GE HealthCare’s CARESCAPE Canvas Patient Monitoring Platform Received FDA Clearance 

On April 20, 2023, GE HealthCare, a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, received the US FDA 510(k) clearance for its CARESCAPE Canvas patient monitoring platform for precise and flexible patient care.

CARESCAPE Canvas and CARESCAPE ONE are components of a flexible ecosystem that can easily scale monitoring capabilities up or down depending on the acuity of each patient. These products are provided on a standardized platform that promotes enterprise efficiency and customer convenience.

Patients at all degrees of acuity can use CARESCAPE Canvas, a FlexAcutity solution with smart parameter technology. By utilizing micro modules that link with standardized medical USB technology, this monitoring platform offers flexibility, standardization, and convenience of use. Also, by adding or removing cables with different configurations, more effective care may be provided based on the patient’s needs. Additionally, it has replaceable frames for advanced parameters and flexible, simple-to-configure software that make it possible to easily redeploy monitoring devices around the hospital enterprise as needed.  

“As patient acuity and disease trends change rapidly, adaptability in the hospital setting is becoming more important. We look for ways to improve the care experience by delivering quality clinical measurements where and when they are needed, giving care providers the information they need to make the best possible clinical decisions. GE HealthCare’s CARESCAPE Canvas provides a precise, standardized, and flexible patient monitoring solution that adapts to patient needs with the ease of switching out a cable.”

Dr. Roland Schrewe, head of PICU, University of Frankfurt

“This new monitoring ecosystem has the potential for a hospital to have one single unified approach to patient monitoring that can be easily tailored for each patient. GE HealthCare is committed to offering flexible solutions that enable care teams to focus on the patient, not the technology. CARESCAPE Canvas’ innovative approach, where software and patient parameters can change in a very nimble manner, enables a standardized ecosystem that can adapt to changing healthcare needs.”

Neal Sandy, general manager, of monitoring solutions at GE HealthCare

As per DelveInsight’s “Patient Monitoring Devices Market” report, the global patient monitoring devices market was valued at USD 35.21 billion in 2021, growing at a CAGR of 8.20% during the forecast period from 2023 to 2028 to reach USD 56.46 billion by 2028. The patient monitoring devices market is observing market growth due to the factors such as the increasing prevalence of various chronic and lifestyle-associated disorders. Furthermore, the growing preferences for remote patient monitoring systems among the patient and healthcare providers, the increase in technological advancement in the product arena, and the rise in the approval of various patient monitoring devices, among others, are also some of the factors responsible for potentially increasing the global patient monitoring devices market during the forecast period. As per the Delveinsight analysis, in the type of devices segment, the cardiac monitoring devices sub-segment is expected to hold a considerable market share in the year 2021. This is primarily due to the rising prevalence of cardiovascular disorders (CVDs) worldwide, which could raise the demand for various cardiac monitoring devices.

Nevro Announced Enrollment of First Patient in PDN Sensory Study 

On April 24, 2023, Nevro Corp., a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, enrolled the first patient in its Painful Diabetic Neuropathy (PDN) Sensory study, which is the first prospective randomized controlled trial (RCT) to assess restoration of neurological function as a primary objective in patients with intractable PDN.

At various locations around the United States, the study will accept up to 236 people. Patients will be randomly assigned to receive either standard medical care alone or standard medical care combined with 10 kHz TherapyTM, with an option to switch to the other treatment arm after six months, if the required conditions are met.

The PDN Sensory Study and this possible device indication was given the Breakthrough Device Designation by the US FDA. This designation by the FDA allows for an accelerated review of a marketing application to broaden Nevro’s FDA labelling and give patients and healthcare professionals prompt access to vital medical devices that offer more effective diagnosis or treatment of life-threatening or permanently disabling illnesses or conditions.

“This PDN Sensory Study affords a path forward to building clinical evidence for slowing the progression of or improving the sensory loss of the lower limbs in patients with chronic intractable pain and builds on the significant outcomes seen in the landmark SENZA-PDN RCT. It also offers a unique opportunity for patients with refractory painful diabetic neuropathy to participate in a research study utilizing 10 kHz SCS, a proven minimally invasive, completely reversible technology, with powered study endpoints targeting the disease-modifying benefits of improved neurological function and pain relief.” 

