Baird Medical Received the US FDA Clearance for a Microwave Ablation System

On November 22, 2023, Baird Medical announced the US Food and Drug Administration clearance of the company’s microwave ablation (MWA) system and disposable needles for use in the US.

The clearance allows the use of the technology to ablate thyroid nodules, breast tumors, and other diseases where soft tissue needs to be removed by US doctors. The patients in the US will have access to another less invasive method to remove thyroid nodules – lumps in the thyroid that are estimated to be in around 40% of the population.

Radiofrequency ablation has become a popular treatment option for benign thyroid nodules. The nodules are heated and destroyed with an electric current during the non-invasive process. MWA may have various advantages over normal radiofrequency ablation, including increased thermal efficiency, however, this comes at the expense of vulnerability to surrounding tissues. According to Baird Medical, this technology accurately targets the nodule with a hot needle while sparing surrounding tissue. 

Baird Medical mentioned occupying 35% market share of microwave ablation devices in China. In July 2023, the system was approved by China’s National Medical Products Administration (NMPA) to treat benign thyroid nodules. 

In the US market, Baird Medical has estimated the opportunity for microwave ablation systems of around USD 1.6 billion.

 Baird Medical founder and CEO Haimei Wu said, “This clearance grants us the ability to market our portfolio of MWA systems and disposable needles in the United States.” 

As per DelveInsight’s Ablation Devices Market” report, the global ablation devices market is estimated to grow at a CAGR of 11.65% during the forecast period from 2023 to 2028. Factors such as the increasing incidence of cancers such as liver cancer, the rising prevalence of chronic pains such as musculoskeletal pains, the rising prevalence of cardiac arrhythmias such as atrial fibrillation, and the rising regulatory approvals for technologically advanced ablation devices are driving the market of ablation devices during the forecast period. Therefore, the market for ablation devices is estimated to grow at a significant CAGR during the forecast period from 2023 to 2028.

Revvity Launched EONIS Q System Enabling Faster, Simplified Newborn Screening for SMA and SCID

On November 27, 2023, Revvity, Inc., announced the launch of its EONIS™ Q system, a CE-IVD declared platform enabling laboratories in countries that accept the CE marking to adopt molecular testing for spinal muscular atrophy (SMA) and severe combined immunodeficiency (SCID) in new-borns.

The EONIS Q system, which includes the EONIS Q96 instrument, the EONIS SCID-SMA kit, and specialized EONIS EASI software, simplifies and expedites molecular testing for SMA and SCID through an inventive workflow. The EONIS Q workflow has a turnaround time of about three hours from sample-in to result, and its software capability is superior to that of traditional wet qPCR solutions. Further cutting down on hands-on time are the elimination of wash steps and the reduction of pipetting and centrifuging steps. For labs considering implementing the system, the EONIS Q system further optimizes resource and cost efficiencies by utilizing fewer consumables and single-use plastic ware than other approaches.

By 2025, all newborns in Europe will be required to undergo screening for spinal muscular atrophy (SMA) by the European Alliance for Newborn Screening in SMA, an advocacy group founded by SMA Europe. The EONIS Q system’s CE-IVD declaration and related solutions make strides toward accomplishing this objective. 

“Helping children get a healthier start to life is at the heart of our work and making molecular testing for inherited conditions like SMA and SCID more accessible can help further that aim,” said Petra Furu, general manager of reproductive health at Revvity. Petra added, “Without compromising quality, speed, or test result accuracy, the EONIS Q system is designed to break down some of the common barriers that prevent newborn screening labs from adopting these tests.”

According to DelveInsight’s “Molecular Diagnostics Market” report, the global molecular diagnostics market was valued at USD 16.94 billion in 2021, growing at a CAGR of 9.16% during the forecast period from 2023 to 2028, to reach USD 28.44 billion by 2028. The increase in demand for molecular diagnostics is primarily attributed to the growing incidence of infectious diseases such as the sudden outbreak of COVID-19 and the rising burden of cancers across the globe. Moreover, rapid technological advancement in the molecular diagnostic product arena and increasing demand for point-of-care diagnostics along with rising consumer awareness regarding quick diagnostics, among others, are some of the key factors responsible for the molecular diagnostic market growth during the forecasted period.

FormaPath Announced Advancement in Cancer Pathology with the Launch of AdiPress

On November 28, 2023, FormaPath announced the commercial launch of AdiPress, the first and only automated tool to standardize lymph node dissection. 

The recovery of lymph nodes within fatty cancer tissue can now be automated by cancer-focused pathology practices, ensuring more accurate staging of cancer patients and guiding their follow-up therapy aimed at preventing cancer recurrence. Using a traditional method that involves sampling a subset of lymph nodes within a tissue specimen with a scalpel and then relying on this subset to represent all the nodes that were surgically removed, pathology labs have been using manual dissection of lymph nodes for cancer staging for decades. To make a staging decision for colon cancer, for instance, a pathologist must examine a minimum of 12 nodes according to guidelines set forth by the medical society. Since most colon cancer tissue specimens contain more than 12 nodes, there is always a chance that positive nodes will be overlooked during the sampling process. This could lead to “under-staging,” where the patient receives insufficient adjuvant therapy if their chances of a favorable long-term outcome are reduced.

“The use of an automated method to identify lymph nodes has the potential to impact colorectal cancer staging after surgery,” said Dr. Michael Dugan, MD, Chief Medical Officer, FormaPath.

