QT Imaging Secures FDA Clearance for Enhanced Breast Acoustic CT Scanner Configuration; LifeVac Secures FDA Authorization as the First and Only Anti-Choking Device; Smith+Nephew Introduces Next-Generation ALLEVYN COMPLETE CARE Foam Dressing for Enhanced Wound Management; Olympus Corporation Debuts Next-Gen Surgical Visualization Platform in the U.S.; IceCure Medical Receives FDA Approval for Post-Marketing ‘CHOICE’ Study of ProSense Cryoablation System; Envoy Medical Concludes Enrollment for Landmark Trial of Fully Implanted Cochlear Implant

QT Imaging Received FDA Clearance for its Breast Acoustic CT Scanner Enhanced Configuration to Improve Posterior Breast Imaging Coverage 

On 10 March 2026, QT Imaging Holdings, Inc., a medical device company focused on advancing breast health management through innovative radiation-free imaging technology, announced that it had received 510(k) clearance from the U.S. Food and Drug Administration for an updated configuration of its Breast Acoustic CT™ scanner, the company’s 3D ultrasound tomographic breast imaging system. The newly cleared enhanced configuration improved visualization and expanded coverage of posterior breast tissue.

The QTI Breast Acoustic CT scanner generated both reflection-mode and transmission-mode ultrasound data to reconstruct 3D tomographic images. Its proprietary software quantified fibroglandular tissue volume (FGV) and the ratio of fibroglandular tissue to total breast volume (TBV), offering valuable insights for breast health assessment and ongoing monitoring.

“The updated configuration cleared by the FDA incorporates a tilted transmitter geometry that improves tomographic imaging coverage of breast tissue located near the chest wall, which is an area that can be extremely challenging to capture,” said Bilal Malik, PhD, Chief Science Officer of QT Imaging. “This design delivers more complete coverage and improved overall diagnostic utility by optimizing the scanner’s ability to include posterior breast tissue that is often difficult to image with standard approaches. We remain dedicated to developing and refining innovative technologies that provide greater precision and confidence to deliver the best outcomes for women regardless of breast density.”

As per DelveInsight’s “Breast Cancer Diagnostics Market Report,” the global breast cancer diagnostics market was valued at USD 4.20 billion in 2023, growing at a CAGR of 6.67% during the forecast period from 2024 to 2030 to reach USD 6.16 billion by 2030. The breast cancer diagnostics market is witnessing a positive growth owing to the factors such as increasing prevalence of breast cancer, increasing age and sedentary lifestyle, technological advancements, government initiatives to increase the rate of screening and diagnosis, thereby all factors contributing to the growth of the breast cancer diagnostics market during the forecast period from 2024 to 2030.

LifeVac Became the First and Only FDA-Authorized Anti-Choking Device

On 6 March 2026, LifeVac LLC announced that the U.S. Food and Drug Administration had granted De Novo classification for its LifeVac under 21 CFR 874.5400, formally establishing the device category “suction anti-choking device as a second-line treatment.”

Under the order, LifeVac was classified as a Class II medical device. The FDA defined this device type as one intended to resolve choking caused by complete airway obstruction through the application of suction and to be used as a second-line intervention in emergencies after basic life support (BLS) choking protocols had been attempted unsuccessfully.

The cleared indications stated that LifeVac was a non-powered, non-invasive, single-use airway clearance device designed for both adult and pediatric choking victims aged one year and older. The device could be used by laypersons or medical professionals aged 18 years or older in various settings, including homes, nursing homes, restaurants, and schools. The FDA determined that the Class II classification, along with general and special regulatory controls, provided reasonable assurance of the device’s safety and effectiveness for its intended use.

“As stated in the order, LifeVac is intended to be used after a BLS choking protocol fails,” said Arthur Lih, Founder and CEO of LifeVac. “This classification creates a clear regulatory framework for suction anti-choking devices used as a second-line treatment.”

As per DelveInsight’s “Airway Management Devices Market Report,” the global airway management devices market size is projected to increase from USD 1.60 billion in 2023 to USD 2.29 billion by 2032, reflecting strong and sustained growth. The global airway management devices market is expected to grow at a CAGR of 6.21% during the forecast period from 2025 to 2032. Rising cases of asthma, COPD, and airway disorders, along with growing surgical procedures and worsening air pollution, are boosting demand for advanced airway management devices. Increased awareness, early diagnosis, and new product launches further drive market growth.

Smith+Nephew Launched Next-Generation ALLEVYN COMPLETE CARE Foam Dressing – Designed For High Performance In Wound

On 10 March 2026, Smith+Nephew, a global medical technology company, announced the launch of ALLEVYN COMPLETE CARE Foam Dressing, which incorporated proprietary technologies and demonstrated performance supported by a strong portfolio of scientific data and clinical evidence. The dressing featured a unique five-layer construction with distinct mode-of-action technologies designed to support both wound management and the prevention of pressure injuries.

