Orthofix Launched the Galaxy Fixation Gemini System and Expanded Sterile Kit Offerings for Orthopedic Trauma Procedures

On September 20, 2023, Orthofix Medical Inc., a leading global spine and orthopedics company, launched the Galaxy Fixation Gemini™ system. 

It is a stable external fixation system that is provided with several sterile procedure kit configurations; as a quick off-the-shelf solution for treating fractures that result from trauma in the lower and upper limbs.

The Galaxy Fixation Gemini ankle kit is a pin-to-bar system with specific clamps available in a sterile kit configuration giving surgeons more efficient solutions in lower extremity trauma situations where time is an important factor. 

“In trauma settings, we must respond quickly to manage the damage to the impacted limb,” said Dr. Evengy Dyskin, Clinical Assistant Professor of Orthopaedics, at the University of Buffalo, in Buffalo, NY. Dr. Evengy also added, “The all-inclusive nature of the sterile kits eliminates spatial constraints, enabling application in a trauma bay or intensive care unit setting, which would not be possible with a traditional pin-to-bar system.”

“We are excited to expand our external fixation offerings in the US for trauma through the introduction of the Galaxy Fixation Gemini System in several sterile packed configurations,” said Kim Elting, President of Global Orthopedics. Kim Elting also added, “This streamlined pin-to-bar configuration is the latest example of our leadership in sterile kit solutions, which improve OR efficiencies and meaningfully decrease costs for the hospital and also for our business.”

As per DelveInsight’s “Orthopedic Trauma Devices Market” report, the global orthopedic trauma devices market was valued at USD 7.01 billion in 2022, growing at a CAGR of 6.43% during the forecast period from 2023 to 2028 to reach USD 10.15 billion by 2028. The demand for orthopedic trauma devices is witnessing growth due to the rising number of accident and trauma cases, the growing prevalence of degenerative bone disorders, the rising number of sports-related injuries, the rising demand for technologically advanced products, and the increasing geriatric population are expected to drive product demand in the global orthopedic trauma devices market. 

Oxford Biodynamics Launched the EpiSwitch® Prostate Screening Blood Test to Men with Prostate Cancer Risk in the US 

On September 26, 2023, Oxford BioDynamics, Plc, a biotechnology company developing precision medicine tests based on the EpiSwitch® 3D genomics platform, announced the validation of its EpiSwitch Prostate Screening (PSE) blood test in its US clinical laboratory, resulting in the immediate access to its highly accurate PSE test to men with prostate cancer risk. It is now instantly available to men being screened for prostate cancer in the US.

The PSE test is used in conjunction with a regular PSA test to accurately predict the presence or absence of prostate cancer 94% of the time.

The PSE test has a high specificity of 97% (PSA: 53%) and sensitivity of 86% (PSA: 64%), along with both high positive, 93% (PSA: 25%), and high negative, 95% (PSA: 86%), predictive values to assess the risk of prostate cancer in men

The test is completed via a simple ordering system by a patient’s doctor, with results available in five days after a blood sample is received.

“Although the traditional PSA has demonstrated clinical utility in prostate cancer screening and monitoring, it also has limitations that are well-described,” said Dr. Phillip Pierorazio, Section Chief of Urology at Penn Presbyterian Medical Center, and Professor of Surgery at the Hospital of the University of Pennsylvania. Dr. Phillip said, “A more sensitive and specific test would have the potential to increase diagnostic accuracy and address some of the current challenges with prostate cancer screening.”

“There is a clear need in everyday clinical practice for a much more accurate blood test that can screen men for prostate cancer and accurately identify those at risk while sparing those who up to now would be subject to unnecessary, expensive, and invasive procedures. It feels wholly appropriate that the early launch of the test coincides with Prostate Cancer Awareness month,” said Dr Jon Burrows, OBD’s Chief Executive Officer. Dr. Jon Burrows added, “With the news today of the launch of another EpiSwitch-based product, we are continuing to improve patient health whilst also reducing the cost of care.”