Mitchell Engle, MD, Ph.D., Institute of Precision Pain Medicine in Corpus Christi, Texas

“The observed neurological improvements we saw in the SENZA-PDN study are unique to 10 kHz Therapy and have not been reported for any other competitive SCS modality. Not only do we anticipate that this study will provide additional confirmatory evidence of the benefits of Nevro’s proprietary 10 kHz Therapy in these PDN patients, but we also believe that the additional Level 1 data generated will be very helpful as we continue to work with payers to expand PDN coverage generally and professional societies to update PDN clinical treatment guidelines.”

Kevin Thornal, CEO and President of Nevro said

According to DelveInsight’s Diabetic Wounds Market” report, the global diabetic wounds market was valued at USD 2.22 Billion in 2021, growing at a CAGR of 7.48% during the forecast period from 2023 to 2028 to reach USD 3.44 Billion by 2028. The diabetic wounds market is witnessing positive growth owing to the rising prevalence of diabetes, the increase in diabetic foot ulcers among the population, the launch of novel active therapies, a surge in the number of amputations due to diabetic foot ulcers, and others are thereby contributing to the growth of the diabetic wounds market during the forecast period from 2023-2028.

Smith+Nephew Introduced First of its Kind Handheld Digital Tensioning Device for Robotically-Enabled Total Knee Arthroplasty

On April 24, 2023, Smith+Nephew, the global medical technology company, introduced its new CORI™ Digital Tensioner, a purpose-built device that lets surgeons measure the ligament tension in a knee before cutting bone.

The CORI Digital Tensioner reduces variability when balancing the knee in surgery by enabling a surgeon to measure joint laxity in the native knee and obtain an ideal ligament tensioning force. Compared to other commercially accessible methods, this makes surgery planning more objective.

To distract the knee joint, provide consistent stress to the ligaments, and give objective gap data for treatment planning and execution, the CORI Digital Tensioner generates a force that is defined and quantified by the surgeon. According to a short clinical case study, the CORI Digital Tensioner reduced tensioning variability by 64% when compared to a manual method.

Advancing procedural innovation in robotic-assisted surgery, the CORI Digital Tensioner is a differentiated technology that helps solve challenges for surgeons, including:

  • The first and only ligament tensioning device in robotic-assisted surgery to assess joint laxity in the native knee before performing bony resection. Automatic collection of gap data at a specified force through the full range of movement.
  • A true tensioning device using a software interface that allows surgeons to choose their preferred target force value (50±10N, 100±10N, or 150±10N).
  • The first commercial surgical procedure using the CORI Digital Tensioner was recently performed by Dr. Bertrand Kaper of Orthopedic Specialists of Scottsdale and HONORHEALTH Medical Group in Arizona.

“I’ve never seen anything like the digital tensioner before,” stated Dr. Steven Haas at Hospital for Special Surgery in New York. Dr. Steven Haas said, “You try to teach how much force to apply, but it varies by the surgeon and from one case to another. The CORI Digital Tensioner goes into the knee, you see a force or load being applied, and the gap it created. This technology is something I’ve wanted for the last twenty years.”

“The integration of this dedicated soft tissue tensioning device brings a new realm of objective data to the technique of knee replacement. The surgeon is now able to collect joint laxity data, in a proactive manner, to assist with the visualization, planning, and execution of the patient’s surgery in real-time. It’s unlike any other tool we’ve historically had available and will be a powerful addition to the robotic-assisted knee replacement technology that the CORI platform currently offers.”

Dr. Kaper

According to DelveInsight’s Knee Reconstruction/Replacement Devices Market” report, the global knee reconstruction/replacement devices market was valued at USD 7.87 billion in 2021, growing at a CAGR of 4.52% during the forecast period from 2023 to 2028 to reach USD 10.27 billion by 2028. The rise in demand for knee reconstruction/replacement devices is predominantly attributed to the burgeoning old-age population and the rising prevalence of various knee-associated musculoskeletal disorders such as osteoarthritis, rheumatoid arthritis, psoriatic arthritis, and others. Also, the growing demand for minimally invasive surgeries and technological advancement to improve the efficiency of the products are key market drivers. 

