TE Air Handheld Ultrasound System Launched by Mindray 

On March 16, 2023, Mindray, a China-based company announced the launch of TE Air, a high-quality, wireless, handheld, portable ultrasound device that is designed to easily fit into a pocket.

Built with Mindray’s eWave platform and second-generation Single Crystal technology, TE Air generates high-quality images with low power consumption. The presence of dedicated exam presets, and comprehensive imaging modes assist clinicians to perform ultrasounds more efficiently and allows them to make more accurate clinical decisions. 

TE Air also features high-level disinfection tolerance, a waterproof and dustproof design as well, and flexible charging to extreme mobility. The system’s Air Capsule doubles as a protective case and portable wireless charger. The device gets charged in just 35 minutes. 

TE Air app is available for both Android and iOS to allow for one-handed operation in any location. It can also connect with devices like the Mindray TEX20 ultrasound system and integrate with hospital information systems.

Xujin He, GM of Mindray’s medical imaging systems business unit commented, “Built from Mindray’s leading technologies, the TE Air has made a historic breakthrough in the image quality level of handheld ultrasound, integrating professional-level image quality into a small and light wireless system.” Xujin added, “Its premium performance and wireless portability allow clinicians to diagnose anytime and anywhere with confidence.”

As per DelveInsight’s Ultrasound Devices Marketreport, the global ultrasound devices market was valued at USD 6.76 billion in 2021, growing at a CAGR of 6.82% during the forecast period from 2022 to 2027 to reach USD 10.05 billion by 2027. The ultrasound devices market is witnessing positive growth owing to the rising incidence of severe chronic diseases such as cardiovascular, urology, and others, further rapid technological developmental activities, growing awareness for early detection, and increasing geriatric population across the globe who are more susceptible to developing chronic disorders, and rising adoption owing to no radiation exposure, thereby contributing to the growth of the ultrasound devices market during the forecast period.

Getinge Received US FDA Premarket Approval for the iCast™ Covered Stent System

On March 24, 2023, Getinge, announced that it has received premarket approval from the US Food and Drug Administration for its iCast™, which is meant for the treatment of patients with iliac arterial occlusive disease, a type of peripheral artery disease. 

The iCast covered stent system is the most clinically evaluated balloon expandable polytetrafluoroethylene (ePTFE)-covered stent worldwide and has been used by clinicians for almost 20 years. 

iCast™ is being sold under the brand name Advanta V12 covered stent in markets outside the US. 

“We are pleased that the iCast™ stent system is approved in the United States for use in iliac arteries to benefit an even greater number of patients,” commented Elin Frostehav, President of Acute Care Therapies at Getinge. Elin added, “The global market for covered stents is growing at an annual rate of 5%. Getinge will continue to ramp up capacity throughout the year in order to meet the demand.”

According to DelveInsight’s Peripheral Artery Disease Marketreport, the peripheral artery disease market was valued at USD 3,757.64 million in 2021, growing at a CAGR of 6.64% during the forecast period from 2022 to 2027 to reach USD 5,469.02 million by 2027. The peripheral artery disease (PAD) market is observing remarkable market growth due to the factors such as the escalating burden of the geriatric population and the rising prevalence of peripheral artery disease (PAD) and arteriosclerosis across the globe. Further, the rising prevalence of obesity, diabetes, and high blood pressure, increasing product launches and approvals, and others will create a necessity for peripheral artery disease (PAD) in the market. Therefore, the market for peripheral artery disease (PAD) is estimated to grow at a substantial CAGR during the forecast period from 2022 to 2027.

First Patient Treated in a Clinical Trial of FLASH Proton Therapy for Cancers in the Bones of the Chest

On March 28, 2023, the first participant was given treatment in a clinical trial of FLASH proton therapy, an investigational mode of radiation therapy delivery for cancers in the bones of the chest at the Cincinnati Children’s/University of Cincinnati Medical Center Proton Therapy Center, with the sponsorship of Siemens Healthineers. FLASH therapy can be administered to a patient in less than 1 second with fewer side effects than standard forms of radiation delivery. 

The Proton Therapy Institute in Cincinnati, which continues to be a leader in international research on FLASH proton therapy, has accomplished much with the current study, known as FAST-02.

The FAST-01 study (FeAsibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases), the first clinical trial using FLASH proton therapy in humans, represented a major advance. The participants in that study had bone metastases in their extremities.