According to DelveInsight’s “Cancer Diagnostics Market” report, the global cancer diagnostics market was valued at USD 125.13 billion in 2022, growing at a CAGR of 9.43% during the forecast period from 2023 to 2028, to reach USD 214.88 billion by 2028. The increase in demand for cancer diagnostics products and services is predominantly attributed to the spike in cancer cases reported worldwide. In addition, growing manufacturers’ focus on developing advanced cancer diagnostic products, the establishment of various cancer diagnostic labs, and rising government initiatives to raise awareness regarding early detection and management of cancer among patients, and others are anticipated to drive the global cancer diagnostics market during the forthcoming years. 

Medtronic Diabetes Announced the CE Mark for the new Simplera™ CGM with disposable all-in-one design

On September 21, 2023, Medtronic plc, a global leader in healthcare technology, received CE Mark approval for its new all-in-one, disposable Simplera™ continuous glucose monitor (CGM) featuring a simple, two-step insertion process. 

The new no-fingerstick sensor does not require overtape and is seamlessly integrated with the InPen™ smart insulin pen, which provides real-time, personalized dosing guidance to help simplify diabetes management.

Simplera™ is indicated for aged 2+ and compatible with iOS and Android.

“Patients with diabetes can get overwhelmed by the sheer number of decisions they need to make daily. As a physician, I appreciate the ability to introduce this solution by Medtronic as it provides real-time, personalized guidance to help patients stay in range. For instance, when it detects someone is consuming a meal and their glucose levels are trending high, it alerts the person to help make diabetes management easier and provides peace of mind,” said Dr. Sandra Schlüter, Endocrinologist, Germany, and Head of AGDF. 

“Despite the rapid adoption of CGM over the past decade, less than 30% of individuals on MDI therapy using a CGM achieve glycemic targets — highlighting a significant unmet need.1-4 We’re excited to help more people reach their goals with our advanced algorithm in InPen™ powered by our smallest and most comfortable CGM to date,” said Que Dallara, EVP and President, Medtronic Diabetes. Que Dallara added, “This newest addition of a Smart MDI solution to our holistic portfolio demonstrates our commitment to meeting people where they are in their diabetes journey with simplified solutions that help make life with diabetes easier.” 

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 2022, 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 hyperglycaemia. In addition, the spike in technologically advanced blood glucose monitoring devices product launch and government initiatives to raise awareness regarding proper diabetes management, among others are the factors likely to spur the global blood glucose monitoring systems market.

MicroVention, Inc. Received FDA 510(k) Clearance for its SOFIA™ EX 5F 115cm Intracranial Support Catheter 

On September 21, 2023, MicroVention, Inc., a global neurovascular company and wholly owned subsidiary of Terumo Corporation, received FDA 510(k) clearance for the SOFIA™ EX 5F 115 cm Intracranial Support Catheter (Soft Torqueable catheter For Intracranial Access). 

A large internal lumen makes the SOFIA™ EX 5F Catheter extremely trackable, and this enables quick and efficient tracking of intracranial regions in patients. SOFIA™ EX provides support and kink resistance and is reinforced with a nitinol coil and stainless-steel braid. The catheter has a PTFE inner liner the entire length with 12 pushability-optimized transition zones.

In contrast to transfemoral access, which uses the femoral artery in the groyne, trans-radial access makes use of the radial artery in the wrist. 

The SOFIA™ EX 5F radial access clearance is the first radial access solution from MicroVention and demonstrates our dedication to innovation. Providers should be able to feel confident using our SOFIA™ EX 5F in either the trans-radial or transfemoral access strategy, according to MicroVention.

“We are pleased to receive FDA clearance for MicroVention’s SOFIA™ EX 5F Intracranial Support Catheter for transradial access,” said Carsten Schroeder, CEO, of MicroVention. Carsten also added, “This achievement signifies our commitment to radial neurointervention and represents our unwavering commitment to improving healthcare and helping to save patient lives while striving to be at the forefront of innovation.”

According to DelveInsight’s “Diagnostic Catheters Market” report, the global diagnostic catheter market was valued at USD 4,497.47 million in 2022, growing at a CAGR of 6.65% during the forecast period from 2023 to 2028 to reach USD 6,601.68 million by 2028. The diagnostic catheter market is observing remarkable market growth due to factors such as the growing prevalence of various chronic disorders such as cardiovascular, neurological, and urological, among others. Furthermore, the rising demand for imaging devices in disease diagnosis, growing technological developments in the imaging catheter, an increasing number of imaging and diagnostic centers, an increasing product launch and approvals, and the presence of key players in the market, among other factors will create a requisite for the diagnostic catheters market. Therefore, the market for diagnostic catheters is estimated to grow at a substantial CAGR during the forecast period from 2023 to 2028.

