The Zepp Clarity Pixie has all the amazing features of its predecessor, the Zepp Clarity One, including the ability to tailor hearing experiences to unique requirements and tastes. The shell of the hearing aid is made of a robust yet lightweight titanium alloy, ensuring durability and lightness. It provides comfort, breathability, performance, and biocompatibility when combined with medical-grade silicone earplugs for an improved hearing experience. The Pixie has an IPX7 water-resistance rating and a useful “Find Device” feature.
Zepp Clarity Pixie is designed to smoothly blend into a user’s everyday routine, serving as a practically unseen companion that gently helps them through their day. Bluetooth® Low Energy (BLE) technology allows users to control Zepp Clarity Pixie from smartphones, tablets, or Amazfit wearables.
Additional features of Zepp Clarity Pixie include:
- Ultra-compact and lightweight design, weighing just 1.1 grams each with the tip
- 17-hour battery life, supplemented with a rechargeable case for extra power on the move
- Offers features like Adaptive Feedback Cancel, Wind Noise Reduction, and Layered* Noise Reduction to manage feedback and noise
- Simple and easy to use
- Smart Phone Call feature that automatically switches the hearing aid to a Phone program, reducing feedback for easier conversation
- Eight unique programs on the Zepp Clarity App, adjusting for treble, middle, bass, and noise filter for each program
- 2-year warranty
Stan Zhang, General Manager of the Zepp Clarity Business Unit said, “The FDA’s Over-the-Counter Hearing Aid Act signaled a monumental shift, impacting the accessibility and affordability of hearing aids.” Stan Zhang added, “We’re at the forefront of the OTC hearing aid market, leveraging cutting-edge technology and design to redefine optimal hearing health and destigmatize hearing aids. Underpinning our belief that hearing health is fundamental to overall wellness, we aim to embolden those with hearing loss to take control of their well-being, comfortably and confidently.”
As per DelveInsight’s “Hearing Aid Devices Market” report, the global hearing aid devices market was valued at USD 7.01 billion in 2022, growing at a CAGR of 5.47% during the forecast period from 2023 to 2028, to reach USD 9.61 billion by 2028. The rise in demand for hearing aid devices is predominantly attributed to the growing prevalence of hearing loss across the globe, coupled with the rising geriatric population. Moreover, an increase in exposure to high-frequency sounds leading to noise-induced hearing loss could also augment the hearing aid market. In addition, technological advancements, raising awareness, and government initiatives about hearing aid devices are likely to propel the global hearing aid devices market.
Neoss® Group launched a new wireless intraoral scanner, NeoScan™ 2000
On September 15, 2023, Neoss Group, a leading innovator in dental implant solutions launched NeoScan™ 2000, the fast and easy-to-use wireless intraoral scanner that offers dental practitioners the ultimate digital impression solution.
The launch of NeoScan™ 2000 follows the success of last year’s launch of the NeoScan™ 1000.
The NeoScan 2000 provides dental professionals with the optimum digital impression solution. Its wireless technology frees clinicians from the confines of cords, allowing them to move freely during scanning. This mobility allows for the effortless collection of even the most difficult proximal locations, resulting in comprehensive and exact digital impressions. Its long-distance connectivity ensures consistent and uninterrupted data transfer, removing the need for constant repositioning or signal dropouts.
Furthermore, Neoss Group said that the free cloud storage in their NeoConnect will be increased to 1 terabyte, which is equivalent to approximately 25,000 cases. This is now available to all NeoScan users. All NeoScans have free NeoPro software and NeoConnect cloud service upgrades to assist dental practitioners in experiencing seamless integration and maximizing the potential of their scanners without incurring additional fees.
According to DelveInsight’s “Intraoral Cameras Market” report, the global intraoral cameras market was valued at USD 1.62 billion in 2022, growing at a CAGR of 10.42% during the forecast period from 2023 to 2028, to reach USD 2.94 billion by 2028. An Intraoral camera is just one of the many dental innovations used in assessing and diagnosing oral health problems, and the increase in demand for intraoral cameras is primarily attributed to the increasing prevalence of dental or oral disorders. In addition, rising technological advancement in the product portfolio, rising awareness among the population to maintain proper oral hygiene, and growing strategic business activities among the key players for market expansion in the field, among others are some of the factors expected to bolster the global market for intraoral cameras in the forthcoming years.
Beacon Biosignals Received FDA Clearance for AI-Assisted Sleep Monitoring Device Dreem 3S
On September 15, 2023, Beacon Biosignals announced that the company had received the US Food and Drug Administration (FDA) 510(k) Clearance for its Dreem 3S.
