Johnson & Johnson, Launched New Intraocular Lens in EMEA Region

On February 15, 2024, Johnson & Johnson Medtech’s vision unit launched the Tecnis PureSee lens in the EMEA region. Tecnis PureSee is a purely refractive intraocular lens (IOL) specifically designed to correct presbyopia. Its proprietary design is intended to provide seamless, high-definition vision. Johnson & Johnson asserts that it surpasses monofocal IOLs with superior contrast and low-light performance, positioning it as a top choice in its category.

According to a news release, patients using contemporary lenses have to make trade-off judgments. While some lenses provide good vision without the need for glasses at all distances, they may also cause glares and halos. According to the company, Tecnis PureSee addresses these problems and enhances overall patient and surgeon outcomes.

Further, Johnson & Johnson stated that the Tecnis PureSee IOL offers surgeons ease of use while providing high tolerance to refractive error. It delivers continuous, high-definition vision, particularly excelling in distance and intermediate vision. The company states that its dysphotopsia profile is comparable to that of a monofocal IOL in terms of frequency, bother, and difficulty levels, resulting in minimal to no visual symptoms such as halos, glares, and starbursts.

“Cataract surgery is the number one surgery performed globally, with 28 million procedures each year. But only 10-15% of patients are getting advanced optical IOLs specifically designed for astigmatism and presbyopia,” said Jacqueline Henderson, president, of Vision, EMEA, Johnson & Johnson. Jacqueline added, “Today, we’re proud to launch the Tecnis PureSee IOL, giving surgeons and patients the choice of a premium IOL that combines clarity of vision and reduced visual symptoms.”

As per DelveInsight, the global intraocular lens market was valued at USD 3.85 billion in 2023, growing at a CAGR of 4.89% during the forecast period from 2024 to 2030 to reach USD 5.13 billion by 2030. The demand for intraocular lenses is witnessing a surge primarily due to the rising prevalence of eye diseases, increasing initiatives by various governments across the globe in controlling and treating blindness, technological advancements in IOLs, and the increasing geriatric population who are more susceptible to ocular ailments which are expected to contribute in the growing product demand thereby boosting the growth of the intraocular lens market in the upcoming years. 

Sparrow BioAcoustics Launched Software that Turns a Smartphone into a Stethoscope

On February 15, 2024, Sparrow BioAcoustics launched stethoscope software that allows a smartphone to be used as a stethoscope. With the use of the software, smartphones can be used as medical-grade stethoscopes. Users can gather, examine, and communicate vital information about heart health with medical professionals from any location. 

In June 2023, Sparrow received the FDA approval for the downloadable application. The FDA approval marked the debut of the initial FDA-cleared smartphone application for a stethoscope, classified as medical device software (SaMD). Additionally, it obtained another FDA clearance for consumer utilization, enabling individuals to play a proactive part in monitoring their heart health. 

Stethophone employs the integrated microphone of a smartphone to capture the intricate heart sounds. These sounds are then filtered using bioacoustics engineering to deliver precise, medical-grade diagnostic signals. The company is optimistic that its technology could facilitate earlier and more effortless detection and diagnosis of both common and complex cardiac conditions.

“We are at the forefront of a revolution in personalized heart health,” said Mark Attila Opauzsky, CEO of Sparrow BioAcoustics. Mark added, “Stethophone embodies our commitment to provide everyone the power, agency, and access to fight heart disease right in their own hands. Launching on Valentine’s Day symbolizes our dedication to heart health and the love and care we invest in our products and the people they serve.”

According to DelveInsight, the Stethoscope Market is estimated to grow at a CAGR of 5.3% during the forecast period from 2024 to 2030. The demand for stethoscopes is primarily being boosted by the increasing number of average patient visits to physicians owing to the rising prevalence of chronic diseases such as cardiovascular diseases, respiratory illnesses such as asthma, bronchitis, and lifestyle disorders such as hypertension, diabetes, obesity, and others. Further, the increasing geriatric population, the rising demand for an electronic stethoscope, various product approvals & launches, innovation in product development, and others are contributing to the overall growth of the stethoscope market in the upcoming years. 

Better Therapeutics Received FDA Breakthrough Nod for Liver Disease

On February 20, 2024, Better Therapeutics announced that the US Food and Drug Administration granted breakthrough device designation to its MASH treatment. The prescription digital therapeutic (PDT) provides innovative cognitive behavioral therapy (CBT) to treat adults diagnosed with metabolic dysfunction-associated steatohepatitis (MASH), previously recognized as NASH.

