Medtronic Announced First Patient Enrolment for Hugo™ Robotic-Assisted Surgery System in US Clinical Trial

On December 15, 2022, Medtronic, a global healthcare technology leader, announced that the first patient was enrolled in the Expand URO US clinical trial for the Hugo™ robotic-assisted surgery (RAS) system.

A smart, digitally enabled surgical experience is provided by the Touch Surgery™ Enterprise system in conjunction with the Hugo™ RAS system. It is used in hospitals on three different continents outside of the United States for a variety of urology, gynecology, and general surgery procedures.

Smaller scars, fewer complications, shorter hospital stays, and quicker return to normal activities are all benefits of minimally invasive surgery, including robotic-assisted surgery. One of the most frequent operations assisted by a surgical robot is urologic surgery. 

In this study, urologic surgical procedures such as radical prostatectomy, radical cystectomy, and nephrectomy (partial or radical) procedures are intended to be performed at sites in the United States using the Hugo™ RAS system. 

In some regions, the Hugo™ RAS system is commercially available. Hugo™ RAS system market availability and approved indications will be determined by regulatory requirements and status in various nations and regions. 

Carla Peron, M.D., chief medical officer of the Surgical Robotics business said, “Scientific evidence is the bedrock of healthcare technology innovation and adoption. It creates and builds trust among clinicians and patients. We’re proud to further that important pursuit with the Hugo RAS system in partnership with hospitals and surgical teams in the United States who share our commitment to patients.”

“This is an exciting time for healthcare in the United States and around the world, as we have the opportunity to expand robotic-assisted surgery treatment options to more patients,” said Dr. Porter, who plans to perform his first cases under the trial. He further added, “Backed by a growing body of clinical evidence, robotic-assisted surgery is the preferred approach within urology given the anatomical access, precision, and ergonomic advantages it enables.”

As per DelveInsight’s “Surgical Robotic Systems Market”  report, the global surgical robotic systems market was valued at USD 5.02 billion in 2021, growing at a CAGR of 11.50% during the forecast period from 2022 to 2027 to reach USD 9.64 billion by 2027. The demand for surgical robotic systems market is expected to grow owing to the spike in surgical procedures which can be attributed to various factors such as the increasing geriatric population who form a big part of the at-risk population for prostate cancer, valvular diseases, endometriosis, among other diseases. Further, the growing need for robot-assisted surgery systems due to the growing inclination towards minimally invasive surgical approaches, and the innovation in product development is paving the way for miniaturized surgical robots ultimately contributing to the overall growth of the surgical robotic systems market during the forecast period from 2022-2027. 

Life Spine Received FDA 510(K) Clearance for Trulift® Lateral Expandable Spacer System and Lateral Pate System 

On December 14, 2022, Life Spine, a medical device company, announced the U.S. Food & Drug Administration (FDA) approval to market the TruLift Lateral Expandable Spacer System and Lateral Plate System. The company develops, produces, and markets products for the surgical treatment of spinal disorders.

The TruLift Lateral can be expanded to the desired height (8mm to 16mm) to accommodate the unique pathology and anatomical conditions of the patient. It is available in a variety of sizes and footprints. The TruLift Lateral Expandable Spacer may optionally be attached to the 1-, 2-, and 4-screw Lateral Plates, which immediately stabilize and fixate the lumbar spine.

Benefits and Features of TruLift Lateral:

  • Up to 8mm of in-situ expansion and disc height restoration
  • Minimal impaction; preservation of end plate integrity
  • A design that lessens psoas irritation

Features and advantages of lateral plates: 

  • Plate teeth provide intraoperative stabilization and prevent postoperative plate rotation
  • Optional connection screw to fasten the plate to the interbody
  • Minimizes risk of implant migration

“TruLift Lateral and Lateral Plate System offer next-generation technology for Lateral Lumbar Interbody Fusions. The system features robust titanium, expandable interbody that allows for plate fixation devices to attach easily and accurately. These plates are offered in multiple configurations and sizes. Separately or combined, these innovative systems further our commitment to Micro Invasive Procedures.” said Rich Mueller, Chief Operating Officer of Life Spine. 

