA submission for US market clearance, according to the company. For five years, VAPOUR 2 participants will be followed to collect long-term cancer results.

“The first patient treated in the VAPOR 2 study is an important milestone for the company,” said Michael Kujak, Francis Medical president and chief executive officer. Michael added, “We would like to thank our employees, investors, patients, and physician partners for bringing us to this stage. We are more confident than ever that this groundbreaking technology will ultimately become the first-line treatment of choice for men and their doctors.” 

Michael Hoey, Francis Medical founder, and chief technology officer commented, “The vision that started this company and continues to drive us is to create a better experience for the patient.” Hoey added, “Water vapor is an ideal tool for accomplishing this goal. It is simple, natural, and gentle, but powerful. The first VAPOR 2 study treatment is an important milestone bringing us one step closer to getting this groundbreaking technology into the hands of urologists and their patients.” According to DelveInsight’s “Ablation Devices Market” report”, the global ablation devices market is estimated to grow at a CAGR of 11.65% during the forecast period from 2023 to 2028. Factors such as the increasing incidence of cancers such as liver cancer, the rising prevalence of chronic pains such as musculoskeletal pains, the rising prevalence of cardiac arrhythmias such as atrial fibrillation, and the rising regulatory approvals for technologically advanced ablation devices. Therefore, the market for ablation devices is estimated to grow at a significant CAGR during the forecast period from 2023 to 2028.