The EVERESSE device was designed to address the challenges faced by patients and providers with older monopolar radiofrequency technologies. It provided an advanced solution for treating skin laxity, fine lines, and wrinkles, emphasizing efficacy and patient comfort. Using Targeted Thermal Precision Technology, the device delivered thermal RF energy to the dermis while protecting the epidermis, promoting collagen production and tissue coagulation for visible skin lifting and tightening.
Unlike earlier devices with multi-pulse energy, EVERESSE delivered a single consistent RF pulse, supported by water cooling, improving both safety and comfort. It’s curved, tilted tip allowed for better skin contact, and treatments were customizable with two handpieces for the face and smaller areas. Visible results were noted immediately, with optimal improvements seen at 8 to 12 weeks.
“There has been limited meaningful innovation in the monopolar RF market – treatments are painful for patients and expensive consumables and long treatment times create headaches for providers. Our goal with EVERESSE – as with all our technologies – is to bring devices to market that deliver on an unmet need and offer superior clinical efficacy, patient experience, and return on investment. Working alongside Classys, a world-class leader in energy-based devices, we expect to shake up the U.S. monopolar RF market with EVERESSE in the same way we’ve done for CO2 and laser hair removal,” says Gabe Lubin, Founder & CEO of Cartessa Aesthetics.
“Recognizing that skin tightening and rejuvenation are the fastest-growing indications in the U.S., we are confident that EVERESSE will meet the unique needs of this market. Our advanced, non-invasive solution offers safe and comfortable treatments for patients of all skin types, delivering immediate and lasting skin tightening and lifting results. We look forward to expanding our presence in the U.S. and establishing EVERESSE as the new gold standard in skin tightening and lifting,” adds Seung Han Baek, CEO of Classys, Inc.
According to DelveInsight’s “Medical Aesthetic Devices – Market Insights, Competitive Landscape, and Market Forecast – 2030”, the global medical aesthetic devices market was valued at USD 13,533.26 million in 2023, growing at a CAGR of 11.46% during the forecast period from 2024 to 2030, to reach USD 25,808.43 million by 2030. The increase in the market for medical aesthetic devices is predominantly owing to an exponential rise in the aging population and an increase in the adoption of various aesthetic procedures. Additionally, the growing awareness among the population to look aesthetically presentable and also regarding the various cosmetic procedures performed across the globe is likely to boost the market. Also, shifting preferences towards less complex minimally invasive or non-invasive aesthetic procedures, a rise in obesity among the population, and growing technological advancement in the product arena, among others are some of the key factors expected to raise the market for these devices during the forecast period from 2024 to 2030.
LogicMark Launched Revolutionary Medical Alert Device, Freedom Alert Max, Offering Cellular Communication Technology and 24/7 Assistance
On November 19, 2024, LogicMark, Inc. announced the release of the Freedom Alert Max, an advanced addition to its on-the-go product line. The medical alert device incorporated over-the-air updates, enabling regular feature enhancements like medication reminders and improved fall detection algorithms. It included geofencing for dementia and Alzheimer’s patients, cellular communication, and access to the 988 Lifeline. Combining 24/7 monitored alert capabilities with cell phone convenience, the device addressed the increasing demand for modern, mobile technology tailored for seniors and their caregivers.
LogicMark introduced the Freedom Alert Max, a groundbreaking fall detection device with emergency video access via the Care Village app. Equipped with dual cameras for live caregiver visuals during emergencies, the device supported seniors in crises by including a pre-programmed suicide and crisis lifeline (988). Its advanced fall detection technology adapted over time, reducing false alarms and predicting falls. Features like GPS, geofencing, and 24/7 monitoring enhanced safety and independence. The device, paired with a caregiver app, simplified use, coordination, and emergency communication.
“Today’s aging, but still active, population deserves access to smart and intuitive technology that empowers them to be independent. Requiring aging adults to keep up with and charge multiple devices to feel safe can be cumbersome and unmanageable. It’s also critical for them to receive help within the first hour of a fall or another emergency to decrease any potential negative effects on their physical or mental well-being,” said Chia-Lin Simmons, CEO of LogicMark. “Freedom Alert Max solves these challenges with its user-friendly operating system and robust platform. We remain committed to using a predictive approach that strengthens responsiveness and prevents the possibility of accidents. We’re honored to provide aging adults with groundbreaking, accessible technology designed for optimal ease, but also provides their families and care teams with greater peace of mind around the well-being of their loved ones.”
