eCential Robotics Receives FDA Clearance for its Surgical Robotic Platform for Spine Surgery

The FDA has approved a robotic spinal surgery platform designed to assist human surgeons by automating several steps of spinal procedures. The platform, developed by eCential Robotics, combines intraoperative 2D and 3D imaging, navigation, and robotics to create the surgical assistant. The design includes three mobile units that are linked together: a mobile viewing workstation, a mobile C-arm, and the mobile collaborative robot itself. All devices are linked to a single user interface, allowing the user to control imaging, navigation, and robotic functions from a single place.

The system is also fully open, which means it can be used with any implant manufacturer’s implants and can be tailored to specific surgical needs, with users able to create Apps within the software for a variety of applications such as cranial, orthopedics, and sports medicine. The platform is designed to assist, rather than replace, surgeons, and eCential says it hopes to “reinforce the safety and accuracy of surgical procedures” and see robotic assistants become the norm in routine operations one day.

The FDA approval also marks eCential’s entry into the US market, as the company previously only operated in Europe. Since its inception in 2009, eCential has sold 10 units of its platform and performed over 2,000 surgeries, with plans to expand into the United States.

“The FDA clearance of the eCential Robotics unified platform recognises our product’s dependability and robustness,” said Laurence Chabanas, CEO of eCential Robotics’ USA branch. He further added, it also fuels our desire to expand our presence in the United States. This is critical to our strategy. We are excited about these daring new and disruptive technologies, as well as the role eCential Robotics can play in reshaping bone surgical procedures and improving patients’ quality of life.

The global Surgical Robotic Systems market was valued at USD 5.02 billion in 2021 and growing at a CAGR of 11.50% during the forecast period (2022 to 2027); it is expected to reach USD 9.64 billion by 2027. As per DelveInsight analysis, the demand for surgical robotic systems is increasing due to an increase in surgical procedures, which can be attributed to a variety of factors such as an increasing geriatric population, who make up a large portion of the at-risk population for prostate cancer, valvular diseases, endometriosis, and other diseases, a growing need for robot-assisted surgery systems due to a growing inclination toward minimally invasive surgical approaches, and innovation in product development.

Baxter Gets 510(k) Clearance for Syringe Pump, Spurring Optimism of Faster FDA Review Process

Baxter International Inc., a leader in innovative medication delivery technology, announced the FDA 510(k) clearance of its new Novum IQ syringe infusion pump (SYR) with Dose IQ Safety Software, representing Baxter’s most recent developments for infusion therapy. Through Baxter’s IQ Enterprise Connectivity Suite, the Novum IQ SYR can fully integrate with hospital electronic medical records (EMRs).

Syringe infusion pumps are commonly used in pediatric, neonatal, and anaesthesia care settings to precisely deliver small amounts of fluid at low rates. The Novum IQ SYR provides a technologically integrated user experience that includes enhanced safety features, advanced connectivity, configurable anaesthesia care settings, and a strong portfolio of sets designed to help deliver optimum accuracy. Colored visual banners that clearly identify enteral delivery, a backlit keypad, and guided syringe loading are among the features of its user interface.

“We are thrilled to bring a new syringe infusion pump to the market that represents the next generation of Baxter’s intelligent infusion ecosystem,” said Heather Knight, president, Medication Delivery, Acute Therapies, Clinical Nutrition, Latin America and Canada. “Together, the Novum IQ syringe infusion pump, Dose IQ Safety Software and IQ Enterprise Connectivity Suite advance the interoperability and data insights needed to help prevent harm and personalize therapy for patients, including neonates and other fragile patients.”

As per DelvInsight’s latest assessment report on the “Infusion Pumps Market, the global infusion pumps market is expected to surge at a CAGR of 9.54% to reach USD 23.85 billion by 2027. The increasing prevalence of chronic diseases, increased demand for remote patient monitoring, growing research and development activities to launch home infusion systems, and rising costs of hospital-based infusion therapies are driving demand for infusion pumps.

