Table of Contents
Epredia Announced the US Launch of SlideMate™ Laser, Providing State-of-the-Art Precision Slide Printing for Pathology Laboratories
On January 11, 2024, Epredia, a global leader in precision cancer diagnostics, announced that the company launched US sales of SlideMate™ Laser, the newest addition to the company’s SlideMate portfolio of slide printers, which are used in pathology laboratories to identify and help track tissue samples.
For clinical laboratories of any size seeking to enhance sample traceability, Epredia created SlideMate Laser. SlideMate Laser allows labs to print more identifying information right on the tab of the slides that pathologists utilize in the cancer detection workflow. This high-resolution, 600-dpi laser printing on microscope slides makes this possible. This technology helps to increase patient sample monitoring and efficiency by embedding up to 50 characters in a barcode on each slide, as opposed to the 23 characters that may be found in typical thermal transfer and ink jet technologies.
By streamlining slide motions through the printer and minimizing possible downtime in comparison to thermal transfer and ink jet printers, SlideMate Laser significantly improves laboratory productivity. Users can anticipate reduced operating costs because slide printers don’t require the purchase of ink, bulbs, or tape. SlideMate Laser can be integrated into a variety of processes because it offers both batch and on-demand printing possibilities. A Laboratory Information System can be immediately interfaced with by using the user-friendly software of the laser printer.
The newest offering in Epredia’s exclusive line of precision cancer diagnostics goods and services, which offer a smooth, end-to-end laboratory workflow, is SlideMate Laser. To assist labs in seamlessly converting to precision laser printing, Epredia also provides the specific slides made for SlideMate Laser. To optimize tissue adherence, this comprises adhesion slides with Superfrost PLUSTM technology and non-adhesion slides with SuperfrostTM technology. There are five different colors of slides that labs can use to plan activities that come next.
The firm that makes SlideMate Laser is Fa-Tech Diagnostics Italia SRL, which was purchased by PHC Holdings Corporation in 2021. Fa-Tech Diagnostics Italia SRL is based in San Benedetto del Tronto, Italy. Epredia makes all of the SlideMate Laser slides at its Portsmouth, New Hampshire facility in the United States.
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 to develop 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.
Olympus, Canon Medical Announced Partnership on Endoscopic Ultrasound
On January 16, 2024, Canon Medical and Olympus announced that they reached an agreement to collaborate on endoscopic ultrasound technology.
As per the agreement, Canon will create and produce endoscopic ultrasound (EUS) diagnostic ultrasound. Olympus is in charge of the partnership’s marketing and sales initiatives.
Both an Olympus ultrasound endoscope and a Canon Aplio i800 diagnostic EUS ultrasound are used in the transaction. Canon and Olympus want to offer cutting-edge EUS technology to the market so that it can diagnose images with superior quality. The companies want to concentrate on improving diagnostic performance and developing new technologies. They intend to collaborate on global expansion, starting in Europe and Japan.
Canon’s strengths are its excellent ultrasound image quality and patented technology, according to a news statement. Olympus provides minimally invasive treatments, staging, early detection, and diagnosis. The companies anticipate that the partnership will result in significant gains in image quality as well as enhanced diagnostic and therapeutic capabilities of EUS.
Toshio Takiguchi, Canon Medical president and CEO said, “The collaboration helps the company cover the EUS field. Takiguchi added, “Previously, the company failed to cover it adequately “until now.” Now, this collaboration can “deliver superior solutions to more patients.”
“Olympus aims to improve patient’s quality of life through early diagnosis made available with endoscopic ultrasound systems,’ said Frank Drewalowski, executive officer and endoscopic solutions division head at Olympus. Frank commented, “In the field of EUS, diagnostic ultrasound systems are very important, and we are pleased to have a cooperative relationship with Canon Medical, which has advanced ultrasound imaging technology. Canon Medical and Olympus will continue to introduce products and technology that address the needs of the patients, healthcare professionals, and the broader medical industry.”
As per DelveInsight’s “Endoscopic Ultrasound Market” report, the global endoscopic ultrasound market is estimated to grow at a CAGR of 9.28% during the forecast period from 2023 to 2028. The continuously rising prevalence of gastrointestinal diseases worldwide is one of the primary reasons for the growth of the endoscopic ultrasound market. Further, rising awareness about health, and technological advancement in the product line, among others.
FDA Cleared Painful Diabetic Neuropathy Neurostim Therapy from Neuralace
On January 11, 2024, Neuralace Medical announced that it received US Food and Drug Administration (FDA) clearance for its chronic painful diabetic neuropathy (PDN) treatment.
Based in San Diego According to Neuralace, this is the first time a non-invasive magnetic peripheral nerve stimulation (mPNS) treatment for PDN has been approved by the FDA.