According to DelveInsight’s “Spinal Surgery Devices Market” report, global spinal surgery devices is anticipated to grow at a CAGR of 5.65% during the forecast period from 2022 to 2027. The spinal surgery devices market is estimated to register positive revenue growth owing to various factors such as the subsequent rise in spinal disorders across the globe, increasing road accidents, and the increasing demand for minimally invasive surgical procedures among others. Further, the increasing demand for technologically advanced spinal surgery devices along with the increasing product launches and approvals will spur the market for spinal surgery devices during the forecast period from 2022-2027. 

Abbott Launched the World’s Smallest Implantable, Rechargeable Spinal Cord Stimulation System for Chronic Pain

On December 19, 2022, Abbott, launched the EternaTM spinal cord stimulation (SCS) system, the smallest implantable, rechargeable spinal cord stimulator currently on the market for the treatment of chronic pain, and has been approved by the U.S. Food and Drug Administration (FDA). 

Abbott’s low-dose BurstDR™ stimulation, the only SCS waveform technology with the highest level of clinical evidence, is used in Eterna SCS and has been shown to reduce pain 23% more than conventional waveform technology methods.

To comprehend the unmet needs of people with chronic pain, Abbott conducted extensive studies with patients, doctors, and carers before developing Eterna. According to the studies, people preferred a smaller implant because it would be more comfortable and require less frequent charging. Abbott designed Eterna to require recharging no more than five times annually with normal use, making it the platform with the lowest recharge burden available. 

Some of the product’s key features include:

  • Clinically validated treatment: Abbott’s patented BurstDR stimulation, which imitates the brain’s natural firing patterns to provide superior pain relief, is a feature of the Eterna SCS system. 87% of patients prefer burstDR stimulation to conventional tingling tonic stimulation.
  • Most minimal recharging needs: Eterna improves the patient charging experience when combined with Abbott’s new Xtend™ energy technology, requiring as few as five recharges annually under typical use from a wireless charger.
  • MRI capabilities: Eterna makes use of Abbott’s TotalScan™ MRI technology, which enables full-body MRI scans, which are essential for chronic pain patients who need access to better diagnostics and medical care.
  • Platform upgradeable: The Eterna SCS system can adapt to upcoming innovations without replacing the implant as Abbott makes improvements to SCS therapy.
  • iPhone integration: Using an Apple device that is either owned by the user or provided by Abbott, the patient-focused mobile app from Abbott supports real-time battery and charging status updates for the Eterna SCS system.

“Abbott’s low-dose BurstDR stimulation is clinically proven to reduce pain, improve people’s ability to perform everyday activities, and reduce emotional suffering associated with pain. Until now, it wasn’t available on a rechargeable device that was this small, and that only needs to be charged a few times a year. This makes a big difference in comfort for many patients who now can have access to the best of both worlds – a small, best-in-class rechargeable device with superior stimulation therapy.” said Timothy Deer, M.D., DABPM, president and chief executive officer of the Spine and Nerve Centers of the Virginias in Charleston, W.Va.

According to DelveInsight’s “Spinal Cord Stimulators (SCS) Market” report, the global spinal cord stimulators market was valued at USD 2.25 billion in 2021, growing at a CAGR of 8.70% during the forecast period from 2022 to 2027, to reach USD 3.72 billion by 2027. The demand for spinal-cord stimulators is primarily attributed to the growing number of patients with chronic pain, and neuropathic pain in the shoulder, legs, and knee. The technologically advanced devices that are non-invasive, eliminate targeted pains, and cause a reduction in pain discomfort, with no side effects are likely responsible for a boost in the global spinal cord stimulators market growth. Moreover, the favorable government regulations for commercialization and launching new and advanced products in the market are some of the factors responsible for propelling the growth of the spinal cord stimulators market during the forecast period from 2022-2027.

