C2Dx Launched Next Generation Shaw Scalpel System 

On March 26, 2024, C2Dx, a privately-owned medical device company, announced the launch of its Next Generation Shaw Scalpel System. The Shaw Scalpel System has obtained 510(k) clearance from the FDA for the upgraded controller of its advanced surgical technology, the Shaw Scalpel System. Enhancing user experience across the board, The Shaw Scalpel System facilitates precise anatomical dissection and swift hemostasis with its exceptionally sharp scalpel blade. This results in a clear, dry surgical field, ensuring superior visualization for the safe dissection of nerves and crucial anatomical structures.

“The FDA clearance for the next generation of Shaw Scalpel System is the culmination of in-depth user feedback and extensive efforts from every team member,” said Ben Burnham, VP of Sales and Marketing. “This milestone not only validates the safety and effectiveness of our technology but also highlights our commitment to provide healthcare professionals with state-of-the-art tools to enhance patient outcomes.”

“This launch is a reflection of C2Dx’s dedication to advancing medical technology. We endeavor to introduce innovative solutions to the healthcare industry,” said Kevin McLeod, CEO and President.

“The next generation Shaw Scalpel System, with more than 40 years of clinical history, provides surgeons with the utmost precision, visualization, and control. This instrument minimizes blood loss for the patient, maximizes my surgical efficiency and preserves visibility (very little char) during dissection. It has a very limited radius of energy dispersion (like the bipolar cautery) which is essential for working in the crowded anatomy of the neck where there are so many important nerves, vessels, and other structures in close proximity,” said Dr. Donald B. Kamerer Jr.

As per DelveInsight’s Powered Surgical Instruments Market Report,” the global Powered Surgical Instruments Market was valued at USD 2.06 billion in 2023, growing at a CAGR of 4.26% during the forecast period from 2024 to 2030 to reach USD 2.65 billion by 2030. Factors such as the rising aging population resulting in the increasing prevalence of degenerative bone disorders and ophthalmic conditions, the rising number of brain cancers, the increasing number of trauma cases, and growth in product innovation are stimulating the growth of the powered surgical instruments market positively.

Texas Original Announced Opening of Sugar Land Location and Launch of New RSO Gummies 

On April 01, 2024, Texas Original, the premier medical cannabis provider in Texas, announced the inauguration of its latest prescription pickup spot in Sugar Land, Texas. The new site marks the company’s fourth establishment in the broader Houston region and the inaugural medical cannabis pickup location in Fort Bend County, which ranks as the 10th most populous county in the state.

Additionally, Texas Original also announced the launch of its latest offering: Pineapple Gummies, a THC-only product infused with Rick Simpson Oil (RSO), boasting a potency of 20 mg. Joining the company’s lineup alongside recently introduced Dark Chocolate Bites and RSO Tincture, Texas Original’s Pineapple Gummies stand out as among the state’s pioneering medical cannabis products. Notably, they are the first gummy product in Texas to feature RSO, a full-spectrum extract renowned for encompassing all cannabinoids, flavonoids, terpenes, proteins, and other potentially advantageous compounds of the cannabis plant, thereby potentially enhancing the therapeutic effects of THC.

“Texans from every corner of the state reach out to us asking for better access to medical cannabis. We view it as our mission—and our responsibility—to work within the confines of the state’s restrictions to expand access to life-changing cannabis medicine,” said Nico Richardson, CEO of Texas Original. “We’re grateful for the opportunity to provide improved access to thousands of patients in Fort Bend County and offer them a wider range of products to help treat symptoms associated with conditions like cancer and PTSD.”

According to DelveInsight’s Gummy Vitamins Market Report, the global gummy vitamins market size is estimated to grow at a significant CAGR during the forecast period from 2023 to 2028. The gummy vitamins market is slated to witness positive growth due to the increasingly sedentary lifestyle of people globally, improper diet, lack of exercise, rising awareness among people to lead a healthy lifestyle, along with the rising advancements in delivering quality and nutrient-rich gummy vitamins across the globe, resulting in appreciable revenue growth of the gummy vitamins market during the forecast period (2024-2030).

