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Tandem Diabetes Care Completed Acquisition of the Insulin Patch Pump Developer, AMF Medical
On January 23, 2023, Tandem Diabetes Care, Inc., a global insulin delivery and diabetes technology company, announced the complete acquisition of AMF Medical SA, the privately held Swiss developer of the SigiTM Patch Pump.
The Sigi Patch Pump is a rechargeable, ergonomic patch pump that uses pre-filled insulin cartridges to ease the burden of managing diabetes. It is still in development and is not yet on the market.
“AMF Medical’s compelling technology aligns well with our strategic vision to include a patch pump in Tandem’s portfolio of differentiated offerings,” said John Sheridan, Tandem Diabetes Care President and Chief Executive Officer. He further added, “In addition to this innovative technology, the talented AMF team joining our Tandem family shares our commitment to simplify diabetes management and brings decades of experience from the diabetes device, life sciences, and watch-making industries.”
Peter Ryser, AMF Medical’s Chairman and Co-Founder, said, “AMF Medical was founded to develop a patch pump that is not only simple to use for people with diabetes, but also optimized for scale manufacturing.”
“We are thrilled that our work will be carried forward by a mission-driven company like Tandem. Tandem not only shares our deep-rooted dedication to diabetes technology, but has created an incredibly user-focused culture that is very well aligned with our company values,” added Antoine Barraud, Co-Founder and Co-CEO of AMF Medical.
As per DelveInsight’s “Insulin Delivery Devices Market” report, the global insulin delivery devices market was valued at USD 15.51 billion in 2021, growing at a CAGR of 9.28% during the forecast period from 2022 to 2027 to reach USD 26.35 billion by 2027. The demand for insulin delivery devices market is expected to grow owing to the rising prevalence of diabetes among the geriatric population, favorable reimbursement scenarios, rising awareness about proper diabetes management and insulin delivery devices, and technological advancement in the product line, among others, ultimately contributing to the overall growth of the insulin delivery devices market during the forecast period from 2022-2027.
NeuroMetrix® Launched DPNCheck® 2.0 Device for Peripheral Neuropathy
On January 23, 2023, Neurometrix, Inc., announced the launch of DPNCheck 2.0, the business’s most recent point-of-care device that uses industry-leading nerve conduction technology to identify peripheral neuropathy.
Rapid patient screening with quantitative measurement of peripheral nerve function is offered by DPNCheck 2.0. A user-friendly touchscreen, step-by-step instructions built in, improved temperature compensation, a real-time nerve response display, and other improvements are included. The software that comes with it makes it easier to document test results clinically. Population health data will be collected in the cloud this year and integrated with provider EHR systems.
It is possible to identify elevated risk for these complications earlier and more precisely by incorporating peripheral neuropathy screening using nerve conduction technology, as opposed to conventional clinical approaches like the monofilament and tuning fork tests.
Shai N. Gozani, M.D., Ph.D., Chief Executive Officer, NeuroMetrix said, “For more than a decade, our first-generation DPNCheck device has been used and trusted by thousands of providers to assess over 2-million patients. We are excited to launch our newest version to even better address the needs of our clinical partners. We’ve opened the door to more widespread screening with a user-friendly design that makes it faster and easier for care organizations to roll out and train their point-of-care staff and deploy testing.”
According to DelveInsight’s “Peripheral Nerve Repair Devices Market” report, global peripheral nerve repair devices is anticipated to grow at a CAGR of 10.76% during the forecast period from 2022 to 2027. The demand for peripheral nerve repair devices is primarily being boosted by increasing incidence of peripheral nerve injuries due to increase in trauma cases and prevalence of lifestyle disorders such as hypertension and diabetes. Further, the increasing prevalence of cancers, innovation in product development, among others are thereby contributing in the growth of the peripheral nerve repair devices market during the forecast period from 2022-2027.
Cytovale Received FDA Approval for its IntelliSep® Sepsis Test, the First in a New Class of Emergency Department-Focused Diagnostic Tools
On January 18, 2023, Cytovale®, Inc., a medical diagnostics company focused on advancing early detection technologies to diagnose fast-moving and immune-mediated diseases, announced that the FDA has granted clearance for its IntelliSep® test, which will help the approximately 30 million adult patients with signs and symptoms of infection who visit US emergency departments (ED) each year.
