Roche Digital Pathology Dx was designed to assist pathologists in reviewing and interpreting digital images of scanned pathology slides prepared from formalin-fixed paraffin-embedded (FFPE) tissue for patient diagnoses.
“The VENTANA DP 600 high-capacity slide scanner creates high-resolution, digital images of stained tissue samples that help clinicians diagnose cancer and determine a patient’s treatment,” said Jill German, Head of Pathology Lab for Roche Diagnostics. “The recent FDA clearances continue our momentum to advance the pathology lab’s digital transformation and reinforce our commitment to enhance patient care and healthcare efficiency through streamlining the digital workflow.”
As per DelveInsight’s “Diagnostic Imaging Equipment – Market Insights, Competitive Landscape, and Market Forecast – 2030”, the global diagnostic imaging equipment market was valued at USD 24.15 billion in 2023 growing at a CAGR of 5.10% during the forecast period from 2024 to 2030, to reach USD 33.56 billion by 2030. The demand for diagnostic imaging equipment is primarily attributed to the rising technological advancement, growing burden of chronic diseases, increasing patient awareness regarding early-stage diagnosis, growing demand for effective & efficient imaging technologies for diagnosis, and increasing geriatric population.
Pacira BioSciences Received FDA 510(k) Clearance for its new Iovera° SmartTip, Designed to Manage Chronic Low Back Pain Through a Long-Lasting Medial Branch Nerve Block
On January 07, 2025, Pacira BioSciences, Inc., a leading provider of innovative non-opioid pain therapies, announced that it received clearance from the U.S. Food & Drug Administration (FDA) to market a Smart Tip designed for accessing the medial branch nerves to manage chronic low back pain.
The iovera system was an innovative, FDA-cleared, drug-free treatment that relieved pain through cryoneurolysis—a process in which focused cold therapy was applied to a targeted nerve, temporarily interrupting its ability to transmit pain signals. Pain relief was typically experienced immediately after treatment, with effects lasting for months as the nerve gradually regenerated.
Previously, the iovera portfolio included either a three-pronged Smart Tip featuring 8.5-mm long 27-gauge needles for treating superficial nerves or a single, 90-mm long, 20-gauge Smart Tip suited for deeper nerves. It was most commonly used to treat knee pain but was also frequently employed to manage pain in the hip, shoulder, chest, foot, ankle, and other areas.
A new 25-gauge, 180-mm Smart Tip was later introduced, enabling the treatment of deeper nerves such as the medial branch nerve. It was specifically designed to relieve chronic low back pain associated with facet-mediated pain. This longer-needle Smart Tip was uniquely constructed for use through a cannula or introducer, facilitating ice ball formation at deeper peripheral nerves.
“The FDA clearance of this new iovera° Smart Tip is a pivotal step forward, offering patients an innovative, drug-free solution that delivers meaningful and lasting pain relief” said Jonathan Slonin, MD, Chief Medical Officer of Pacira BioSciences. “This achievement reflects our dedication to improving quality of life for the millions of Americans living with chronic back pain.”
As per DelveInsight’s “Spinal Cord Stimulators – Market Insights, Competitive Landscape, and Market Forecast – 2030”, the global spinal cord stimulators market size was valued at USD 2.25 billion in 2023, growing at a CAGR of 8.70% during the forecast period from 2024 to 2030 to reach USD 3.72 billion by 2030. 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 patient discomfort, with no side effects are likely responsible for a boost in the global spinal cord stimulators market growth. Moreover, favorable government regulations for commercialization and launching products in the market and the rising geriatric population are some of the factors responsible for propelling the growth of the spinal cord stimulators market.
ClearCut Medical Announced the Results of a Post-Marketing Clearcoast™ Study, Presented at the San Antonio Breast Cancer Symposium
On January 08, 2025, ClearCut Medical, a commercial-stage privately held company, developed the ClearCoast™, the first and only portable MRI system designed to perform real-time intraoperative margin assessment of excised breast tumors during Breast Conserving Surgery (BCS). Clear margins were critical for minimizing the risk of recurrence and the need for retreatment.