Abbott Received FDA clearance for Whole Blood Rapid Test to help with the Assessment of Concussion at Patient’s Bedside 

On April 01, 2024, the U.S. Food and Drug Administration (FDA) granted clearance for Abbott’s i-STAT TBI cartridge to utilize whole blood, enabling physicians to evaluate patients suspected of having a concussion directly at the bedside. This advancement facilitates the acquisition of lab-quality results within 15 minutes. Previously, tests aiding in traumatic brain injury (TBI) assessment were solely approved for use with plasma or serum, necessitating the dispatch of samples to a laboratory for processing and analysis.

The recent clearance will expand testing capabilities to various healthcare settings beyond hospital emergency departments, including urgent care clinics certified to conduct moderate complexity tests. This marks a significant stride toward a future where testing could be conducted outside conventional healthcare environments, such as on the sidelines of sporting events.

The whole blood test on a portable instrument aids clinicians in assessing patients aged 18 years and older who exhibit symptoms suggestive of mild traumatic brain injury (mTBI), commonly referred to as concussion. Test results serve to potentially eliminate the necessity for a CT scan of the head and contribute to identifying optimal next steps for patient care. Conducting the test with a whole blood sample allows for testing to occur in healthcare settings lacking a laboratory, thereby expediting the evaluation of head traumas.

“Emergency departments can be a busy place. It’s important to be able to triage patients quickly,” said Geoffrey Manley, M.D., PhD, Chief of Neurosurgery at Zuckerberg San Francisco General Hospital, Professor of Neurosurgery at the University of California San Francisco and contact principal investigator for the TRACK-TBI Network. “Historically, that process for suspected concussions was largely subjective. With the help of this whole blood test, we can quickly and objectively determine whether or not a patient needs a CT scan or additional evaluation, right at the point of care. It’s an incredibly helpful tool that advances the treatment of traumatic brain injury.” 

According to DelveInsight’s Traumatic Brain Injury Assessment Devices Market Report, the global Traumatic Brain Injury (TBI) assessment devices market was valued at USD 2.8 billion in 2023, growing at a CAGR of 8.57% during the forecast period from 2024 to 2030 to reach USD 4.57 billion by 2030. The Traumatic Brain Injury (TBI) assessment devices market is witnessing positive growth owing to various factors such as the increasing road traffic crash cases, increasing prevalence of TBI, rising geriatric population, and increasing regulatory approvals & launches of Traumatic Brain Injury (TBI) assessment devices. Therefore, the market for TBI assessment devices is estimated to grow at a significant CAGR during the forecast period from 2024 to 2030.

Medtronic Swings FDA Clearance for Latest TAVR Device 

On March 28, 2024, Medtronic announced that it received approval from the U.S. Food and Drug Administration (FDA) for its Evolut FX+ transcatheter aortic valve replacement (TAVR) system. The device developed by Medtronic is specially designed for the treatment of symptomatic severe aortic stenosis.

As per Medtronic, the Evolut FX+ system is designed to provide enhanced coronary access windows via a modified diamond-shaped frame design, which is four times larger than previous iterations.

Jeffrey Popma, chief medical officer for Medtronic’s structural heart and aortic business, said: “We are committed to consistently developing and advancing minimally invasive solutions for physicians to treat their patients with aortic stenosis.”

“This is reinforced by our continued innovation of the Evolut TAVR platform, which has delivered proven valve performance and durability to physicians and patients for years. The Evolut FX+ TAVR system was designed to facilitate coronary access across a diverse range of patient anatomies with no compromise to valve performance.”

According to DelveInsight’s Transcatheter Aortic Valve Replacement Devices Market Report, the global Transcatheter Aortic Valve Devices Market was valued at USD 3.23 billion in 2023, growing at a CAGR of 15.41% during the forecast period from 2024 to 2030 to reach USD 7.64 billion by 2030. The demand for transcatheter aortic valve replacement devices is primarily being boosted by the increasing prevalence of aortic stenosis disorder, rise in cardiovascular disorders, increasing demand for TAVR procedures, increasing prevalence of aortic regurgitation and the technological advancements about the transcatheter aortic valve replacement arena which are expected to increase in the product demand thereby contributing in the growth of the transcatheter aortic valve replacement devices market during the forecast period from 2024-2030.