Researchers from Cincinnati Children’s and the University of Cincinnati are currently working together to determine the effectiveness of ultra-high dose rate proton therapy in the treatment of uncomfortable bone metastases in the chest. 

The FAST-02 study is funded by Varian, a division of Siemens Healthineers. The clinical trial for FLASH proton therapy is going to enroll ten adults whose metastatic cancer has spread to their chest bones. 

FLASH proton therapy has shown the potential to reduce the side effects of radiation treatment compared to conventional radiation in pre-clinical trials. However, until recently, the technology to deliver FLASH radiation to cancer patients was not available.

“Our dedicated team of researchers, clinicians, and staff are committed to advancing the field of cancer treatment and finding new ways to improve patient outcomes,” said John Breneman, MD, medical director of the Cincinnati Children’s/UC Medical Center Proton Therapy Center, who is the principal site investigator for the FAST-02 clinical trial.

John Perentesis, MD, who is the research director of the Proton Therapy Center and director of oncology and cancer programs at Cincinnati Children’s, commented, “This trial of an ultra-high dose rate of proton therapy is just one of our efforts to develop new and innovative cancer treatments.” John said, “Our goal is to establish a foundation for future potential trials in brain tumors, sarcomas, lymphomas, lung cancer, and other malignancies, and we are excited about the impact this research might have on cancer care.”

According to DelveInsight’s Cancer Therapy Market report, the global cancer therapy market was valued at USD 169.39 billion in 2021, growing at a CAGR of 9.12% during the forecast period from 2022 to 2027, to reach USD 285.96 billion by 2027. The cancer therapy market is witnessing positive market growth owing to the rising prevalence of various cancers.

Further, the presence of factors like an increasingly aging population wherein age plays a key role in cancer development in certain cancer types, namely breast cancer, will also propel the market of cancer therapy. Moreover, the growing focus on developing targeted therapies due to advancements in precision medicine to provide a more pronounced therapeutic effect further drives the cancer therapy market as new products are gaining regulatory approvals for cancer treatment.

Gore Announced The Gore® Viafort Vascular Stent IVC Study’s did First US Enrollment

On March 28, 2023, W. L. Gore & Associates (Gore) announced that the first patient from the United States has been enrolled in a prospective, non-randomized, multi-centered, single-arm study with a 5-year follow-up to assess the investigational GORE® VIAFORT Vascular Stent for the treatment of Symptomatic Inferior Vena Cava (IVC) obstruction with or without combined Iliofemoral Obstruction.

The GORE VIAFORT Vascular Stent uses the Gore expanded polytetrafluoroethylene (ePTFE) technology in conjunction with a single wire, sinusoidal-wound nitinol frame and has been given the FDA’s Breakthrough Device designation. The Gore VIAFORT Vascular Stent IVC study is testing the product in a treatment range for iliofemoral veins and the IVC with a diameter of 10-28 mm. The study is being carried out in the United States under a valid investigational device exemption (IDE).

Kush Desai, M.D. at Northwestern University Feinberg School of Medicine in Chicago, Illinois, enrolled the clinical trial’s first patient. Dr. Desai said, “It is exciting to have enrolled the first U.S. patient, an important milestone for treating venous occlusive disease. With no device options indicated, or frankly designed for both IVC and iliofemoral venous disease, implanting the GORE VIAFORT Vascular Stent in patients represents a significant step forward in research and ultimately management of these complex patients.”

As per DelveInsight’s “Vascular Stents Market” report, the global vascular stents market was valued at USD 13.31 billion in 2021, growing at a CAGR of 7.90% during the forecast period from 2022 to 2027, to reach USD 21.01 billion by 2027. The increase in demand for vascular stents is predominantly attributed to the growing prevalence of vascular disorders such as atherosclerosis, carotid artery diseases, and peripheral artery diseases, among others. In addition, growing preferences for minimally invasive surgeries among the patient population, growing technological advancement in the product arena, and approval of various vascular stents, among others, are some of the key factors responsible for driving the global vascular stents market in the forthcoming years.

CoreLink Received FDA Approval for the Siber® Ti-3D Printed SI Joint Fusion System

On March 29, 2023, CoreLink, LLC, a leading designer and manufacturer of innovative spinal implant systems announced the 510(k) clearance from the US Food and Drug Administration (FDA) for its Siber® Ti Sacroiliac Joint Fusion System. The Siber Ti System provides a broad range of fully porous, nanosurfaced, 3D-printed implants. 