According to Neuralace, Axon Therapy uses mPNS to provide a rapid, painless, and non-invasive treatment in sessions that only take 13.5 minutes. Magnetic pulses are used in each session to relieve pain and possibly enhance pain management.
According to Neuralace, a recent trial comprising 71 patients showed efficacy along with notable enhancements in subject outcomes. The company thinks that the way PDN is treated has changed dramatically with its medicine.
Axon Therapy is a non-invasive, non-pharmacological alternative that may lessen reliance on prescription drugs and the negative consequences they cause. According to the business, FDA approval opens the door for more people to have access to cutting-edge pain management techniques.
“The FDA clearance of Axon Therapy is a monumental step forward in the treatment of PDN,” said Keith Warner, CEO of Neuralace Medical. Keith added, “This first-of-its-kind, non-invasive solution embodies our commitment to innovative, patient-centered care, offering effective pain relief without the drawbacks of conventional, more invasive treatments.”
“For more than eight years, our Micra leadless pacemakers have provided meaningful benefits to people in Europe who require a pacemaker. Now, these patients have access to the latest leadless pacing technology that, for most of them, maybe the only device they will ever need,” said Robert C. Kowal, M.D., Ph.D., general manager, Cardiac Pacing Therapies within the Cardiac Rhythm Management business, which is part of the Cardiovascular Portfolio at Medtronic.
“The first generation of leadless Micra pacemakers demonstrated a significant reduction in major complications, and this next generation of Micra brings several additional benefits including greater longevity, and specifically for the Micra AV2, new algorithms to optimize AV synchrony at faster heart rates while requiring less in-office programming,” said Prof. Dr. Christophe Garweg, Cardiologist at University Hospitals of Leuven, Belgium. He added further, “These advantages likely will expand the use of the leadless pacemaker to more patients.”
According to DelveInsight’s “Peripheral Nerve Stimulators Market” report, the global peripheral nerve stimulators market is estimated to grow at a CAGR of 6.9% during the forecast period from 2023 to 2028. The increase in demand for Peripheral Nerve Stimulators is primarily attributed to the increase in number of patients suffering from nerve injuries, effective technologies in PNS, growing awareness of peripheral nerve stimulators among people, chronic pain management therapies, increased prevalence of disease which can drive pain, increasing geriatric population, rising of obese population, growing public awareness about PNS, are anticipated to bolster the market growth, thereby contributing to the growth of the Peripheral Nerve Stimulators market during the forecast period from 2023-2028.
Bloomlife Announced US FDA Clearance of Bloomlife MFM-Pro
On January 16, 2024, Bloomlife, the award-winning maternal health company, received clearance from the US Food and Drug Administration (FDA) for Bloomlife MFM-Pro, their first maternal and fetal monitoring device.
Following Bloomlife’s collaboration with Perigen to enhance critical monitoring of high-risk pregnancies, this announcement was made. The prescription-based Bloomlife MFM-Pro wearable is intended to assist medical professionals in taking maternal and fetal heart rates in clinics or at the patient’s home. With cloud-based processing, the device detects the body’s electrical activity non-invasively and uses an algorithm to extract the heart rates of the mother and fetus. A significant turning point in their move from the consumer to the medical markets has been reached with the FDA clearance. Bloomlife has led the way in innovative maternal health care since its founding. The Bloomlife Pregnancy Tracker, a wearable patch-based gadget that tracks and times contractions automatically, is what initially made the brand well-known.
The consumer product received praise from the mom and tech communities and was recognized with several design and innovation awards, such as the BUMP Best of BabyTech, CLIO, and CES Innovation Awards. In addition to receiving the Johnson and Johnson Innovation Award and Fast Company World Changing Ideas, the company’s vision to use the device to aggregate unique longitudinal data to address large intractable difficulties in the maternal health domain, such as preterm birth, led to more accolades. With the intention of creating a comprehensive remote maternal health platform to help doctors better screen and manage the rising incidence of pregnancy issues, the company changed its emphasis in 2020 and began concentrating on the medical sectors.
According to Bloomlife, technology can help alleviate the global crisis in maternal health.
The mission of Bloomlife is to employ technology to provide patient-centered, evidence-based, low-cost, high-quality care in the home, replacing expensive clinical settings. The organization is making great progress toward its goal of improving the health of mothers and newborns worldwide, as seen by its most recent accomplishments.
“Our pioneering consumer pregnancy tracker proved that women want access to more information during a pivotal time of her life. The FDA clearance of Bloomlife MFM-Pro marks an important milestone by cementing our transition from consumer to medical markets”, said Eric Dy PhD, Co-Founder and CEO of Bloomlife.