Henry Schein Acquires Midway Dental Supply

Henry Schein announced the procurement of Midway Dental Supply, a full-service dental distributor serving dental office laboratories across the Midwestern United States. Henry Schein acquired 100% of Midway Dental. The transaction is predicted to be modestly dilutive to Henry Schein’s earnings per share in the fiscal year 2022 and increasingly accretive. The financial terms and conditions weren’t revealed.

Midway Dental’s sales were approximately $110 million in 2021, including roughly $20 million in sales of personal protective equipment and COVID-19-related products. Midway Dental offers a complete portfolio of consumable merchandise, services, equipment, and education products to around 7,000 customers, which will be immediately consolidated into Henry Schein’s United States Dental business. The incorporation of Midway Dental’s sales and service team with Henry Schein’s network of trusted advisors will further lead the Company’s efforts to offer customized solutions, technology-driven products, and services to help our dental customers meet the needs of the patients.

“Over the past 35 years, Midway Dental has earned an excellent reputation in the industry, grounded by a responsibility to provide customer service and industry leadership that is aligned with Henry Schein’s values-based culture and high-touch, full-service business model,” added Stanley M. Bergman, Chairman, Henry Schein. “Midway Dental’s vision to establish a nationwide footprint aligns with Henry Schein’s commitment to offer the products and services to customers can rely on to work more efficiently and deliver high-quality patient care.”

Magnus Medical’s SAINT Neuromodulation System Secures FDA 510(k) Clearance

Magnus Medical has announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its SAINTTM Neuromodulation System for the treatment of the major depressive disorder (MDD). The Neuromodulation System is intended for adults who have failed to achieve satisfactory improvement from prior antidepressant medications in the current episode. Magnus Medical is a privately held medical device company and one of the leading players in the Neuromodulation System Market. Magnus is working on brain stimulation technology to treat neuropsychiatric disorders.

SAINT Neuromodulation System combines advanced imaging technologies, personalized targeting, and new stimulation patterns. This combination is expected to yield a new form of individualized neurostimulation for people with treatment-resistant depression. Due to its potential to potential to provide more effective treatment for life-threatening or debilitating conditions than previous therapies and benign a novel innovation intended to create a positive impact on the treatment of severe depression, the FDA, in November 2021, granted the Breakthrough Device Designation to the SAINT Neuromodulation System. 

Major depressive disorder is considered to be a highly prevalent psychiatric disorder. As per the WHO, major depressive disorder affects 322 million people globally, representing an 18.4% increase in the number of people living with major depressive disorder between 2005 and 2015. As per the DelveInsight analysis, the global Neuromodulation Devices Market was valued at USD 5.71 billion in 2021 and growing at a CAGR of 8.95% during the forecast period from 2022 to 2027, it is expected to reach USD 9.56 billion by 2027. The Neuromodulation Devices Market is anticipated to register immense growth in the coming years owing to the increasing prevalence of neurological disorders coupled with the rising aging population, technological advancement in the product portfolio, and rising government initiatives to raise awareness among patients regarding neurological disorders. 

Medical Microinstruments Launches New NanoWrist Instruments for Surgical Robot

Medical Microinstruments, Inc. (MMI) has announced the launch of its new Supermicro NanoWrist® instruments for use with the Symani® Surgical System. The instruments is designed specifically to address the challenges of microsurgery.

Founded in 2015 near Pisa, Italy, Medical Microinstruments is a robotics company committed to enhancing the clinical outcomes for patients and enabling surgeons to achieve better outcomes in microsurgery.

MMI’s Supermicro NanoWrist instruments are commercially available in the European Union (EU). The tips of the new instruments are even smaller and more refined and are half the width of MMI’s standard microinstruments with a tapered design. The new supermicro needle holder and dilator were recently used in clinical procedures in Zürich, Florence, and Salzburg, with successful patient outcomes. As per Mark Toland, CEO of MMI, “the launch of the supermicro instruments is expected to enhance the capability of the robotic systems to address even smaller vessels that few surgeons can connect by hand.