CoreLink’s patented Mimetic Metal® technology is used in these new implants to mimic natural bone with directional lattice architecture and trabecular pores, as well as features at the macro, micro, and nano (MNM) levels. 

In-vitro studies found Mimetic Metal to have higher osteoblastic activity than machined solid titanium, PEEK, and HA-PEEK, while in-vivo studies found bony in-growth and on-growth in cortical and cancellous bone.

With a variety of diameter and length options, the system allows surgeons to precisely fit patient anatomy and maximize points of fixation. Dual-lead threads with varying pitches are designed to provide true joint compression and a strong purchase. When combined with self-harvesting threads, this creates an ideal environment for successful fusions.

Dr. Kris Radcliff said, “With the SI fusion market rapidly expanding, it’s important to choose implants best suited for my patients from companies with a history of success in the space. CoreLink Surgical has proven their success in this space with a strong SI portfolio for over 7 years. With their latest innovation—Siber Ti—I’ll have a completely comprehensive system that will allow me to choose what’s best for each patient’s unique surgical need.”

“At CoreLink our mission is to deliver life changing options for patients, while offering innovative and efficient solutions to physicians and our entire healthcare system. The Siber Ti System accomplishes just that. Siber Ti will provide surgeons versatility for use in posterior, oblique, and lateral implantation approaches, while compression and non-compression implants allow for use in trauma and non-trauma related cases. It’s a very versatile and comprehensive system.” said Jay Bartling, CEO of CoreLink.

According to DelveInsight’s Spinal Implants Market” report, the global spinal implants market is estimated to be 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 disc herniation, spinal stenosis, and degenerative disc diseases, among others, in the older population across the globe. Moreover, shifting focus toward technological advancement in bone graft products, rising awareness among the patient population regarding the spinal disorder and their proper management, and rising preferences for minimally invasive surgeries are the factors driving the spinal implants market.

USound and Partners Collaborated to Bring Next-Generation Over-the-Counter Hearing Aids

On March 29, 2023, USound, a leading provider of advanced audio solutions, announced its collaboration with partners to develop and deliver a reference design for a cutting-edge over-the-counter (OTC) hearing aid. The reference design will incorporate USound’s newest Kore 4.0 audio module, ASE’s Micro SiP (System-in-Package), and OBO Pro2’s innovative hearing aid design, resulting in the market’s most advanced hearing aid.

The collaboration brings together the strengths of all three companies. The expertise of USound in advanced audio technology, as well as its newest Kore 4.0 module, will ensure superior sound quality and performance. The most compact Bluetooth Micro SiP, designed specifically for hearable devices, is provided by ASE Chung-Li; OBO Pro2, an experienced hearing aid manufacturer, delivers the OTC hearing aid and integrates all components into a sleek and user-friendly device. 

The reference design enables hearing aid manufacturers to quickly develop and manufacture OTC hearing aids that meet the highest performance and reliability standards. With an estimated 500 million people worldwide suffering from hearing loss, the market for over-the-counter hearing aids is expected to expand significantly in the coming years.

“We are thrilled to partner with OBO Pro2 and ASE Chung-Li to create a state-of-the-art over-the-counter hearing aid that meets the needs of millions of people suffering from hearing loss worldwide. Our Kore 4.0 module combined with ASE’s latest Bluetooth Micro SiP provides a superior audio experience, while OBO Pro2’s expertise in hearing aid design ensures that the device is easy to use and comfortable to wear,”

Ferruccio Bottoni, CEO of USound

“Collaborating with Usound that embedded ASE’s Micro SiP to provide a high-quality and reliable hearing aid solution to our customers. We believe that our expertise in hearing aid design combined with USound’s advanced audio technology will enable us to deliver a superior product that will make a positive impact on people’s lives.” said the CEO of OBO Pro2.According to DelveInsight’s Hearing Aid Devices Market” report, the global hearing aid devices market was valued at USD 7.01 billion in 2021, growing at a CAGR of 5.47% during the forecast period from 2022 to 2027, to reach USD 9.61 billion by 2027. The rise in demand for hearing aid devices is predominantly attributed to the growing prevalence of hearing loss globally, coupled with the rising geriatric population. Moreover, an increase in exposure to high-frequency sounds leading to noise-induced hearing loss could also augment the hearing aids market. In addition, technological advancement and raising awareness, and government initiatives about hearing aid devices are likely to propel the global hearing aid devices market.