The product was developed to help minimize leakage and disruption by reducing the frequency of dressing changes while also protecting vulnerable skin—key factors in effective wound care management. Global estimates indicated that up to one in 50 adults experienced chronic wounds during their lifetime, often leading to delayed healing and complications that affected daily life. Additionally, studies reported that up to one in 10 hospitalized patients developed pressure injuries, with hospital-acquired pressure injuries linked to an average of 9.5 additional days of hospital stay. These conditions continued to place a significant burden on the broader healthcare system.

Rohit Kashyap, President of Advanced Wound Management at Smith+Nephew, said “ALLEVYN COMPLETE CARE is a true next-generation dressing that reflects our continued commitment to wound care innovation, delivering meaningful benefit where it matters most. Every dressing is designed for strong performance in both wound treatment and pressure injury prevention, helping patients get back to what they love, whilst reducing the costly and complex clinical burden.” 

As per DelveInsight’s “Advanced Wound Care Market Report,” the advanced wound care market was valued at USD 9.45 billion in 2023, growing at a CAGR of 10.51% during the forecast period from 2025 to 2032, to reach USD 16.97 billion by 2032. The advanced wound care market is expanding rapidly due to the collective impact of rising chronic and acute wound prevalence, such as diabetic ulcers and pressure sores, increasing surgical procedures, and the growing product launches and approvals by key market players is expected to significantly drive the demand for advanced wound care from 2025 to 2032.

Olympus Launched Next-Generation Surgical Imaging Platform in U.S.

On 11 March 2026, Olympus Corporation announced the U.S. launch of the VISERA ELITE III surgical imaging platform, which was designed to enhance surgical visualization, improve workflow efficiency, and provide multispecialty flexibility. The VISERA ELITE III platform represented a significant advancement in surgical imaging and marked the third major co-developed product by Sony Olympus Medical Solutions Inc., a joint venture established in 2013 between Olympus and Sony Group Corporation.

The platform was developed to deliver enhanced light, color, and clarity inside the human body by integrating advanced imaging technologies into a software-driven system that supported minimally invasive surgery across multiple specialties. Its next-generation features included True 4K and 3D imaging, Continuous Auto Focus (CAF), Narrow Band Imaging (NBI), Yellow Enhancement (YE), ENDOEYE videoscopes, and Fluorescence-Guided Surgery (IR/ICG) capabilities, available in full 4K White Light and high-contrast Magenta Mode. These technologies were integrated into a single system designed to streamline surgical workflows and support clinical decision-making.

The versatile, multispecialty VISERA ELITE III platform supported a broad range of surgical areas, including arthroscopy, colorectal, ENT, bariatric, thoracic, gynecological, urological, HPB transplant, and general surgery. Its compatibility with prior-generation video endoscopes reflected Olympus’ focus on providing scalable clinical solutions that could evolve alongside the needs of surgical teams.

“VISERA ELITE III is more than a platform it’s a strategic enabler for modern operating rooms and is a cornerstone of Olympus’ SEE. TREAT. CONNECT™ ecosystem,” said Darryl Rock, Vice President and Surgical Solutions Regional Business Lead at Olympus Corporation of the Americas. “Its software-based architecture allows hospitals to scale capabilities while controlling capital investment and selectively activate advanced features like 3D and infrared imaging as needed. By seamlessly integrating data into electronic health records and IT systems, VISERA ELITE III may facilitate flexibility and clinical workflow and enable clinicians to focus on what matters most delivering high-quality care while optimizing their investment.”

According to DelveInsight’s “Minimally Invasive Surgical Devices Market Report”, the global minimally invasive surgical devices market is expected to increase from USD 30,798.01 million in 2025 to USD 53,259.85 million by 2034, reflecting strong and sustained growth. The market of minimally invasive surgical devices is being primarily driven by the rising prevalence of chronic diseases such as cancer, cardiovascular disorders, increasing technological advancement in surgical devices, and an increase in product development activities among the key market players globally.

U.S. FDA Approved Icecure’s Post-Marketing “Choice” Study for Prosense® Cryoablation in the Local Treatment of Low-Risk Breast Cancer 

On 11 March 2026, IceCure Medical Ltd., a developer of minimally invasive cryoablation technology for destroying tumors by freezing as an alternative to surgical removal, announced that the U.S. Food and Drug Administration had approved the study design for the “ChoICE Trial Post-Market Study”, the company’s post-marketing study for ProSense® in the treatment of low-risk breast cancer. Patient enrollment was expected to begin in the second half of 2026, with at least 80 patients anticipated to be enrolled in the first year of the study.

