TELA Bio Launched FDA-approved Hernia Mesh Fixation Devices 

On March 21, 2024, TELA Bio, Inc., a medical technology firm, launched its FDA-approved LIQUIFIX devices for hernia repairs in the United States. The LIQUIFIX FIX8™ and LIQUIFIX Precision™ are specifically engineered for laparoscopic and open femoral and inguinal hernia repairs, respectively.

These devices are the sole FDA-approved choices for securing mesh and bringing peritoneal tissue into proximity using liquid anchors. This method has the potential to diminish mechanical tissue damage by eliminating the need for penetrating tacks, sutures, or staples. By employing a non-penetrative technique, it enables accurate mesh fixation while minimizing the risk of complications.

Manufactured by Advanced Medical Solutions Limited, a U.K.-based company, the LIQUIFIX products have demonstrated robust performance in Europe and various other global markets for the past three years. TELA Bio’s partnership with AMS has facilitated the U.S. launch, capitalizing on TELA’s growing salesforce and dedication to innovative technologies.

The LIQUIFIX devices are intended for application with prosthetic polypropylene or polyester mesh. They are not recommended for patients with sensitivities to particular adhesives or dyes, nor for meshes composed of PTFE, or for specific types of tissue fixation.

As per DelveInsight’s “Hernia Repair Devices Market Report,” the global hernia repair devices market was valued at USD 4 billion in 2023, growing at a CAGR of 5.08% during the forecast period from 2024 to 2030 to reach USD 5.38 billion by 2030. The rise in demand for Hernia Repair Devices is primarily attributed to the rising incidence of hernia, growing surgeries for hernia treatment, technological advancement in the product portfolio, and favorable reimbursement scenarios, among others.

Stryker Completed Acquisition of SERF SAS 

On March 24, 2024, Stryker announced the acquisition of SERF SAS, a joint replacement company headquartered in France, from Menix.

With over 50 years of experience in the medical device industry, SERF SAS is renowned for its advancements in hip implants, notably the creation of the original Dual Mobility Cup. Stryker, in its acquisition announcement, highlighted that SERF SAS will enhance its current footprint in France and throughout Europe, in addition to bolstering its global joint replacement portfolio. This strategic move enables Stryker to cater to a broader spectrum of patients by fortifying its implant product offerings.

“The SERF SAS product portfolio is built on a trusted legacy within the orthopedic industry,” said Mathieu Badard, Vice President and General Manager, Stryker’s Joint Replacement division, Europe. “We are thrilled to combine our best-in-class product portfolios and work together to expand our presence within Europe and increase patient access to differentiated products for joint replacement.”

According to DelveInsight’s “Joint Reconstruction Devices Market Report”, the global Joint Reconstruction Devices Market was valued at USD 20.64 million in 2023, growing at a CAGR of 6.01% during the forecast period from 2024 to 2030, to reach USD 29.10 million by 2030. The Joint Reconstruction Devices market is expected to witness growth due to a rise in the prevalence of joint-related diseases such as arthritis, bone degenerative diseases, osteoporosis, gout, and injuries, growing technological advancements in product development, increasing awareness for minimally invasive procedures, and surge in the geriatric population.

FDA Issued 510(k) Clearance for RedDrop Dx’s Blood Collection Device 

On March 25, 2024, The US Food and Drug Administration (FDA) issued 510(k) clearance for RedDrop Dx’s RedDrop One blood collection device, allowing it for prescription use. 

RedDrop One is a pain-free, cost-effective, user-friendly system for collecting and dispensing whole blood and plasma. It’s engineered to simplify the process of gathering larger blood volumes, offering improved reliability and reducing discomfort for patients.

The device is customized to provide a blood collection process that is less painful for both patients and healthcare providers alike.

In a clinical trial involving 100 participants, the effectiveness of RedDrop One for self-collection of blood samples was demonstrated, achieving a 97% success rate among users who followed the device’s instructions.

RedDrop One is versatile and suitable for a variety of settings, including home health, point-of-care, centralized facilities, and remote clinical trial testing environments.

RedDrop Dx CEO and co-founder Kris Buchanan said: “Receiving FDA Class II medical device clearance for RedDrop One, our industry-leading solution, allows us to play a crucial role in improving patient care by making blood collection more accessible, reliable, less painful, and with the highest quality.

“This is particularly important for supporting decentralized clinical trials and a variety of testing applications, where our technology can help overcome common obstacles related to phlebotomy and ensure timely access to essential tests.

“Demand for RedDrop One has never been higher as the industry has become more aware of our breakthrough technology. We look forward to leading the industry and realising the potential of remote testing.”

According to DelveInsight’s “Blood Collection Devices Market Report”, the global blood collection devices market was valued at USD 6.23 billion in 2023, growing at a CAGR of 6.85% during the forecast period from 2024 to 2030 to reach USD 9.25 billion by 2030. The blood collection devices market is slated to witness prosperity owing to factors such as an increase in diagnostic tests owing to the growing prevalence of infectious diseases such as COVID-19, malaria, and others, increasing awareness over health, a 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 (2024-2030).

Next Generation Shaw Scalpel Received 510(k) Clearance, Ushering in a New Era of Surgical Precision 

On March 26, 2024, C2Dx, a privately-held medical device company, announced that it received 510(k) clearance from the FDA for its next-generation controller designed for the advanced surgical technology, The Shaw Scalpel System. Enhancing the user experience for all involved, The Shaw Scalpel System facilitates precise anatomical dissection and immediate hemostasis through its surgically sharp scalpel blade. This results in a dry, clean surgical field, ensuring exceptional visualization for the safe dissection of nerves and critical anatomy.