Dreem 3S is an advanced wearable headband with integrated machine-learning algorithms to capture electroencephalogram (EEG) data from the brain to monitor sleep architecture and aid in the diagnosis of disturbed sleep.
FDA Clearance identifies it as equal to in-lab polysomnography for the assessment of sleep stages. The inexpensive device allows patients to participate in scientifically approved, EEG-based sleep monitoring at home, revealing fresh insights into sleep physiology.
The Dreem 3S medical device transforms the traditional sleep monitoring process where patients had to spend nights in sleep laboratories, or had to rely on less-precise surrogate measures of sleep activity via wrist actigraphy.
It is the first dry-EEG medical gadget of its sort, allowing for easy EEG data collecting at home and providing automatic sleep staging based on the American Academy of Sleep Medicine (AASM) categorization. Patients utilize the device on their own, from the comfort of their own homes.
The Dreem 3S has a 24-hour recording time, 6 electrodes, and an integrated accelerometer to track head movement and body position while optimizing continuous high-quality data capture. A clinical usability study found that the Dreem 3S is well-tolerated by users and generates clinical-grade data in the home.
“It is very important patients suffering from disturbed nighttime sleep be accurately monitored in their natural settings. This new solution makes that possible and has the potential to help further research and therapeutic interventions within the field,” commented Maurizio Fava MD, Psychiatrist-in-Chief at Massachusetts General Hospital and Beacon Scientific Advisory Board member.
Jacob Donoghue MD PhD, CEO and co-founder of Beacon Biosignals, emphasized the impact of the technology in clinical trials saying “Longitudinal EEG sleep data may be a powerful tool to gain clinical insight into a wide variety of neurological and psychiatric conditions. We are enabling high-fidelity, overnight brain activity to be efficiently collected in the patient’s home, opening new doors for clinical trial endpoints.”
Alexander Chan PhD, Beacon’s Vice President of Analytics and Machine Learning added, “The advanced machine learning algorithms of the Dreem 3S will be instrumental in reducing the human variability that is present within existing clinical workflows, allowing for more precise, accurate insights for driving forward therapy development for sleep and sleep-related disorders.”
According to DelveInsight’s “Sleep Tech Devices Market” report, the global sleep tech devices market was valued at USD 16,941.46 million in 2022, growing at a CAGR of 17.31% during the forecast period from 2023 to 2028 to reach USD 44,038.42 million by 2028. 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 2023-2028.
Tasso Received CE Mark Certification for Tasso+™, Latest Generation Whole Blood Collection Lancet Device
On September 19, 2023, Tasso, Inc., the leading provider of patient-centric clinical-grade blood collection solutions, received CE Mark certification for its Tasso+™ device, a convenient, virtually pain-free blood lancet that collects whole liquid blood samples.
A single-use blood-lancing tool called the Tasso+ is used to collect microliter capillary whole blood samples. Tasso+’s user-friendly interface and virtually painless remote blood sample collection increase user satisfaction and engagement.
For pharmaceutical companies, the device can be used with compatible collection tubes to quicken decentralized clinical trials, particularly for pharmacokinetic and biomarker research endpoints. Tasso+ makes it possible for underserved and understudied patient populations to take part in clinical trials by using a patient-centric collection process that removes barriers to care access. The Tasso+ device also enables healthcare organizations and doctors to determine a patient’s blood chemistry and increase access to care.
The CE Mark designation allows Tasso to offer its patient-centric, high-volume blood collection solution in the European Union (EU) market, which includes 28 member states, plus Iceland, Norway, and Lichtenstein.
Tasso already received the Class II 510(k) clearance from the U.S. Food and Drug Administration (FDA) in August 2022.
“This designation is an important milestone for Tasso, allowing us to build upon the success of our CE Marked Tasso-M20 device and continue to expand our commercial footprint and reduce healthcare access barriers in Europe, where demand increasingly grows for patient-centric solutions,” said Ben Casavant, PhD, CEO and co-founder of Tasso. Ben commented, “The Tasso+ CE Mark enables us to support the pharmaceutical industry, academic and government institutions on research and clinical initiatives, as well as accelerate access to remote testing and care for more patient populations. We are excited to expand our customer base in Europe.”
According to DelveInsight’s “Blood Collection Devices Market” report, the global blood collection devices market was valued at USD 6.23 billion in 2022, growing at a CAGR of 6.85% during the forecast period from 2023 to 2028 to reach USD 9.25 billion by 2028. The blood collection devices market is slated to witness prosperity owing to factors such as increase in diagnostic tests owing to the growing prevalence of infectious diseases such as COVID-19, malaria, and others, increasing awareness over health, rise in blood transfusion procedures, and the growing focus on improving the safety and usability of blood collection devices for end users are further expected to result in the appreciable revenue growth in the blood collection devices market during the forecast period (2023-2028).