With test results available in under 10 minutes, IntelliSep is a revolutionary diagnostic tool that supports crucial time-sensitive clinical decisions and assists clinicians in recognising sepsis. The test is a straightforward, quick, and intuitive solution that delivers useful results right from a routine blood draw. It is the first in a new class of ED-focused diagnostic tools that assess host response.
According to their likelihood of developing sepsis, IntelliSep divides patients into three bands, with Band 1 denoting a low likelihood and Band 3 denoting a high likelihood. A hospital’s efforts to adhere to the Centers for Medicare & Medicaid Services’ (CMS) SEP-1 guidelines for timely sepsis treatment may be assisted by IntelliSep.
Utilizing immune cell morphology, IntelliSep’s ground-breaking technology measures the body’s immune response to an infection. IntelliSep can offer important new insight into sepsis by applying pressure to tens of thousands of cells and observing how they respond. White blood cells from septic patients’ biophysical characteristics change noticeably when put under pressure; these changes are photographed and then characterized by a proprietary algorithm to produce a result.
“Early detection of sepsis is an invaluable capability for healthcare professionals. Quickly identifying sepsis is critical to saving lives, but until now, we’ve lacked a reliable tool to either recognise the condition or explore alternate diagnoses,” said Hollis O’Neal, MD, Medical Director of Research at Our Lady of the Lake Regional Medical Center, Critical Care Physician at LSU Health Sciences Center, and National Principal Investigator on the multi-center CV-SQuISH-ED study that supported the clearance. “IntelliSep is truly a game changer for sepsis because it provides a unique indicator that gets to the heart of the current sepsis definition, immune dysregulation. The test provides hospital staff with the information needed to identify and treat septic patients efficiently and reduce the financial and health burdens of overtreatment for hospitals and patients.”
According to DelveInsight’s “Sepsis Diagnostics Market” report, the global sepsis diagnostics market was valued at USD 644.48 million in 2021, growing at a CAGR of 9.60% during the forecast period from 2022 to 2027 to reach USD 1114.82 million by 2027. The sepsis diagnostics market is witnessing positive growth owing to various factors such as the increasing prevalence of the COVID-19 pandemic, a rise in the geriatric population, the increasing prevalence of bacterial infections such as tuberculosis, and the surge in the regulatory approvals for the technologically advanced sepsis diagnostics products. Therefore, the market for sepsis diagnostics is estimated to grow at a significant CAGR during the forecast period from 2022 to 2027.
icotec ag Received FDA Clearance for the Ø 4.5mm VADER® Pedicle Screws
On January 24, 2023, icotec ag, the leading medical device manufacturer of Carbon/PEEK spinal implants confirmed that the VADER® Pedicle System, which includes extended long Carbon/PEEK rods made from BlackArmor® and 4.5 mm pedicle screws, received FDA 510(k) clearance to be marketed.
The VADER® Pedicle System now consists of rods in various shapes up to 300 mm in length and pedicle screws with diameters between 4.5 and 7.5 mm in lengths of 25 to 60 mm. BlackArmor® Carbon/PEEK composite material is used exclusively in the manufacture of VADER® screws and rods. BlackArmor® provides complete radiolucency and excellent spine stabilisation, improving radiation planning and dose delivery, enhancing visualisation in postoperative imaging, and extending treatment options for patients with spinal tumours.
The extended VADER® Pedicle System offered more options for stabilising the upper thoracic region of the spine while maintaining its well-established indication and adaptability for open, MIS, and cement-augmented surgical techniques.
icotec ag CEO, Roger Stadler said, “Thoracic spine hosts 60% of metastatic tumors. We are incredibly proud that icotec, with the expansion of its VADER® product family to include cannulated and fenestrated 4.5 mm pedicle screws and longer rod options, is the market leader in extended solutions for the stabilisation of this frequently affected spinal region. A significant accomplishment that shows our dedication to continuing to create and market spinal implants made of radiolucent BlackArmor®, which will increase treatment options and enable safer tumor care.”
According to DelveInsight’s “Spinal Implants Market” report, the global spinal implants market was valued at USD 13.01 billion in 2021, growing at a CAGR of 5.40% during the forecast period from 2022 to 2027 to reach USD 17.84 billion by 2027. The rise in demand for spinal implants is predominantly attributed due to the increasing prevalence of various spinal disorders which include spinal stenosis, disc herniation, and degenerative disc diseases, among others in the older population across the globe. Moreover, shifting focus towards technological advancement in bone graft products, rising awareness among the patient population regarding spinal disorder and their proper management, and rising preferences for minimally invasive surgeries are the factors driving the spinal implants market.