Medtronic Received FDA Approval for its MiniMed™ 780G System – World’s First Insulin Pump with Meal Detection Technology Featuring 5-Minute Auto Corrections

On April 21, 2023, Medtronic plc, the global leader in medical technology, got the US Food and Drug Administration (FDA) approval for its MiniMed™ 780G system with the Guardian™ 4 sensor requiring no fingersticks while in SmartGuard™ technology. 

It is the only device with meal detection technology that automatically adjusts and corrects blood sugar levels every five minutes for both basal (background) and bolus (mealtime) insulin demands. Further, when users occasionally forget to bolus or underestimate the amount of carbohydrates in their meal, the device automatically supplies insulin to assist make up for it.

In comparison to other automated insulin pumps, the MiniMed 780G system has the lowest glucose goal setting (as low as 100 mg/dL), which is closer to the average blood sugar of someone without diabetes. By selecting this option, the pump will treat to target and provide basal insulin adjustments and auto-corrections automatically to a predetermined target. 

It is also the only pump with an infusion set that can be worn for up to 7 days, doubling wear time with cutting-edge materials that assist preserve insulin flow and stability while reducing insulin preservative loss, leading to a decreased risk of infusion set blockage. 

The MiniMed 780G system has a user-friendly design due to the new Guardian 4 sensors. Users also noted that they stayed in the SmartGuard technology 95% of the time. During the clinical trials, users of the MiniMed 780G system experienced 75% Time in Range (blood sugar between 70 and 180 mg/dL) and 1.8% total Time Below Range. With an overnight Time in the Range of 82% and an overnight Time Below the Range of 1.5%, the system offered considerably more safety at night. Time in Range was attained at 78.8% without worsening hypoglycemia when the lower target of 100 mg/dL was used, and the active insulin time (AIT) was adjusted at two hours.

“Mealtimes prove to be one of the biggest challenges for people living with type 1 diabetes and now for the first time, the MiniMed 780G system addresses this unmet need with automatic, real-time insulin corrections. A lot can happen to blood sugars in an hour or even just a few minutes, so we’ve designed our system for real life – the algorithm adapts to the user and helps compensate for everyday challenges that are quite common around mealtimes. We built in features informed by extensive customer feedback and we’re excited to deliver a system with ease of use at the forefront.

Que Dallara, EVP and President of Medtronic Diabetes

According to DelveInsight’s “Blood Glucose Monitoring Systems Market” report, the global blood glucose monitoring systems market was valued at USD 13.06 billion in 2021, growing at a CAGR of 7.72% during the forecast period from 2023 to 2028, to reach USD 20.40 billion by 2028. The escalating demand for blood glucose monitoring systems is predominantly attributed to the increasing prevalence of diabetes among the population across the globe and the growing burden of the geriatric population who are susceptible to developing hyperglycemia. In addition, the spike in technologically advanced blood glucose monitoring devices product launches and government initiatives to raise awareness regarding proper diabetes management, among others, are likely to spur the global blood glucose monitoring systems market.

Syntr Health Technologies Announces Positive Data from Facial Fat Transfer Clinical Study

On April 25, 2023, Syntr Health Technologies, Inc., a medical device company dedicated to providing safe and effective solutions for patients and physicians, announced positive interim results from its post-market facial fat transfer clinical study.

Correction of the moderate-to-severe mid-face (Cheeks) and nasolabial folds (NLF) volume deficit were the multicenter study’s primary goals. The study also showed notable improvements in skin quality, volume retention, safety, and patient FACE-Q satisfaction scores as compared to pre-treatment (baseline) levels.

To address the volume loss in the nasolabial fold and cheeks brought on by aging, the study included more than 20 individuals. Using the FACE-Q’s measure of satisfaction with facial appearance Pre-treatment entry scores and overall scale findings showed that, on average, patients were either very or somewhat dissatisfied with various aspects of their facial appearance. 82% of patients reported being very satisfied or somewhat satisfied with their face look following treatment to the cheeks and nasolabial folds.