Insightec Enrolled First Patients in the Pivotal LIBERATE Clinical Trial

On December 15, 2022, Insightec, a global healthcare company dedicated to using acoustic energy to transform patient care, announced the first patient’s enrolment in the pivotal LIBERATE clinical trial (Liquid Biopsy with Low-Intensity Ultrasound in Brain Tumors). 

The enrollment in LIBERATE heralds the beginning of an international effort to evaluate the efficacy and safety of temporarily rupturing the blood-brain barrier (BBB) in patients with glioblastoma, the most prevalent primary malignant brain tumor in adults, using Insightec’s focused ultrasound (FUS) platform.

The Mayo Clinic (Drs. Terry Burns, MD, PhD, and Timothy Kaufmann, MD, MS), as well as Sunnybrook Health Sciences Centre, in the US and Canada, respectively, enrolled the first patients (Dr. Nir Lipsman MD PhD).

During the trial blood samples are taken both before and after the BBB is disrupted to check for increases in circulating free DNA that is enabled by FUS (cfDNA). The study evaluates the relationship between the mutation profiles in the tumor tissue obtained during standard-of-care invasive surgical resection and/or biopsy and the mutation profiles in the released cfDNA, or circulating tumor DNA (ctDNA).

“Liquid biopsy is a new approach for non-invasive cancer diagnosis and monitoring in brain tumors. Despite remarkable progress in other cancers, liquid biopsy has had limited success in brain tumors due to the presence of the blood-brain barrier (BBB). This pivotal trial is designed to assess for the first time the clinical benefit of using low-intensity focused ultrasound (LIFU) to transiently increase the permeability of the BBB and allow passage of region-specific biomarkers to enable incisionless liquid biopsy in brain tumors.” said Dr. Achal Singh Achrol MD, Chief Medical Officer of Insightec.

Dr. Maurice R. Ferré MD, CEO and the Chairman of the Board of Directors at Insightec said, “Insightec is committed to supporting these leading physician-scientists at these world-renowned institutions as they seek to advance the field of incisionless neurosurgery. All of us at Insightec are proud to be supporting the LIBERATE investigators and the launch of this pivotal trial is an important step forward in the fight against glioblastoma. Our ultimate goal is, as always, to positively impact patient lives.”

According to DelveInsight’s “Liquid Biopsy in Cancer Diagnostics Market” report, the liquid biopsy in cancer diagnostics market was valued at USD 7.64 billion in 2021, growing at a CAGR of 16.64% during the forecast period from 2022 to 2027, to reach USD 19.24 billion by 2027. Factors such as the rising incidence of various cancers, the growing demand for minimally invasive procedures, the increasing demand for precision medicine, and technical innovation in product developments among others are anticipated to drive the global liquid biopsy in the cancer diagnostics market during the forthcoming years.

FDA Granted Emergency Use Authorization for Thermo Fisher Scientific’s Monkeypox Test

On December 14, 2022, Thermo Fisher Scientific, the leader in advancing science received the U.S. Food and Drug Administration (FDA) approval of an emergency use authorization (EUA) for the polymerase chain reaction (PCR) test called the Applied Biosystems TaqPath Monkeypox/Orthopox Virus DNA Kit, which can identify non-variola orthopoxviruses, including monkeypox virus, in about three and a half hours. 

The test is designed to qualitatively detect DNA from the monkeypox virus (clade I/II) and screen for non-variola orthopoxviruses in human lesion swab samples from patients whose healthcare providers suspect they have monkeypox (mpox) infection. The TaqPath Monkeypox/Orthopox Virus DNA Kit is also made for the detection of DNA from other orthopoxviruses other than variola.