The innovative CBT approach focuses on modifying lifestyle behaviors recognized to either cause or exacerbate the advancement of metabolic diseases. The company designed its platform to bridge the existing gap in widely available and standardized intensive behavioral therapies, and effectively facilitate the adoption of established treatment guidelines emphasizing behavioral changes as fundamental to treatment. Last year, its AspyreRx PDT for type 2 diabetes received FDA clearance and was launched.

The company stated in a news release that, the breakthrough nod was granted based on the LivVita clinical study results. The trial effectively achieved its primary objective by decreasing liver fat levels within 90 days. Additionally, it reached significant secondary goals associated with enhanced liver health, with no adverse events related to the device reported.

“With breakthrough device designation in hand, we now have a pathway to accelerate the attainment of marketing authorization for a potential second indication and we are actively seeking strategic partnerships to expedite the development and commercialization of this therapy for the millions of patients with advanced liver disease,” said Frank Karbe, president and CEO at Better Therapeutics. Frank mentioned, “This also reinforces the potential for our therapeutics platform to broadly address metabolic disorders.”

According to DelveInsight, Digital Health Market was valued at USD 178.37 billion and is estimated to grow at a CAGR of 18.25% during the forecast period from 2024 to 2030 to reach USD 486.55 billion by 2030. The digital health market is observing remarkable market growth due to the growing awareness, adoption of digital healthcare, and the rising demand for IoT, AI, 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 in the upcoming years. 

X-trodes Received FDA 510(K) Clearance for Wearable “Skin” Solution

On February 20, 2024, X-trodes, a medical device company, engaged in bringing wireless monitoring to the home received the US Food and Drug Administration 510(k) clearance for X-trodes System M, a novel wireless wearable technology used for advanced electrophysiological monitoring. 

X-trodes’ Smart Skin consists of customizable dry-printed multi-modal electrode patches. These patches are capable of monitoring a diverse array of biopotential signals from any location on the body, enabling the acquisition of EEG (brain activity), EKG/ECG (cardiac monitoring), EOG (eye movement), and EMG (muscle activity) data. The discreet patches are simple to apply and comfortable to wear, without the need for gels, wires, or other uncomfortable solutions. 

The FDA approval for the device comes after a thorough scientific evaluation of the X-trodes system’s accuracy and consistency. According to the study, the EEG, EOG, EMG, and EKG/ECG signal measurements made with X-trodes technology are comparable to those made with clinical electrophysiology devices that have received FDA clearance.

“The X-trodes system is the next generation of wearable and fully wireless solutions, enabling clinicians and researchers to unleash the full potential of medical-grade electrophysiological monitoring,” said Ziv Peremen, Ph.D., CEO of X-trodes. Ziv commented, “Gaining FDA clearance affirms the value of this technology and its potential to improve health and wellness through access to real-time electrophysiological data. It will further shorten the path to commercialization for a range of clinical use cases.”

“Despite an abundance of legacy and new medical device companies entering the market, there is still no single configurable remote monitoring system capable of supporting neurology and cardiology departments in providing the best possible patient experience and outcomes,” said Dr. Deganit Barak Shinar, VP of clinical affairs at X-trodes. “Our medical-grade multi-modal solution, which can be deployed across clinical departments and outpatient settings, including the home, has the potential to significantly improve the provision of care.”

According to DelveInsight, the Patient Monitoring Devices Market was valued at USD 35.21 billion in 2023 and growing at a CAGR of 8.20% during the forecast period from 2024 to 2030; it is expected to reach USD 56.46 billion by 2030. The escalating demand for patient monitoring devices is primarily attributed to the increase in the prevalence of various chronic and lifestyle-associated disorders. Moreover, the sudden outbreak of the COVID-19 pandemic has also contributed to the patient monitoring devices market. Additionally, the growing preferences for remote patient monitoring systems among patients and healthcare providers, the increase in technological advancement in the product arena, and the rise in the approval of various patient monitoring devices in the current year, among others are also some of the factors responsible for potentially increasing the global patient monitoring devices market in the upcoming years. 