The FDA had previously granted marketing authorization in October 2025 for ProSense® to treat patients aged 70 years and older with biologically low-risk tumors ≤1.5 cm in size, provided they received adjuvant endocrine therapy. As part of this authorization, the FDA requested that IceCure conduct a post-market surveillance study to generate additional real-world data on the use of ProSense® for this indication. The study was projected to enroll and treat approximately 400 patients across 30 U.S. clinical sites over 36 months. IceCure had already received interest and engagement from leading medical institutions nationwide seeking to participate in the study.

Under the approved study design, participating sites were to treat enrolled patients while also serving as active commercial sites, providing cryoablation to patients outside the study and supporting the company’s commercial expansion. The study was planned to be conducted using cryoprobes sold exclusively by IceCure, with participating facilities able to utilize an established CPT Category III reimbursement code.

“We believe the combination of FDA marketing authorization, this FDA-approved post-market study with 30 clinical sites across the country, supportive American Society of Breast Surgeons (‘ASBrS’) guidelines, an established reimbursement code, and strong physician engagement positions us to meaningfully expand access to ProSense® as a minimally invasive treatment option for eligible breast cancer patients across the U.S.,” stated Eyal Shamir, Chief Executive Officer of IceCure. “We are also very pleased to work with two leading thought leaders in breast cancer treatment, Dr. Robert Ward and Dr. Nathalie Johnson, who will be Co-Principal Investigators of the Study.”

According to DelveInsight’s ”Cryoablation Devices Market Report,” the global cryoablation devices market is estimated to advance at a CAGR of 8.8% during the forecast period from 2024 to 2030. The demand for cryoablation devices is primarily being boosted by the rising number of patients suffering from cardiovascular disorders, the increase in the number of patients suffering from chronic disorders such as cancer, the higher availability of customized probes for cryoablation, the increasing technological advancements associated with the cryoablation devices will help in contributing in the overall market growth of the cryoablation devices during the forecast period from 2024 to 2030.

Envoy Medical Completed Enrollment of Pivotal Clinical Trial Evaluating First-of-its-Kind Fully Implanted Cochlear Implant 

On 11 March 2026, Envoy Medical® Inc. announced that it had completed enrollment in its pivotal clinical trial for the investigational fully implanted Acclaim® cochlear implant. With the successful implantation of the 56th and final patient, Envoy Medical became the first cochlear implant company to achieve full enrollment of a U.S. pivotal clinical trial evaluating a fully implanted cochlear implant seeking FDA approval.

Following completion of enrollment, the study proceeded through scheduled follow-up visits and data collection in accordance with the trial protocol. Once 12-month follow-up data had been collected for all patients, the data was to be analyzed and submitted to the U.S. Food and Drug Administration as part of a PMA application seeking approval. Subject to FDA review and approval, commercialization in the United States was expected to follow.

Envoy Medical held that it was the first cochlear implant manufacturer to complete enrollment in a U.S. pivotal trial for a fully implanted cochlear implant, positioning the company at the forefront of this next generation of hearing technology.

“Participating in the Acclaim Cochlear Implant Pivotal Trial has been an eye opener for me,” Dr. Antonelli shared, “I’ve been placing traditional cochlear implants for so long-over 30 years-and these devices evolved so little over that time that I didn’t give much thought to how dramatically they could be improved. The Acclaim changed that.”

Dr. Antonelli continued, “People with profound hearing loss desperately want to be able to hear 24 x 7 without having to wear an external processor. Others have been reluctant to get a cochlear implant because of the stigma they feel with an external processor. I think just about every Acclaim recipient that we’ve enrolled in this study said, often tearfully, ‘you’ve really made my day,’ when I told them they were cleared to get the Acclaim. Tears of joy followed activation as well. It’s been a real privilege to be able to offer the Acclaim cochlear implant to our patients in this clinical trial. I am delighted that completion of study enrollment brings us a step closer to FDA approval and hopefully being able to offer the Acclaim to all of our properly qualified patients.”

According to DelveInsight’s “Cochlear Implants Market Report, the cochlear implants market was valued at USD 1.38 billion in 2023, growing at a CAGR of 9.92% during the forecast period from 2024 to 2030 to reach USD 2.43 billion by 2030. The cochlear implants market is observing substantial market growth primarily owing to the increasing prevalence of hearing loss & incurs substantial economic costs. Investing in cochlear implants & improving access to these devices and supportive reimbursement policies are anticipated to further accelerate the overall growth of the cochlear implants market during the forecast period from 2024 to 2030.