Neuralink Opens Recruitment for First-in-human BCI Trial
On September 19, 2023, Neuralink, the Elon Musk-backed brain-computer interface (BCI) maker, announced that it had opened recruitment for The PRIME study, the first-in-human trial, assesses the effectiveness of the business’ fully implantable, wireless BCI and delivering surgical robot. It evaluated BCI’s initial functionality for allowing paralyzed people to operate external devices with their thoughts.
Neuralink states that individuals with quadriplegia brought on by an ALS or cervical spinal cord injury may be eligible.
The N1 brain implant from Neuralink is roughly the size of a coin. The implant is remotely rechargeable and travels with electrode-laced threads that penetrate further into the brain. Additionally, Neuralink has an R1 robot that can be programmed to insert the BCI system without damaging the vasculature. The business created its system so that a user could manage a computer or mobile device from any location.
R1 will surgically implant the N1’s threads during the experiment in a part of the brain that manages motion intention. Once implanted, N1 remains cosmetically undetectable while wirelessly recording and sending brain signals to an app. To enable users to control a computer cursor or keyboard using their thoughts, an app decodes movement intention.
Neuralink is conducting its PRIME study under FDA investigational device exemption, garnered in May of this year.
According to DelveInsight’s “Brain Implants Market” report, the global brain implants market was valued at USD 1.09 billion in 2022, growing at a CAGR of 6.07% during the forecast period from 2023 to 2028 to reach USD 1.55 billion by 2028. The demand for brain/cranial implants is primarily being boosted by the rising number of trauma cases, increasing prevalence of brain cancers, technological advancement in product development, and growing prevalence of brain aneurysms, among other factors.
Creative Medical Technology Holdings Received FDA Clearance to Initiate a Phase I/II Clinical Trial of StemSpine® using AlloStem™ (CELZ-201-DDT) for the Treatment of Chronic Lower Back Pain
On September 19, 2023, Creative Medical Technology Holdings, Inc., a biotechnology company focused on a regenerative approach to immunotherapy, endocrinology, urology, gynecology, and orthopedics, announced that the US Food and Drug Administration (FDA) has cleared the Company to proceed with a Phase I/II clinical trial of StemSpine® using AlloStem™ (“CELZ-201-DDT”).
The trial aims to evaluate the safety, efficacy, and tolerability of CELZ-201-DDT. Around 30 individuals with chronic lower back pain are going to be enrolled in the trial.
The Company’s patented allogenic (donor) cell line, AlloStemTM, is used in CELZ-201-DDT, a procedure that uses “off-the-shelf, ready-to-use” donor cells that are universal and proprietary. AlloStemTM is injected into the areas around the diseased disc(s) using an ultrasound-guided, non-surgical procedure, with the potential to improve the blood supply to the disc and lower back without subjecting the patient to radiation as with other cell-based procedures. Utilizing an original immunomodulatory formulation made from allogeneic perinatal cells, CELZ-201-DDT sets itself apart. These cells have shown promise in preliminary research for tissue repair and altering cytokine profiles.
“The FDA’s clearance allowing us to pursue this clinical trial is a milestone event for Creative Medical Technology and a validation of our commitment to developing and advancing novel regenerative therapeutics that can improve patient lives,” said Timothy Warbington, CEO of Creative Medical Technology. Timothy added, “An estimated 20% of Americans suffer from chronic lower back pain, with many of these individuals relying on opioids as the standard of care for relief. With an opioid crisis in the United States, we believe that CELZ-201-DDT is potentially a more effective, sustainable, and safer non-surgical pain management option compared to opioids, and we look forward to advancing these studies.”
Courtney Bartlett, Director of Clinical Development, said, “Chronic lower back pain is an increasing cause of disability globally.” Bartlett added, “This clinical trial sets the foundation to potentially help patients with a safer alternative therapy for chronic lower back pain as the procedure can be performed in the outpatient setting under direct ultrasound guidance, without any radiation exposure.”
According to DelveInsight’s “Cell Therapy Global Market Insights” report, the global cell therapy market is estimated to grow at a CAGR of 14.34% during the forecast period from 2023 to 2028. The demand for cell therapy is primarily being boosted by the rising incidence of oncological disorders such as blood cancer, and others, the surge in cases of critical limb ischemia (CLI), increasing R&D and investments for cell therapy, and growing advances in technologies employed for manipulation and administration of cell therapies among other factors are further contributing in the overall growth of the cell therapy market during the forecast period from 2023-2028.