“We are thrilled by these results, as they are a testament to the SyntrFuge™ system’s ability to deliver predictable outcomes for patients. The data validates the effectiveness of SyntrFuge™ processed fat tissue as a long-term solution while maintaining optimal volume retention and achieving natural-looking results for patients.”

Dr. Hisham Seify, MD, Ph.D., FACS

“The ability to use your fat tissue as a natural solution to fillers is growing and patients are seeing firsthand the positive outcomes with our SyntrFuge™ processed fat. We are committed to delivering innovative solutions to ensure that fat is transferred with maximum viability and minimal loss to meet the needs of patients and physicians. This first-of-its-kind clinical study is just the beginning, and we look forward to continuing to advance the field of fat transfer.”

Ahmed Zobi, CEO of Syntr Health

According to DelveInsight’s “Facial Implants Market” report, the global facial implants market was valued at USD 2.56 billion in 2021, growing at a CAGR of 8.02% during the forecast period from 2023 to 2028, to reach USD 4.06 billion by 2028. The rise in the demand for facial implants is primarily attributed to the growing cases of face injuries across the globe. In addition, the increase in the volume of face reconstructive surgeries due to non-fatal injuries or facial deformities, growing demand for facial implant surgeries among the rising old age population to look aesthetically presentable, and increase in technological advancement in the product arena, among others are some of the key factors responsible for driving the global facial implants market during the forecasted period from 2023-2028.

Devyser Entered into an Agreement with Thermo Fisher Scientific for Commercialization of Devyser’s Post-Transplant NGS Products

On April 24, 2023, Devyser Diagnostics AB, pioneers in diagnostic kits and solutions for advanced DNA testing, announced that the company has signed an exclusive collaboration and distribution agreement with Thermo Fisher Scientific.

The agreement gives Thermo Fisher exclusive rights to commercialize, under combined brands, Devyser’s post-transplant portfolio of NGS products in North America and Europe. As a service to US laboratories, Devyser retains the ability to commercialize its post-transplant products in the US through its service laboratory. Devyser will continue to produce all goods covered by the contract.

Devyser ́s transplant portfolio includes Devyser Chimerism for screening and follow-up of post-stem cell transplantation and Devyser Accept cfDNA, a novel test for the detection of donor-derived cell-free DNA in blood samples from kidney-transplant patients. Additional products for post-transplant monitoring are currently under development at Devyser ́s R&D unit in Stockholm.

“Partnering with Thermo Fisher, the leading innovator in the HLA industry, is a great opportunity for Devyser and a significant milestone for our company. Through this strategic partnership, clinical labs, clinicians, and patients in the US, Canada, and Europe will have broad and fast access to Devyser ́s innovative NGS-based products for post-transplant monitoring. The agreement is also a quality stamp of our company and our products.

Fredrik Alpsten, CEO of Devyser

“We are excited to partner with Devyser. Their post-transplant NGS offerings are unique and highly complementary to our existing, One Lambda-branded products. I’m confident our partnership will support better patient outcomes.”

Nicole Brockway, President, of Transplant Diagnostics, Thermo Fisher Scientific,

“Thermo Fisher is very well-established and positioned in both the US and European market, and with their commercial infrastructure and resources, they can cover both US and Europe efficiently. Our sensitive assays and streamlined work process give labs the ability to provide fast and trusted results. Further, the Devyser post-transplant products are pending IVDR certification for the European market. Together, our brands provide a strong proposition to customers and laboratories across the transplantation field. Devyser will continue to grow and focus on product development in the transplant field.

Theis Kipling, CCO of Devyser

According to DelveInsight’s Next Generation Sequencing Market” report, the global next-generation sequencing (NGS) market was valued at USD 9.28 billion in 2021, growing at a CAGR of 18.96% during the forecast period from 2023 to 2028, to reach USD 26.30 billion by 2028. The increase in the demand for next-generation sequencing is attributed to the rising cases of infectious diseases, the sudden outbreak of COVID-19, and the escalating burden of cancer worldwide. Moreover, the rising application of NGS technology in clinical diagnosis and scientific research and advantages such as efficient turnaround results, high speed, and accuracy exhibited by the NGS technology, among others, are some of the factors that would contribute to the global next-generation sequencing market growth in the forthcoming years.