The ClearCoast™ portable MRI system, which provided surgeons with real-time information on margin assessment during Breast Conserving Surgery, was developed by ClearCut Medical Ltd.
The study primarily aimed to compare retreatment proportions within and between study groups in accordance with the SSO-ASTRO guideline. The secondary endpoint compared the diagnostic ability of ClearCoast™ and the Standard of Care (SoC) to detect positive margins intraoperatively, as well as the total excised breast tissue volume between study groups.
“ClearCoast™ is the most promising technique currently available for intraoperative margin assessment in breast conserving surgery of in situ and invasive breast cancer” said Prof. Dr. Marc Thill, director of the Department of Gynecology and Gynecological Oncology at the Agaplesion Markus Hospital in Frankfurt, Germany and PI of the study. “Following previous trials and after using the technique in our interventional post-marketing ClearCoast™ study, I am convinced that the technique is ready for clinical routine.”
According to DelveInsight’s “Breast Reconstruction – Market Insights, Competitive Landscape, and Market Forecast – 2030”, the global breast reconstruction market was valued at USD 554.50 million in 2023, growing at a CAGR of 6.54% during the forecast period from 2024 to 2030 to reach USD 810.14 million by 2030. The breast reconstruction market is witnessing positive growth owing to various factors such as the increasing prevalence of breast cancer, increase in the number of cosmetic & reconstructive surgeries, surge in the launch of technologically advanced breast reconstruction products, and factors such as aging, race, & ethnicity drives the breast reconstruction demand. Therefore, the market for breast reconstruction is estimated to grow at a significant CAGR during the forecast period from 2024 to 2030.
NanoVibronix Announced the Completion of Pilot Phase of Clinical Study of UroShield® at the University of Michigan
On January 06, 2025, NanoVibronix, Inc., a medical device company specializing in the UroShield®, PainShield®, and WoundShield® Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, announced the successful completion of the first phase of a Randomized Control Trial study of UroShield® conducted by researchers at the University of Michigan (“UM”).
This initial phase of the trial served as a precursor to the full study by UM researchers. It was carried out primarily with nursing home residents and focused on evaluating the impact of UroShield® on improving patients’ quality of life by potentially reducing urinary tract infections, catheter blockages, and pain associated with the long-term use of urinary catheters.
Brian Murphy, Chief Executive Officer of the Company, commented, “The first phase of the study served as a validation pilot in advance of a full study. With this phase now complete, researchers at UM can advance to the next phase, a full Randomized Control Trial of additional patients. We expect the full trial to commence in 2025.”
Mr. Murphy continued, “The validation our products continue to receive from independent research and the progress we are making towards further commercializing UroShield is highly encouraging. This research builds on previously concluded studies and product launches in the U.K., Australia and New Zealand and our recent introduction of UroShield to the European market. The next phase of the UM study is expected to be conducted concurrently with our preparations for the launch of UroShield in the U.S., subject to 510K clearance with the U.S. Food and Drug Administration.”
According to DelveInsight’s “Urology Devices – Market Insights, Competitive Landscape, and Market Forecast – 2030”, the urology devices market was valued at USD 9.17 billion in 2023, growing at a CAGR of 6.78% during the forecast period from 2024 to 2030 to reach USD 13.56 billion by 2030. The urology devices market is growing significantly due to the increasing cases of chronic disorders including cancers and benign prostatic hyperplasia (BPH), rising geriatric population prone to such conditions, technological advancements in product development, growing preference of minimally invasive procedures that are expected to escalate the demand for urology devices during the forecast period from 2024 to 2030.
Hologic Completed the Acquisition of Gynesonics, Inc.