According to DelveInsight’s “Personal Emergency Response Systems (PERS) – Market Insights, Competitive Landscape, and Market Forecast – 2030”, the global Personal Emergency Response Systems (PERS)/Medical Alert Systems market was valued at USD 6,602.01 million in 2023, growing at a CAGR of 9.60% during the forecast period from 2024 to 2030 to reach USD 11,425.98 million by 2030. The Personal Emergency Response Systems (PERS)/Medical Alert Systems market is witnessing positive growth owing to various factors such as a rise in the geriatric population, an increase in the prevalence of falls in older adults, the surge in PERS or medical alert system products launch, increasing prevalence of chronic diseases such as Alzheimer’s disease (AD), and improvements in healthcare infrastructure facilities across the globe. Therefore, the market for Personal Emergency Response Systems (PERS)/Medical Alert Systems is estimated to grow at a significant CAGR during the forecast period from 2024 to 2030.
GE HealthCare Received FDA Clearance for Head-Only SIGNA MAGNUS 3.0T MRI System
On November 13, 2024, GE HealthCare received FDA 510(k) clearance for its SIGNA™ MAGNUS, a 3.0T head-only MRI scanner. This advanced system was designed to enhance clinical imaging and neuroscience applications, with capabilities to detect neurological, oncological, and psychiatric conditions.
The FDA clearance of SIGNA MAGNUS highlighted GE HealthCare’s advancements in neuroimaging. The system incorporated an innovative asymmetrical, high-efficiency head-only gradient coil design, which enhanced gradient performance due to its reduced inner diameter tailored for neuroimaging needs. The design shifted the gradient iso-center to the patient’s coil edge, facilitating head access and addressing shoulder width limitations. This head-only configuration enabled MAGNUS to deliver significantly higher gradient amplitude and slew rates compared to traditional 60cm or 70cm bore whole-body MRI systems, marking a notable milestone in neuroimaging technology.
“Obtaining FDA clearance further validates our commitment to not only innovating but also in delivering clinical technologies that have real-world impact,” said Jason Polzin, GM, MR Applications Platform and Research Technologies, GE HealthCare. “With SIGNA MAGNUS, we are providing neuroradiologists and neuroscience researchers a tool that supports advanced imaging and biomarker research and discovery previously impossible on conventional systems. It is our intent to make SIGNA MAGNUS widely available as a fully cleared commercial product.”
The enhanced capabilities of the SIGNA MAGNUS system provide ultra-high anatomical resolution with shorter scan times. Its ability to visualize brain function, microstructure, and micro-vasculature through innovations such as ODEN (Oscillating Gradient Diffusion Encoding) which uses oscillating gradients to provide cellularity contrast which can be important for neurological oncology. The intention is to leverage the high-gradient performance of SIGNA MAGNUS capabilities to allow for advanced research scanning such as high B-value diffusion imaging, fMRI for investigating the BOLD (Blood Oxygen Level Dependent) response and measurement of slow CSF (Cerebral Spinal Fluid) flow.
“We’re very excited about the capabilities SIGNA MAGNUS provides,” said Kawin Setsompop, PhD, Associate Professor of Radiology and by courtesy Electrical Engineering, Associate Chair of Research Strategic Development, Stanford University. “I plan to leverage the gradient performance to look at microstructures with diffusion imaging, such as axonal diameter. Additionally, using the high slew rate for efficient readout in terms of EPI and spiral to sample k-space faster will help achieve higher resolution with fewer artifacts.”
As per DelveInsight’s “Magnetic Resonance Imaging Devices – Market Insights, Competitive Landscape, and Market Forecast – 2030”, the global magnetic resonance imaging devices market was valued at USD 7.79 billion in 2023, growing at a CAGR of 6.37% during the forecast period from 2024 to 2030 to reach USD 11.28 billion by 2030. The magnetic resonance imaging devices market is witnessing positive growth owing to factors such as the rising cases of severe chronic diseases like various cancers, cardiac abnormalities, and others, further rapid technological developmental activities, growing geriatric population, rising adoption owing to non-invasiveness, thereby contributing to the growth of the magnetic resonance imaging devices market during the forecast period.
