MEDIT Announces Launch of i700 Intraoral Scanner 

On April 20, 2022, based on the success of i700 intraoral scanner, MEDIT Corp launched the all new i700 wireless intraoral scanner is light, fast, accurate, and now – wire-free.

i700 wireless is a lightweight, wire-free device that offers a smooth and quick scanning experience utilizing mm wave-based next-generation wireless communication technology. One battery offers 1 hour of continuous scanning and 8 hours in standby mode. The super-fast camera is capable of capturing up to 70 frames per second, collecting more data with each pass in realistic color and crisp images. 

The updated design boasts a reversible tip and wider scanning area allowing for easy, comfortable scanning at any angle with no constraints to movement. Keeping COVID-19 concerns in mind, the device is equipped with a convenient remote control button enabling clinicians to check scanned data from the scanner, and show patients, without worry of cross-contamination. 

The i700 wireless intraoral scanner is also laced with a self-disinfecting UV-C LED further keeps the unit clean. The i700 wireless runs on MEDIT Link, MEDIT’s software featuring integration with various other CAD/CAM providers as well as MEDIT’s own popular apps including Medit Design, Smile Design, Ortho Simulation, Model Builder, Crown Fit, and more.

GB Ko, CEO of MEDIT mentioned, “Our i700 wireless model is a game-changer with its effortless, wire-free capabilities and powerful, long-lasting battery.” 

As per DelveInsight analysis, the plethora of features being offered in one device and the wireless capabilities would further improve the process of care for clinicians.  According to DelveInsight’s “Intraoral Cameras Market” report, the global intraoral cameras market was valued at USD 1.47 billion in 2020, growing at a CAGR of 10.42% during the forecast period from 2021 to 2026, in order to reach USD 2.66 billion by 2026. 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.

Fresenius Medical Care receives FDA clearance for Versi™PD Cycler System

On April 21, 2022, Fresenius Medical Care received the 510 (k) clearance by the US Food and Drug Administration (FDA) for their Versi™PD Cycler System. It is a next-generation portable automated peritoneal dialysis (APD) system. VersiPD is the smallest, lightest, and quietest dialysis cycler in the United States. 

VersiPD is quiet, simple, portable, advanced, and is designed to improve health equity by making home therapy a more feasible option for a broader population of dialysis patients. The system is designed to allow patients to enjoy restful sleep through its nearly silent operation, less number of disruptive alarms, and it is also equipped with a night mode. The cycler is equipped with more personalized prescription programming to meet the individual needs of a wide range of patients. VersiPD comes with a large, intuitively designed touchscreen, as well as embedded videos with audio guidance to assist patients step by step through setup and treatment. The cycler battery and custom cart facilitate mobility around the home which can further improve a patient’s quality of life.

The peritoneal dialysis system is also supported by the Kinexus™ Therapy Management Platform which is a connected health system that aims to improve patient outcomes and nurse productivity through remote therapy monitoring and programming capabilities.

Joe Turk, President of FMCNA’s Renal Therapies Group, Alcon mentioned, “The clearance of VersiPD is another important step in our effort to make home therapies easier for patients and more efficient for clinicians.” 

Dr. Mike Anger, Chief Medical Officer for FMCNA’s Renal Therapies Group, said, “We believe that our new VersiPD will empower more patients to reclaim their freedom and independence, while further enabling care teams to better support patients and intervene more quickly when necessary”. He further added, “We know most patients can be successful dialyzing at home with the right technology and support, and this new cycler is an important milestone in our journey to truly transform dialysis care.”

VersiPD is expected to be available in the markets in a limited rollout in 2022 with more widespread availability planned in 2023 and beyond.

As per DelveInsight analysis, the entry of such devices would help in better management of kidney failure and provide patients a viable option of being treated at home thereby boosting the demand for home care products as well.  According to DelveInsight’s “Peritoneal Dialysis Equipment Market” report, the global Peritoneal Dialysis Equipment market was valued at USD 4.12 billion in 2020, growing at a CAGR of 5.89 % during the forecast period from 2021 to 2026, to reach USD 5.81 billion by 2026. The increase in demand for Peritoneal Dialysis Equipment is primarily attributed to the increasing prevalence of kidney disorders such as end-stage kidney disorder, kidney failure, and others. In addition constantly increasing old population, high blood pressure, and high diabetes prevalence is also driving factor for peritoneal dialysis equipment as old age and diabetic people are more likely to develop kidney disorders. Moreover, technological advancement in the peritoneal dialysis product pipeline and an increase in product approvals are among the other factors responsible for the global peritoneal dialysis equipment market.

Franklin Mountain Medical Receives US FDA Approval for New Dual Lumen Catheter for Cardiac Applications

On April 25, 2022, Franklin Mountain Medical announced today that the company has received FDA clearance of its patented UltraNav Transseptal Catheter System for controlled access and delivery of cardiovascular catheters and guidewires to the heart chambers via transseptal puncture.