On January 06, 2025, Hologic, Inc., a global leader in women’s health, completed its previously announced acquisition of Gynesonics, Inc. (Gynesonics®), a privately held medical device company specializing in minimally invasive solutions for women’s health, for approximately $350 million.
The Sonata System is a technology designed for diagnostic intrauterine imaging and the transcervical treatment of certain symptomatic uterine fibroids, including those associated with heavy menstrual bleeding. It combined real-time intrauterine ultrasound guidance with targeted radiofrequency ablation in an incisionless procedure.
“We are excited to complete the acquisition of Gynesonics and to increase access to their Sonata® System, which complements and expands our range of minimally invasive solutions for heavy periods and fibroids,” said Brandon Schnittker, President of Surgical Solutions at Hologic. “As global champions for women’s health, we are dedicated to empowering surgeons with diverse, cutting-edge treatment options as we strive to transform women’s lives for the better.”
“As we embark on this new phase with Hologic, we are excited to see the continued success of the Sonata System, which has already made a difference in the lives of thousands of women,” said Skip Baldino, President and Chief Executive Officer of Gynesonics. “Hologic’s commitment to women’s health and their leadership in innovation make them a perfect fit for our organization.”
According to DelveInsight’s “Gyneco-Obstetric Ultrasound Systems – Market Insights, Competitive Landscape, and Market Forecast – 2030”, the gyneco-obstetric ultrasound systems market was valued at USD 2.68 billion in 2023, growing at a CAGR of 5.70% during the forecast period from 2024 to 2030, in order to reach USD 3.73 billion by 2030. The gyneco-obstetric ultrasound systems market is witnessing positive growth owing to factors such as the increasing instances of gynecological disorders such as pregnancies, ovarian cysts, fibroids, polycystic ovary syndrome, endometriosis and others, advancements in technology, and the increasing demand for comprehensive reproductive health monitoring among others that are acting as major factors driving the growth of the gyneco-obstetric ultrasound systems market during the forecast period from 2024 to 2030.
Movano Health Launched EvieAI Virtual Wellness Assistant
On January 08, 2025, Movano Health announced the latest enhancement to its Evie smart ring for women with the beta release of EvieAI, the first wearable-based virtual wellness assistant trained exclusively with data from medical journals. The new feature enabled Evie users to answer health questions quickly, reliably, and securely through the ring’s companion app.
Planned future integration with Evie data was set to allow EvieAI’s responses to be personalized based on users’ own health metrics, including heart rate, blood oxygen, menstrual cycle information, skin temperature variability, sleep, exercise, and mood captured by Evie’s sensors and user logs.
Unlike general-purpose digital assistants like ChatGPT, which are trained using public data, EvieAI generated clear and concise answers based on articles published in over 100,000 medical journals and written by medical professionals. This helped ensure accuracy and the ability to interpret complex user queries about almost any symptom, disease, condition, or procedure.
Evie’s new virtual assistant also followed industry-standard encryption protocols to ensure that all user data, including sensitive health information, was protected during storage and transmission. This included confidentiality protections ensuring that chats could not be traced back to individual users.
“Our vision for the Evie Ring has always been to provide insights that can help users navigate their personal wellness journeys,” said Tyla Bucher, Chief Marketing Officer at Movano Health. “EvieAI marks a significant leap forward in helping us fulfill that vision.”
According to DelveInsight’s “Women’s Health – Market Insights, Competitive Landscape, and Market Forecast – 2030”, the global women’s health market was valued at USD 31.94 billion in 2023, growing at a CAGR of 5.40% during the forecast period from 2024 to 2030 to reach USD 43.76 billion by 2030. The women’s health market is slated to witness prosperity owing to factors such as the growing prevalence of breast cancer, further rise in menstrual disorders and infertility issues in women, and the growing focus on improving the safety, affordability, and usability of women’s health products are further expected to result in the appreciable revenue growth in the women’s health market during the forecast period from 2024 to 2030.