FDA Granted De Novo Authorization to OMRON Healthcare for New Blood Pressure Monitors with AI-Powered AFib Detection Feature
On November 14, 2024, OMRON Healthcare announced that the U.S. Food and Drug Administration (FDA) granted De Novo authorization for its innovative home blood pressure monitors. These devices feature AI-powered atrial fibrillation (AFib) detection using the IntelliSense™ AFib algorithm. In a groundbreaking advancement, the machine learning algorithm analyzes the Pressure Pulse Wave recorded during blood pressure measurement to detect AFib, a major stroke risk factor. This marks a significant milestone in medical device technology for home healthcare.
“OMRON Healthcare is making AFib screening a more integral part of our blood pressure monitoring experience as part of our Going for Zero mission to eliminate heart attack and stroke,” said OMRON Healthcare President and CEO Ranndy Kellogg. “AFib is a serious condition that is under-discussed, under-checked and underdiagnosed. We want to change that.”
“Our new AFib detection feature keeps closer watch on this high stroke risk condition during routine blood pressure monitoring, making AFib detection more widely accessible and more often practiced so we can help reduce the health risk,” said Kellogg.
As per DelveInsight’s “Blood Pressure Monitoring Devices – Market Insights, Competitive Landscape, and Market Forecast – 2030”, the global blood pressure monitoring devices market was valued at USD 1.04 billion in 2023, growing at a CAGR of 10.68% during the forecast period from 2024 to 2030 to reach USD 2.10 billion by 2030. The blood pressure monitoring devices market is witnessing positive growth owing to various factors such as the increasing prevalence of hypertension, the surge in the geriatric population, the increasing prevalence of cardiovascular disease, and technological advancements in product offerings. Therefore, the market for blood pressure monitoring devices is estimated to grow during the forecast period from 2024 to 2030.
Boston Scientific WATCHMAN FLX™ Left Atrial Appendage Closure Device Demonstrated Superior Bleeding Risk Reduction to Oral Anticoagulation Following a Cardiac Ablation in the OPTION Clinical Trial
On November 16, 2024, Boston Scientific Corporation announced positive three-year primary endpoint results from the OPTION global clinical trial of the WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device. The study compared the device to first-line oral anticoagulants (OAC), including 95% direct oral anticoagulants (DOAC) and 5% warfarin, for reducing stroke risk in patients with non-valvular atrial fibrillation post-cardiac ablation. These findings were presented during a late-breaking science session at the American Heart Association’s Scientific Sessions 2024.
The trial successfully achieved the primary safety endpoint, demonstrating that the WATCHMAN FLX device had a lower rate of non-procedural major bleeding or clinically relevant non-major bleeding at 36 months compared to OAC (8.5% vs. 18.1%; P<0.0001). It also met the primary efficacy endpoint, showing non-inferiority to OAC for all-cause death, stroke, or systemic embolism (5.4% vs. 5.8%; P<0.0001). Additionally, the device demonstrated non-inferiority for the secondary endpoint of combined procedural and non-procedural major bleeding (3.9% vs. 5.0%; P<0.0001).
“The OPTION trial data provide clinical evidence indicating that, among patients who have undergone an ablation, LAAC with the WATCHMAN FLX device is not only as safe, but superior to OAC therapy for reducing the risk of long-term bleeding events,” said Dr. Oussama Wazni, vice chairman of Cardiovascular Medicine and section head, Cardiac Electrophysiology, Cleveland Clinic, and principal investigator of the OPTION trial. “Notably, we found high rates of procedural success in patients who had a WATCHMAN FLX implant after an ablation, and of patient adherence to their prescribed medication regimen following the procedures, which likely reinforced positive outcomes such as the low rates of ischemic and hemorrhagic stroke within the trial population.”
The randomized, controlled OPTION trial included 1,600 patients enrolled across 114 sites in the United States, Europe, and Australia, and demonstrated high rates of procedural success. In the trial, approximately 60% of device patients had their WATCHMAN FLX implant 90-180 days following their ablation procedure. The other nearly 40% of the device patients had the two procedures performed concomitantly, with the WATCHMAN FLX implant taking place after the ablation.
“The OPTION trial is the first large, randomized trial to rigorously evaluate LAAC as a safe and effective stroke risk reduction treatment following a cardiac ablation in a head-to-head fashion against commonly used oral anticoagulants, including DOAC,” said Brad Sutton, M.D., chief medical officer, Atrial Fibrillation Solutions, Boston Scientific. “These positive primary outcomes mean that patients receiving the WATCHMAN FLX device were able to eliminate long-term medication use while maintaining stroke protection. With this data, we see potential to both expand the indication for the WATCHMAN FLX platform and ultimately elevate it to become a frontline therapy for patients receiving cardiac ablation for atrial fibrillation to reduce their risk of stroke.”