The UltraNav device is a dual-lumen catheter that enables side-by-side, simultaneous delivery of both transseptal needles or catheters and intracardiac echocardiography (ICE) catheters through one dual-lumen device. The catheters are fixed in position together. This allows the ultrasound beam to lie in the same plane as the transseptal catheter and provides precise and complete visualization of catheter orientation, needle length, and needle tip location relative to the cardiac structure. The images provided by this devices are highly accurate as they are not distorted by the patient’s cardiac or respiratory cycle. These features enhance the clinician’s ability to visualize needle depth and orientation for precise and accurate delivery. Furthermore, the UltraNav catheter is designed in such a way that it can deliver a variety of ICE catheters from the right to left chambers of the heart. Finally, the UltraNav system is designed to eliminate the current practice’s need, cost, and scheduling complexities. 

The UltraNav Transseptal System is designed to deal with challenges that arise in current transseptal practices which require the placement of an ICE catheter into the heart or esophagus to display ultrasound images. 

Dr. Nabil Dib mentioned, “The complete, continuous visualization and delivery of catheters will result in more precise punctures and easier catheter navigation, which should improve the safety and performance of septal puncture and structural procedures. Compared to current practice, this will reduce scheduling complexity, reduce procedure cost and shorten overall procedure times. It should also provide the option of conscious sedation over general anesthesia when appropriate. I am very excited about the impact the UltraNav System can have on transseptal procedures.” 

According to DelveInsight analysis, the approval of such devices would further help in navigating the cardiac anatomy in a precise manner and conduct procedures such as transespetal procedures in a more accurate and precise manner delivering appreciable outcomes for patients. According to DelveInsight’s Interventional Cardiology Devices Market” report, the global interventional cardiology devices was valued at USD 13.21 billion in 2021, growing at a CAGR of 6.53% during the forecast period from 2022 to 2027, to reach USD 19.31 billion by 2027. The demand for interventional cardiology devices is primarily being boosted by the growing prevalence of cardiovascular diseases (CVDs) in the rising geriatric population, technological advancements in product development, the increasing adoption rates of minimally invasive surgeries, and increasing awareness programs regarding cardiovascular diseases. However, the availability of alternative treatments and product recalls are the major factors that are expected to restrain the growth of the interventional cardiology devices market during the forecast period.

Bioretec’s Bioresorbable Implant Reported to Provide Excellent Clinical Outcome in Pediatric Wrist Fracture Treatment

On April 25, 2022, it was reported in a published clinical study (Varga et al. BMC  was published in BMC Musculoskeletal Disorders) that confirmed the significant benefits of Bioretec‘s bioresorbable ActivaPin™ implants for pediatric patients in the treatment of severely displaced forearm and distal radius fractures. The results of the retrospective multicenter study indicate that patients treated with bioresorbable ActivaPin™ had significantly lower level of complications than those treated with traditional non-biodegradable metallic Kirschner-wires (K-wires) and no second surgical intervention was required.

Distal radius fractures are very common in pediatric patients, and severely displaced fractures may require surgical intervention. The current best practice surgical method is percutaneous K-wire osteosynthesis followed by immobilization. However, the non-biodegradable metal implants mostly require removal surgery that can cause further complications. The ActivaPin™ implant is made of bioresorbable polymer (PLGA), which safely disappears in the body in approximately two years. 

In the study, a total of 94 patients were reviewed in three pediatric trauma centers. The patients underwent operations due to severely displaced distal forearm radial fractures and were treated with either K-wire or with bioresorbable ActivaPin™. The study groups were examined for the number of minor and major complications as well as the need for repeated interventions. The complication rate of the ActivaPin™ group was reported to be significantly lower than of the K-wire group, and there were no major complications associated with ActivaPin™. In addition, no signs of growth disturbance were found in any of the children after long-term 18 months follow-up of the injury.

Timo Lehtonen, CEO of Bioretec, stated, “The results of the study are very encouraging. The novel surgical technique leads to less complications and also offers major advantages to surgeons. The benefits of ActivaPin™ were most pronounced in the first six weeks after surgery: the number of outpatient visits were reduced, and children’s sense of comfort was increased. In addition, avoiding second surgical intervention results in significant cost savings. And most importantly, children can return to their normal everyday life and activities faster.” 

The ActivaPin™ has been available in the market since 2008, and the product is currently used in over 30 countries. 

According to DelveInsight’s Trauma Fixation Devices Market” report, the global trauma fixation devices market was valued at USD 7.03 billion in 2021, growing at a CAGR of 6.42% during the forecast period from 2022 to 2027 to reach USD 10.21 billion by 2027. Factors such as the rising demand for technologically advanced products, increasing geriatric population, rising number of accident and trauma cases, growing prevalence of degenerative bone disorders, and the rising number of sports-related injuries are expected to drive the trauma fixation devices market. 

Phantom Neuro and Blackrock Neurotech Partner to Develop Next-Generation Assistive Devices

On April 26, 2022, Blackrock Neurotech, an industry leader in brain-computer interface (BCI) technology, and Phantom Neuro, a recently launched neurotech startup that delivers a high accuracy system for lifelike control of robotic orthopedic technologies, announced a cutting-edge alliance for the development of Phantom Neuro’s patent-pending Phantom X system. This system offers patients highly accurate, nearly real-time control of current and next-generation assistive devices, including prosthetics and exoskeletons. Blackrock’s engagement, coupled with its contribution to Phantom Neuro’s recent financing announcement, will help accelerate Phantom X’s research and development path to clinical trials. 