Although positive results are a sign that DNA from the monkeypox virus or another non-variola orthopoxvirus is present, clinicians must still compare the results of the PCR with the patient’s medical history and other diagnostic data to determine the patient’s infection status. 

The TaqPath Monkeypox/Orthopox Virus DNA Kit expands on that technology and demonstrates Thermo Fisher’s ongoing dedication to creating diagnostic tools that can be used as soon as possible to address urgent public health emergencies.

“Ensuring that all U.S. laboratories have access to monkeypox PCR testing is a critical part of the response to this public health emergency. “This helps expedite availability of results so that patients can receive the appropriate treatment quickly. Authorized testing also enables public health agencies to stay one step ahead of the virus by monitoring viral spread and addressing affected populations accordingly.” said Manoj Gandhi, senior medical director for Genetic Testing Solutions, Thermo Fisher Scientific. 

According to DelveInsight’s “In Vitro Diagnostics Market” report, the global in-vitro diagnostics market was valued at USD 71.01 billion in 2021, growing at a CAGR of 4.71% during the forecast period from 2022 to 2027 to reach USD 93.60 billion by 2027. The in vitro diagnostics market is estimated to register positive revenue growth owing to the factors such as the rising prevalence of various infectious diseases such as COVID-19, the growing prevalence of various cancers, the increasing cases of hematological diseases, and the increasing product development activities concerning in vitro diagnostics among others. 

Fujifilm Announced Asset Purchase Agreement with Inspirata, Inc. to acquire the company’s Digital Pathology Business

On December 19, 2022, FUJIFILM Corporation, signed a contract to buy Inspirata, Inc.’s global digital pathology business, which is based in Tampa, Florida. Inspirata’s Dynamyx® digital pathology technology, staff, and clients will join Fujifilm upon the conclusion of this agreement. 

The inclusion of digital pathology will broaden Fujifilm’s strong Synapse® Enterprise Imaging portfolio, enabling the integration of pathology data and images into an organization’s electronic health record system and aiding in the streamlining of care for oncology patients and provider teams.

This acquisition represents Fujifilm’s full-scale, global entry into the largely untapped digital pathology market, where 85% of U.S., 86% of European, and 90% of Asian healthcare organizations are still using analog technology. Fujifilm will build on the success of its established partnership with Inspirata.

An open, vendor-neutral, end-to-end digital pathology solution is Dynamyx. With the help of whole slide images from various scanning vendors, more pathology labs can digitize and benefit from quicker patient results, centralized imaging records, and enterprise access to images for all clinicians thanks to Dynamyx’s software capabilities. It is installed in healthcare facilities that deal with large volumes of pathological images from various lab locations, enabling them to use their preferred combination of laboratory and diagnostic technologies with full confidence in compatibility.

Future Dynamyx releases will also give Fujifilm the chance to assist pharmaceutical and contract research organizations with the management of toxicity testing data for drug development.

Several international healthcare organizations have successfully implemented these advantages thanks to Fujifilm’s current partnership with Inspirata.

Teiichi Goto, president, CEO, and representative director, of FUJIFILM Corporation, said, “Acquiring Inspirata’s digital pathology business allows Fujifilm to be an even stronger healthcare partner – bridging a technological gap between pathology, radiology, and oncology to facilitate a more collaborative approach to care delivery across the enterprise. We’re thrilled to welcome Inspirata’s digital pathology experts to Fujifilm’s growing medical informatics business, along with their renowned global customer base, as together we work to drive the digitization and advancement of healthcare.”According to DelveInsight’s the global digital pathology market is expected to grow at a CAGR of 11.20% during the forecast period from 2022 to 2027. Factors such as the increasing adoption of digital pathology to enhance lab efficiency, the rising incidence of cancer, and the growing applications of digital pathology in drug development and companion diagnostics. Moreover, the introduction of affordable scanners for private pathology practices has opened better opportunities for digital pathology market growth, which is expected to drive the global digital pathology market during the forecast period of 2022-2027.