In addition to the OPTION trial, the WATCHMAN technology is being evaluated against DOAC as first-line therapy in lower-risk patients within the CHAMPION-AF randomized trial. The latest-generation WATCHMAN FLX™ Pro LAAC Device, which was approved in the United States in 2023, is similarly being studied in several clinical trials, including the SIMPLAAFY randomized controlled trial that is evaluating a single-drug alternative to dual anti-platelet therapy as a post-procedural regimen.
According to DelveInsight’s “Left Atrial Appendage Closure Devices – Market Insights, Competitive Landscape, and Market Forecast – 2030”, the global left atrial appendage closure device market was valued at USD 1,206.94 million in 2023, growing at a CAGR of 11.45% during the forecast period from 2024 to 2030 to reach USD 2,564.70 million by 2030. The demand for left atrial appendage closure devices is primarily being bolstered by the rising prevalence of cardiovascular disorders such as atrial fibrillation, ischemic strokes, and heart attacks. Additionally, increasing technological advancement in the domain of left atrial appendage closure, is another key factor that is contributing to the growth of the left atrial appendage closure market during the forecast period from 2024 to 2030.
Encora Therapeutics Successfully Completed ULTRE Clinical Trial Evaluating Novel Wrist-Worn Wearable for Essential Tremor
On November 18, 2024, Encora Therapeutics announced the successful completion of the ULTRE (Upper Limb Tremor Reduction in Essential Tremor) clinical trial. The study assessed the safety, tolerability, and effectiveness of Encora’s wrist-worn stimulation device for individuals with essential tremor (ET), a condition impacting the upper limbs of approximately 7.6 million Americans. Existing treatments for ET have often proven insufficient or poorly tolerated, highlighting the urgent need for innovative therapeutic solutions. The results mark a significant step forward in addressing this unmet clinical need.
The 47-patient ULTRE study was designed as a double-blind, randomized, sham-controlled, cross-over clinical trial, adhering to rigorous scientific standards. Two distinct vibrotactile stimulation paradigms—Pulsed and Continuous—were compared with an inactive sham control. Participants were required to meet stringent inclusion criteria, ensuring the study’s robustness and clinical relevance.
The trial’s primary endpoints focused on safety and tolerability, while secondary endpoints evaluated changes in motor function and daily task performance, offering a thorough assessment of the device’s impact.
Patients were assessed using relevant portions of validated clinical scales, including the Essential Tremor Rating Assessment Scale (TETRAS) and the Bain & Findley Activities of Daily Living (BF-ADL) scale. Tremor severity was evaluated by blinded, experienced video raters and through blinded patient self-assessment, providing comprehensive and objective data throughout the study.
“The ULTRE study design is exceptionally rigorous and uniquely suited for a therapeutic study of Essential Tremor,” said Dr. Rodger Elble, study investigator and research consultant.
“Enrollment in the Encora ULTRE study progressed rapidly, demonstrating a strong interest and unmet need for novel therapeutic modalities among people with Essential Tremor. The Encora device showed excellent safety and tolerability to date, increasing confidence and bringing this pioneering innovation a step closer while providing new hope to patients,” said Dr. Fatta B. Nahab, Principal Investigator of the study.
“The completion of the ULTRE trial with encouraging results is a significant milestone in our journey to develop innovative, non-invasive solutions for this underserved patient population,” said Daniel Carballo, CEO at Encora Therapeutics. “Results will be detailed in an upcoming publication.”
According to DelveInsight’s “Wearable Medical Devices – Market Insights, Competitive Landscape, and Market Forecast – 2030”, the global wearable medical devices market is estimated to grow at a CAGR of 13.67% during the forecast period from 2024 to 2030. The wearable medical devices market is witnessing positive growth primarily owing to the rising prevalence of various chronic diseases such as cardiovascular, diabetes, pain, and others. Further, the rising burden of the geriatric population prone to various chronic diseases across the globe, the increasing awareness about fitness & physical activity, the increasing regulatory approval for wearable medical devices across the globe along with the presence of key players will in turn surge the demand of wearable medical devices during the forecast period. Therefore, the market for wearable medical devices is expected to grow during the forecast period from 2024 to 2030.