“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.

“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.

According to DelveInsight’s “Surgical Equipments Market Report”, the global surgical equipment market will grow at a CAGR of 7.87% during the forecast period from 2024 to 2030. The surgical equipment market is anticipated to witness prosperity owing to factors such as an increase in the number of surgeries that demand more surgical equipment in the market. Furthermore, advancement in product development over the last decade has fueled the market growth of the surgical equipment industry. An increase in the geriatric population is another factor that will result in appreciable revenue growth in the surgical equipment market during the forecast period (2024-2030).

LivaNova’s Sleep Apnoea Device Trial Achieved Positive Predictive Outcome 

On March 21, 2024, the medical technology company LivaNova announced positive predictive outcomes from its OSPREY clinical study evaluating the aura6000 hypoglossal nerve stimulator system for the treatment of obstructive sleep apnea (OSA).

The OSPREY study aimed to address obstructive sleep apnea through targeted hypoglossal nerve stimulation.

The prospective, multicentre, randomized, controlled, open-label trial evaluated the safety and effectiveness of the aura6000 system versus a no-stimulation control in moderate to severe OSA patients. It enrolled patients with OSA who were unable or not willing to use positive airway pressure treatment.

The primary efficacy endpoint of the trial is to demonstrate a higher apnea-hypopnea index (AHI) responder rate in subjects with activated device stimulation compared to subjects without stimulation after seven months of follow-up.

Upon completing the seven-month follow-up for the entire cohort, the company intends to submit the final clinical module of the OSPREY study to the FDA.

LivaNova CEO Vladimir Makatsaria said: “We are pleased to have achieved this positive milestone for the OSPREY study. In accordance with the study protocol, once the last patient implanted completes their final follow-up visit, we will conduct the final analysis for the study. Until then, we will continue to actively work with the clinical sites to manage the study patients.”

According to DelveInsight’s “Sleep Apnea Devices Market Report”, the global sleep apnea devices market was valued at USD 7.53 billion in 2023, growing at a CAGR of 6.26% during the forecast period from 2024 to 2030 to reach USD 10.82 billion by 2030. The demand for sleep apnea devices is primarily being boosted due to the increasing cases of sleep apnea, and the rising population with obesity. Further, the rising adoption of advanced and innovative technologies, the rising awareness about sleep apnea devices, the increasing geriatric population, and the increasing product launches and approval among others, thereby contribute to the overall growth of the sleep apnea devices market during the forecast period from 2024-2030.

Landmark Non-inferiority Clinical Trial Demonstrated Nanodropper’s Positive Impact on Glaucoma Treatment

On March 21, 2024, Nanodropper, Inc., an ophthalmic device company known for developing the eyedrop volume-reducing Nanodropper® Adaptor, announced the publication of its clinical trial titled “An Evaluation of the Efficacy and Safety of Timolol Maleate 0.5% Microdrops Administered with the Nanodropper” in the journal Ophthalmology.

The trial recruited patients with glaucoma and revealed that there was no clinically significant variance in the intraocular pressure (IOP)-lowering effects between micro drops administered with the Nanodropper Adaptor and conventional eyedrops of timolol, a commonly used medication for glaucoma treatment. This similarity was observed consistently across all time points throughout the eight-hour study duration. Additionally, participants in the micro drops group experienced a notably smaller reduction in heart rate compared to those receiving conventional drops. This finding suggests a potentially improved safety profile associated with the use of micro drops of timolol compared to conventionally-sized eyedrops.

“We are thrilled, albeit not surprised, by these encouraging results demonstrating the Nanodropper Adaptor’s capacity to improve patient safety,” said Jenny Steger, PhD, Chief Scientific Officer of Nanodropper. “Thousands of eyecare clinics in the U.S., and tens of thousands of patients worldwide, are already utilizing the Nanodropper to great effect. This study reflects the benefits these patients have been experiencing.”

“Eyedrop size has not seriously been commercially addressed in the past,” said Alan L. Robin, MD, corresponding author on the publication and a global leader in glaucoma research and treatment for decades. He is a charter member of the American Glaucoma Society, its first executive vice president, and sits on Nanodropper’s Medical Advisory Board. His previous research on microvolume delivery of eyedrops directly inspired the creation of the Nanodropper Adaptor.

“I believe microvolume delivery technologies may offer solutions in the form of less waste, increased patient savings, and hopefully better safety profiles for many topical ophthalmic medications,” said Dr. Robin. “Nanodropper is the first commercially available potential solution to this long-standing problem.”

According to DelveInsight’s “Ophthalmic Devices Market Report”, the global Ophthalmic Devices Market was valued at USD 55.91 billion in 2023, growing at a CAGR of 4.12% during the forecast period from 2024 to 2030 to reach USD 71.23 billion by 2030. The demand for ophthalmic devices is primarily being boosted by the rising prevalence of myopia and the growing geriatric population base which has resulted in the increased prevalence of ocular diseases of different etiologies, increasing number of ophthalmic surgeries, and technical innovation in product development which are expected to increase in the product demand thereby contributing in the growth of the ophthalmic devices market during the forecast period from 2024-2030.