Pie Medical Imaging Announced the Inclusion of 500 Patients in the vFFR FASTIII Trial
On January 20, 2023, Pie Medical Imaging, a global leader in cardiac imaging, announced the inclusion of the 500th patient in the multicenter randomized clinical trial FAST III, which examines the use of vessel fractional flow reserve (CAAS vFFR) based on angiography in patients undergoing coronary revascularization procedures.
To direct coronary revascularization, this trial compares a CAAS vFFR guided strategy to an FFR guided strategy. At one year after randomization, the primary endpoint is a composite of all-cause mortality, any myocardial infarction, or any revascularization.
The angio-based FFR software suite CAAS vFFR enables physiological assessment of intermediate coronary stenosis without the use of a pressure wire and adenosine. With just two angiographic projections and the aortic root pressure, the vFFR value can be calculated. In comparison to wire-based invasive FFR and NHPR measurements, this vFFR has a high correlation and diagnostic accuracy, and the results have been shown to be highly reproducible.
The trial is a non-inferiority, international, multicenter, investigator-initiated trial. At 25 locations in the Netherlands, Germany, Spain, Ireland, United Kingdom, Italy, and France, hospitals with extensive experience in coronary physiology enrol 500 patients. With a goal of 2,228 patients by the end of the year, 35 sites will be added in total.
“The FAST III trial, together with several other studies currently being performed with CAAS vFFR, will increase the scientific body of evidence showing that the CAAS vFFR software is an excellent alternative to invasive wire-based physiological measurements,” said Rene Guillaume, Managing Director PMI.
According to DelveInsight’s “Coronary Angiography Devices Market” report, the global coronary angiography devices market was valued at USD 11.72 billion in 2021, growing at a CAGR of 6.18% during the forecast period from 2022 to 2027, to reach USD 16.80 billion by 2027. The demand for coronary angiography devices is primarily witnessing growth on account of the growing prevalence of cardiovascular diseases, rising numbers of coronary angiography procedures, technological advancements in coronary angiography devices and increasing product approvals for advanced angiography techniques.
Hip Innovation Technology Announced Initiation of FDA-Approved Investigational Device Exemption Study
On January 12, 2023, Hip Innovation Technology, a medical device company developing innovative orthopedic device solutions to advance the quality of life and quality of care for patients announces the first HIT Reverse Hip Replacement System (Reverse HRS) implant in the United States, carried out under an FDA-approved Investigational Device Exemption (IDE).
To ascertain the safety and efficacy of the HIT Reverse HRS in Primary Total Hip Arthroplasty, the IDE Study is being carried out (THA). The gathering of metrics for patient quality of life and device-related adverse events will be used to evaluate safety. Utilizing clinical, radiologic, and patient-reported outcomes, effectiveness will be assessed.
Stephen Zabinski, MD, Director of the Division of Orthopaedic Surgery, Shore Medical Center in Somers Point, New Jersey, said, “The reverse hip replacement system offers potential unique benefits regarding motion and stability. My first patient was very educated and after researching the implant, was motivated to proceed. Her surgery went extremely well, and I’m excited to see her in follow up, and to use the Reverse HRS in additional patients.”
“The Reverse HRS is a novel hip implant design that we believe represents breakthrough technology and a significant advancement for patients requiring total hip arthroplasty,” said George Diamantoni, Co-Founder and Chief Executive Officer of Hip Innovation Technology. “We look forward to rapidly enrolling patients in this important clinical study and validating potential clinical benefits including, hip stability at extended ranges of motion, reduced risk of device dislocation and greater latitude for placement of hip components relative to the currently marketed designs.”
According to DelveInsight’s “Hip Reconstruction/Replacement Devices Market” report, the global hip reconstruction/replacement devices market was valued at USD 9.26 billion in 2021, growing at a CAGR of 5.06% during the forecast period from 2022 to 2027 to reach USD 12.44 billion by 2027. The rise in demand for hip reconstruction/replacement devices is primarily due to the rising geriatric population across the globe, increase in obesity owing to sedentary lifestyle, introduction of custom-made implants, and technological advancement in the product portfolio, among others.