Nexalin’s device Improved Symptoms of Mild Traumatic Brain Injury

On March 28, 2024, Nexalin Technology disclosed favorable data stemming from a clinical trial assessing its neurostimulation device in veteran patients afflicted with combat-related mild traumatic brain injury (mTBI).

In the randomized, double-blind, placebo-controlled trial, Nexalin Technology evaluated its Gen-2 transcranial alternating current dynamic frequency stimulation (tACS) against a sham treatment. Twenty-four veteran patients underwent twelve sessions of either active tACS or sham tACS over four weeks.

The data which was presented at a meeting of the US government’s Biomedical Advanced Research and Development Authority (BARDA), revealed that participants receiving tACS experienced a decrease in pain compared to those in the sham group. Additionally, the cohort receiving Nexalin’s treatment exhibited a reduction in post-concussive symptoms.

Nexalin’s CEO Mark White said: “We believe the data we have reported provides evidence of the potential clinical efficacy of our neurostimulation device on improving mental healthcare outcomes among patients affected with mTBI, without any significant adverse effects.”

White added: “We look forward to advancing the technology within the military and government agencies to bring hope to countless numbers of military and civilian patients impacted by these often-debilitating conditions in the United States and around the world.”

According to DelveInsight’s Neurostimulation Devices Market Report”, the global neurostimulation devices market was valued at USD 5.82 billion in 2023, growing at a CAGR of 11.77% during the forecast period from 2024 to 2030, to reach USD 11.34 billion by 2030. The demand for neurostimulation devices is primarily motivated by the increasing incidence of chronic neurological diseases, such as migraine and epilepsy, escalating product demand as add-on therapy, the prevalence of lifestyle diseases such as depression and chronic pain, the adoption of technologically advanced products, and rising geriatric population among others during the forecast period.

CYduct Diagnostics Announced Positive Study Results for Biomarker Combinations in the Assessment of Breast Cancer 

On April 02, 2024, CYduct Diagnostics, Inc., a precision medicine-oriented women’s health firm dedicated to advancing breast cancer risk assessment and diagnostic tools, announced encouraging findings from its recent research on breast cancer biomarkers.

In the pilot study employing liquid biopsy samples, the primary endpoint was successfully achieved by measuring concentrations of specific biomarkers, showcasing a noteworthy correlation in predicting breast health. This approach displayed a clinically meaningful enhancement compared to assessing a single biomarker alone. While comprehensive data results are currently restricted, a distinct positive trend has been discerned. Subsequent research endeavors will persist in enhancing the precision and predictive capacity of this breast health assessment platform.

“The study results showing a specific combination of biomarkers could represent a transformative medical advance for breast cancer risk assessment,” said Jill Dietz, M.D., CYduct’s chief medical officer. “We look forward to expanding our breast health products into the precision medicine risk assessment space and bringing this potentially game-changing new test option to women as quickly as possible.”

Dom Gatto, CEO of CYduct Diagnostics stated: “Biomarkers that assess breast cancer, predict breast cancer outcomes and influence treatment choices will play a major role in the future management of breast cancer. CYduct’s proposed combination of clinically established breast cancer biomarkers will foster the acceptance of precision medicine-based breast cancer risk assessment and screening programs by creating an individual risk profile, which is irrespective of breast density and interpretation.”

According to DelveInsight’s Breast Cancer Diagnostics Market Report”, the global Breast cancer diagnostics market was valued at USD 4.20 billion in 2023, growing at a CAGR of 6.67% during the forecast period from 2024 to 2030 to reach USD 6.16 billion by 2030. The Breast cancer diagnostics market is witnessing positive growth owing to factors such as the increasing prevalence of breast cancer, increasing age and sedentary lifestyle, technological advancements, and government initiatives to increase the rate of screening and diagnosis, thereby all factors contributing to the growth of Breast cancer diagnostics market during the forecast period from 2024-2030.