SHL Telemedicine’s SmartHeart® Technology Presented Positive Results in Mayo Clinic and Imperial College London Trials 

On September 26, 2023, SHL Telemedicine Ltd., a leading provider and developer of advanced personal telemedicine solutions, announced the initial results from the Mayo Clinic HELP-MI and the Imperial College London TELE-ACS trials.

SmartHeart®️ is an electrocardiogram (ECG or EKG) technology through which users can perform a full mobile (EKG) in any setting, including the patient’s home, using any mobile device, including smartphones and tablets.

Key highlights from the presentation of the initial results include:

  • A staggering decrease of -27.5% in emergency room visits in the TELE-ACS trial was observed
  • Hospital readmission rates plummeted by -55% in the TELE-ACS trial
  • In the HELP-ME trial, cardiovascular-driven emergency department visits for patients using the SmartHeart® device were reduced to an astonishing 0 (zero)
  • Cardiovascular-driven re-hospitalization was also at 0 (zero) for patients using the device in the HELP-ME trial
  • The SHL’s system be successfully replicated in the US medical system, emphasizing its capability to reduce non-indicated cardiovascular emergency department visits and hospitalizations while improving early recognition of serious cardiovascular presentations.

Erez Nachtomy, CEO of SHL Telemedicine, commented, “The initial results from the HELP-MI and TELE-ACS trials have surpassed our expectations. We are extremely confident in the potential of our SmartHeart® technology, and these findings further validate its efficacy in post-MI patient care. We are looking forward to the continued positive impact our technology will have on telemedicine and remote patient care.”

According to DelveInsight’s “Cardiac Monitoring Devices Market” report, the global cardiac monitoring devices market will grow at a CAGR of 5.4% during the forecast period from 2023 to 2028. The demand for cardiac monitoring devices is primarily being boosted by the rising prevalence of cardiovascular diseases, technological advancements in product development, increasing geriatric population, sedentary lifestyle, and increasing awareness programs regarding cardiovascular health.

Cardiosense Started Enrollment in Nationwide Heart Failure Study

On September 26, 2023, Cardiosense, a digital health company developing a non-invasive monitoring platform for the early detection of heart disease, started enrolling patients in SEISMIC-HF I, its nationwide clinical study to refine and validate algorithms to assess intracardiac filling pressure, an early physiological marker for acute heart failure decompensation. 

The algorithms leverage data captured by CardioTag, Cardiosense’s non-invasive patch that measures key parameters of cardiac function.

Cardiosense was awarded FDA Breakthrough Device Designation in 2022.

“Elevated intracardiac filling pressures are a clinically proven indicator for decompensated heart failure and hospitalization, but so far has largely been possible only through invasive methods, limiting its utility to a broader population,” said Anjan Tibrewala, M.D. of Northwestern Medicine’s Bluhm Cardiovascular Institute. Anjan Tibrewala added, “Cardiosense’s technology has the potential to be a game-changing solution in remotely monitoring patients with heart failure. I’m excited to participate in the SEISMIC-HF I study and that Northwestern Medicine was the first site to enroll patients.”

According to DelveInsight’s “Congestive Heart Failure (CHF) Treatment Devices Market” report, the global congestive heart failure (CHF) treatment devices market was valued at USD 17.41 billion in 2022, growing at a CAGR of 8.26% during the forecast period from 2023 to 2028 to reach USD 27.96 billion by 2028. The congestive heart failure (CHF) treatment devices market is witnessing positive growth owing to the rising incidence of cardiovascular diseases (CVDs), a surge in research and development activities in product development, and increasing incidences of the aging population who are susceptible to these diseases. Moreover, sedentary lifestyle and the extreme benefits of these devices in heart failure cases during the pandemic and the growing popularity of minimally invasive interventions have further pushed the demand for these devices, thereby contributing to the growth of congestive heart failure (CHF) treatment devices market during the forecast period from 2023-2028.