The Phantom X system offers intuitive prosthetic control via small, low risk, flexible sensors that are implanted under the skin within an amputation stump or injured limb. These sensors are capable of detecting muscle signals as the muscles contract, based on an individual’s intended movements. The electrical activity is sent wirelessly out of the body and decoded into those intended movements that are then enacted within a robotic mechanism, creating near-lifelike control of the assistive device, whether that is a prosthetic recreating a missing limb or an exoskeleton helping a person walk. 

Dr. Connor Glass, Founder and CEO of Phantom Neuro and primary inventor of Phantom’s technology, said, “Our technology will offer patients control of advanced prosthetics and exoskeletons in much the same way they control an intact limb. This can restore their quality of life to a degree that is currently not possible with existing solutions.”

Beyond Blackrock’s participation in Phantom Neuro’s recent round of funding, this R&D partnership would also help Phantom leverage Blackrock’s decades of experience in neurotechnology and the development of biocompatible implantable sensors to complement and bolster the Phantom X platform. 

According to DelveInsight’s Medical Exoskeletons Market” report, the global medical exoskeletons market was valued at USD 250 million in 2020, growing at a CAGR of 18.23% during the forecast period from 2021 to 2026 to reach USD 682.35 million by 2026. The demand for medical exoskeletons is primarily being boosted by the increasing prevalence of neurological disorders, rising prevalence of spinal cord injury, increasing number of brain injuries, and technological advancements in product development pertaining to medical exoskeletons contributing to the overall growth of the medical exoskeletons market during the forecast period from 2021-2026.

Vectorious Begins the VECTOR-HF II Study of its Implantable In-Heart Sensor for Left Atrial Pressure-Guided Patient Self-Management of Heart Failure

On April 26, 2022, Vectorius Medical Technologies Ltd announced the enrollment of the first six patients in the VECTOR-HF II Study, which will evaluate the V-LAP System’s novel approach of patient self-management for detecting and managing heart failure (HF) early in order to to avoid further damage to the heart.

The study includes New York Heart Association (NYHA) class II and III HF patients who will be implanted with the V-LAP in-heart implantable sensor. Direct pressure readings from the left atrium (LA), captured by the V-LAP sensor, will be visible to both physicians and patients using dedicated apps for the patient and for the clinic.

Remote access to pressure data generated from the LA, the most specific and comprehensive indication for fluid accumulation, enables physicians to provide early, personalized, and more accurate treatment to heart failure patients while also accounting for other comorbidities inside and outside the heart.

The V-LAP System is also equipped with features that engage patients as active participants in managing their disease. Using the V-LAP System, they will have an opportunity to obtain a real-time understanding of the correlation between their daily medication routine and activities, and the pressure of their left atrium. In events where the LA pressure may be out of the optimal range, patients would be guided to adjust diuretics based on the predefined treatment plan. If the LA pressure is in suboptimal ranges, the medical team is notified and can provide additional instructions to prevent further deterioration.

 VECTOR-HF II is a prospective, multi-center, single-arm study that was launched in Europe in January 2022, with plans to enroll 20 patients. In November 2021, the company completed its successful VECTOR-HF I study, which included 30 patients. Lessons learned from VECTOR-HF II will be incorporated into VECTOR-HF III, a larger pivotal study which is scheduled to begin in the US in 2023 with the goal of achieving FDA approval.

Eyal Orion, MD, Vectroius CEO, said, “The V-LAP System is the first wireless digital platform that enables chronic HF patients to manage their disease by titrating the dosing of their medication directly in response to accurate, very early detection of fluid accumulation.” He further added, “The successful completion of the VECTOR-HF I study and the launch of the VECTOR-HF II study are exciting milestones for Vectorious and for patients suffering from severe, chronic HF, and the culmination of more than a decade of development work required to enable placing a digital sensor directly in the heart. We strongly believe that the unique data from the heart’s LA, coupled with our technological platform, which enables millions of HF patients to take ownership of their disease, is the right and only way to transform treatment paradigm.”

According to DelveInsight’s Congestive Heart Failure Treatment Devices Market” report, the global congestive heart failure treatment devices market was valued at USD 17.41 billion in 2021, growing at a CAGR of 8.26% during the forecast period from 2022 to 2027 to reach USD 27.96 billion by 2027. The congestive heart failure treatment devices market is witnessing positive growth owing to the rising incidence of cardiovascular diseases (CVDs), a surge in the research and development activities in product development, and increasing incidences of the aging population who are susceptible to these diseases. Moreover, due to sedentary lifestyle and extreme benefits of these devices in heart failure cases during the COVID-19 pandemic and the growing popularity of minimally invasive interventions had further pushed the demand for these devices, thereby contributing to the growth of the congestive heart failure treatment devices market during the forecast period from 2022-2027.