According to DelveInsight’s “Fetal and Neonatal Monitoring Devices Market” report, the global fetal and neonatal monitoring devices market is estimated to grow at a CAGR of 12.77% during the forecast period from 2023 to 2028. The demand for fetal and neonatal monitoring devices is motivated by the increasing application of these devices to assist preterm newborns. The need for neonatal and fetal monitors is expected to increase in the near future due to the increase in the frequency of twins and triplets as a result of the increased use of reproductive treatments in multiple pregnancies that result in premature birth. The market is now being greatly accelerated by technical advancements and developments, which in turn are driving up demand for these devices.
BrainsWay Initiated New Studies of Non-Invasive Neurostim
On January 11, 2024, BrainsWay announced its plans for two new feasibility trials evaluating its neurostimulation technology.
BrainsWay’s proprietary rotational field TMS (also known as Deep TMS 360°) is used in both investigations. More brain neurons can be activated by the company’s transcranial magnetic stimulation (TMS) type of stimulation.
There are two orthogonal TMS coils positioned perpendicular to each other in the new rotational field system that is being evaluated. They create a revolving electric field that circulates when operated slowly. As a result, neurons in the targeted brain region that are positioned in a wide range of directions receive consistent stimulation. Everything happens in a nanosecond or less.
BrainsWay intends to conduct two further trials to evaluate the technology’s possible clinical impact. One evaluates the effectiveness and safety in the field of stroke recovery. The other uses an accelerated technique to examine obsessive-compulsive disorder (OCD). The FDA has previously approved BrainsWay’s Deep TMS for OCD use utilizing its H7 coil and the regular daily procedure. In this new study, the possibility that rotational field stimulation could shorten the duration of traditional treatment while improving results is evaluated.
“We are proud to continue to be at the forefront of innovation in the field of noninvasive brain stimulation,” said Hadar Levy, BrainsWay CEO. “We believe that our rotational field technology holds significant potential to change the current TMS paradigm.”
According to DelveInsight’s “Neurostimulation Devices Market” report, the global neurostimulation devices market was valued at USD 5.82 billion in 2022, growing at a CAGR of 11.77% during the forecast period from 2023 to 2028, to reach USD 11.34 billion by 2028. The demand for neurostimulation devices is primarily motivated by the increasing incidence of chronic neurological diseases, such as migraine and epilepsy, escalating product demand as add-on therapy, the prevalence of lifestyle diseases such as depression and chronic pain, the adoption of technologically advanced products, and rising geriatric population among others during the forecast period.
Gore Enrolled First Patients in Expandable Stent Graft Trial
On January 16, 2024, W.L. Gore & Associates announced that it enrolled the first patients in a trial evaluating its Viabahn VBX stent graft.
For patients with complex iliac occlusive illness, the trial contrasts bare metal stenting with Gore’s balloon-expandable endoprosthesis. The best modalities for patients with this ailment are intended to be informed by it in order to create practice guidelines.
Among the first to enroll patients were Dr. Fakhir Elmasri and his colleagues at the Lakeland Vascular Institute in Lakeland, Florida. According to Elmasri, an interventional radiologist, the findings should guide the choice of device for long-term effects going forward. According to Dr. Prakash Krishnan of Mount Sinai in New York, the study may provide an answer to the query regarding superior modalities.
Gore intends to enlist about 244 participants at 40 locations throughout the United States, Europe, Australia, and New Zealand. Patients are randomized 1:1 in the trial to either the bare metal stenting control group or the VBX stent graft group. A press release states that a five-year follow-up is part of the study following the initial operation.
According to Gore, the VBX stent graft provides accurate distribution and promotes successful outcomes in intricate aortoiliac applications.
“Today marks important progress in our continuing effort to raise the bar on endovascular treatment outcomes that demonstrate a positive impact on the lives of patients who suffer from this disease,” said Eric Zacharias, medical products division leader, W. L. Gore & Associates. “Not only can the results from this randomized controlled trial help determine which stent choice demonstrates better patency in patients with complex iliac occlusive disease, but it also aims to provide the quality of evidence necessary to inform practice guideline recommendations.”
According to DelveInsight’s “Coronary Stents Market” report, the global coronary stents market was valued at USD 9.27 billion in 2022, growing at a CAGR of 7.51% during the forecast period from 2023 to 2028, to reach USD 14.28 billion by 2028. The rise in demand for coronary stents is primarily attributed to the rising prevalence of cardiovascular disorders such as stroke, atherosclerosis, and heart attack due to the increasing geriatric population; a growing number of PCI (Percutaneous Coronary Intervention) procedures; increase in demand for minimally invasive surgeries, and technological advancement in the product line, among others.