Lumicell Announced Initial Data Demonstrating LUMISIGHTTM’s Ability to Detect Metastasized to Multiple Organs in the Peritoneum

On February 20, 2024, Lumicell, Inc., a privately held company dedicated to pioneering fluorescence-guided imaging technologies for cancer surgery, disclosed encouraging preliminary findings from its ongoing feasibility study of the primary candidate, LUMISIGHT™. The study aims to detect peritoneal malignancies during surgical debulking. The current study employs the investigational LUMISIGHT optical imaging drug alongside its corresponding imaging device to differentiate tumor metastases to organs within the peritoneum. Initial findings from adult patients were presented in a podium session by James C. Cusack, Jr. MD, Associate Professor of Surgery at Massachusetts General Hospital, during the Advanced Cancer Therapies meeting hosted by the Society of Surgical Oncology.

Dr. Cusack said, “This data advances the potential for image-guided surgery to detect small tumors and metastases to organs in the peritoneal cavity which could provide better outcomes for our patients.” Dr. Cusack added, “Further innovation is desperately needed to improve the benefits of cytoreductive surgery for this invasive and elusive cancer. We look forward to continuing the clinical development program with Lumicell and advancing patient care.”

“We are highly encouraged by this initial data in a promising new indication, as we continue to expand the development of LUMISIGHT across the spectrum of solid tumors. Everything we do at Lumicell is focused on improving surgical outcomes for patients,” said Howard Hechler, President of Lumicell.

According to DelveInsight, the Diagnostic Imaging Equipment Market was valued at USD 24.15 billion in 2020, growing at a CAGR of 5.10% during the forecast period from 2024 to 2030, to reach USD 33.56 billion. The demand for Diagnostic Imaging Equipment is primarily attributed to the rising technological advancement, growing burden of chronic diseases, increasing patient awareness regarding early-stage diagnosis, growing demand for effective & efficient imaging technologies for diagnosis, and increasing geriatric population.

Konesksa Enrolled First Patient in Learns Observational Study to Remotely Measure Disease Progression Using Digital Biomarkers in Neurodegenerative Disorders

On February 20, 2024, Koneska announced that the first patient was enrolled in the LEARNS study. It is an observational study, which is being conducted to assess the reliability and responsiveness of digital biomarkers over time, utilizing mobile and wearable-based assessments. The objective is to enhance signal detection for potential disease-modifying therapies in neurodegenerative conditions, including Parkinson’s disease. 

The LEARNS study aims to employ digital biomarkers for remote measurement of disease progression, offering a patient-centered approach to capturing changes and impacts of the disease in daily life. Both the basket and disease progression components of the study are structured to gather data at various time points, enhancing convenience, lessening burdens on patients and clinics, and improving precision through repeated measures. By integrating both basket and disease progression components, the study seeks to reduce in-clinic demands while enabling participants to complete comprehensive assessments remotely.

“We’re excited to announce the enrollment of the first patient in our LEARNS study, which represents a major step forward in leveraging wearable and mobile device technology to advance our understanding and management of neurologic disorders and disturbed sleep,” said John Wagner, M.D., Ph.D., Chief Medical Officer, Koneksa. John commented further, “The data collected in the LEARNS study enables a more comprehensive picture of digital biomarkers in neurologic disorders, to inform future studies on the detection of prodromal disease, changes in disease state before clinical presentation, and progression of clinical symptoms.”

“The LEARNS study will use individual measures from Koneksa’s neuroscience toolkit, to capture both clinician ratings and patient-reported experiences. The study aims to address critical gaps in current knowledge in neurological disorders by harnessing the power of mobile EEG, wearable devices, and other advanced technologies to objectively measure sleep disturbances in real-world settings,” said Elena Izmailova, Ph.D., Chief Scientific Officer, Koneksa.

According to DelveInsight, the Digital Therapeutics Market is estimated to grow at a CAGR of 27.73% during the forecast period from 2024 to 2030. The demand for digital therapeutics is being boosted by the increasing prevalence of chronic diseases such as diabetes, mental illness, cancer, and heart failure (HF), advancements in technology such as the continuous advancements in mobile technology, wearable devices, artificial intelligence, machine learning, and data analytics have facilitated the development of more sophisticated and effective digital therapeutics solutions. Rising healthcare cost as healthcare costs have been steadily increasing in many countries. Digital therapeutics offer an opportunity to reduce healthcare expenses by providing remote and efficient healthcare delivery, reducing the need for frequent hospital visits, and preventing costly complications associated with chronic diseases. Regulatory support, growing acceptance among healthcare professionals, health insurance coverage, and strategic partnerships and investments among others are some of the major factors contributing to the overall growth of the digital therapeutics market and driving the market growth during the forecast period from 2024-2030.