By automating the process of separating lymph nodes from fatty cancer tissue, AdiPress lowers this risk. AdiPress’s patented Automated Compressive Filtration (ACF) method isolates every lymph node present in pericolic fat, producing concentrated lymphatic tissue. After that, the tissue is prepared for routine microscopic examination by being placed in square wells within specialized tissue containers known as LymFilters. Medical oncologists, pathology assistants, MD pathologists, and patients can all feel more secure about the accuracy of pathology reports—which will ultimately dictate their course of treatment—when they use AdiPress. Significantly, a lack of qualified workers is another issue that many pathology labs nowadays are dealing with. 

Compared to laborious, manual dissection, which can take up to 45 minutes, automating this nodal dissection step reduces the time needed to isolate pertinent lymph nodes to about two minutes. The ACF process standardizes lymph node dissection, ensuring reproducibility and minimizing variation caused by manual dissection performed by various personnel. For laboratories, this can have a big payoff because the time saved can be used to move skilled labor to other tasks. When extraneous fat is removed from lymph nodes using ACF, pathologists can more easily review microscopic slides.

Alex Bodell, Chief Technology Officer, FormaPath said, “The launch of AdiPress is a key turning point for the automated lab of the future. AdiPress, which improves workflow and creates process standardization, will be the future backbone of all labs processing cancer specimens. I look forward to working with labs to demonstrate the immediate value that AdiPress can bring to their operations.”

FormaPath is actively promoting AdiPress to laboratories in the United States, with an emphasis on facilities in cancer centers with high caseloads and hospital networks with many labs under administration. Any laboratory interested in a product demonstration can do so through the FormaPath website.

“Once again I am fortunate to help oncology practice improve as another legacy method for diagnostic classification is upgraded with a new standardized system. Having been involved in precision medicine for over 20 years, it is gratifying to bring this major advance into clinical practice. Unlike other disruptive technologies I have launched, AdiPress serves the interests of all relevant stakeholders. Nobody who currently works with lymph node dissection will miss the passing of the antiquated and labor-intensive procedure for manual dissection. We believe that once the impact of AdiPress is understood in the wider market, the concept of ‘Census-level’ dissection will become the new standard for tumor staging, and any approach that relies on mere sampling will be left behind as inadequate. Patients deserve no less,” said Ted Snelgrove, Chief Executive Officer, of FormaPath.

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, the growing manufacturers’ focus on developing 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.

AWAK Technologies Announced FDA Breakthrough Device Designation for their Artificial Intelligence-Enabled Kidney Disease Prediction Tool

On November 27, 2023, AWAK Technologies (AWAK), a pioneering medical technology company developing a wearable dialysis product and other complementary solutions for chronic kidney disease (CKD) management, announced that the US FDA has designated its kidney disease progression prediction (KDPP) Artificial Intelligence (AI) model for CKD patient care as a breakthrough device. 

The KDPP model aids in determining the risk of kidney disease development and the need for renal replacement therapy (dialysis or transplant) after one, two, and five years.

AWAK and Ever Fortune have collaborated. AI (EFAI), a Taiwan-based spin-off business of China Medical University Hospital (CMUH), was responsible for the development of this ground-breaking AI technology. The two companies entered into a strategic partnership in September 2021 to revolutionize the diagnosis, treatment, and management of kidney disease by building solutions using medical big data and artificial intelligence.

Suresha Venkataraya, Chief Executive Officer of AWAK Technologies said, “This designation is a key milestone which will enable us to accelerate product validation and we look forward to working with the agency to help bring this predictive AI model into clinical practice. We are delighted to work with our partners in this journey, who share our passion for bringing transformative solutions for timely detection and treatment of kidney disease to reduce the physical, mental, and financial burden on the patients and the healthcare system.”

Dr. Chin-Chi Kuo of CMUH, a Medical Consultant of EFAI said, “AI is revolutionizing healthcare with machine learning-based data intelligence, providing unparalleled insights. The innovative AI models developed using the CMUH iHi (ignite Hyper-intelligence) platform exemplify this transformation. These models offer clinicians advanced tools for CKD management, enabling effective risk stratification and optimal resource allocation. This innovation heralds a new era of proactive, intelligent kidney care, showcasing a significant leap in healthcare technology and digital patient management strategies.”

AWAK has also entered into a research collaboration with Singapore General Hospital (SGH) to jointly work on developing new AI models as well as testing the existing KDPP model using the hospital’s de-identified CKD patient database to address unmet needs in managing kidney disease in other regions.

AWAK is now in advanced conversations with partners in the United States about adapting and integrating its revolutionary products into the US market. Mandar Gori, AWAK’s Chief Business Officer, is coming to California, United States, to develop a strong ground presence and expedite relationships in the region. In time, the US team will grow to include clinical, regulatory, and other expertise, reaffirming AWAK’s commitment to kidney disease patients and their caregivers, globally.

Abel Ang, Chairman of AWAK Technologies said, “We are thrilled to have received a second Breakthrough Device Designation from the US FDA, making us one of the few Asia-based MedTech companies with multiple FDA breakthrough device designations. With our recent US$20+M series B fundraise, we are excited about expanding our activities into the United States, the largest dialysis market in the world.”

According to DelveInsight, the global Chronic Kidney Disease market is estimated to grow at a CAGR of 6.6% during the forecast period from 2023 to 2028. Factors such as the increasing incidences of chronic kidney disease, technological advancements in diagnostic tests for kidney diseases, and the increasing need for early detection are promoting market growth during the forecast period from 2023 to 2028.

Pramand Launched CraniSeal™ Dural Sealant to Give Surgeons a New Option for Dural Repair

On November 28, 2023, Pramand LLC announced the US commercial launch of the CraniSeal™ Dural Sealant System. CraniSeal is indicated for use in patients ≥ 18 years of age as an adjunct to sutured dural repair during cranial surgery to provide watertight closure.

CraniSeal Dural Sealant is an absorbable polyethylene glycol (PEG) hydrogel that is put over sutures with an applicator. This sealant keeps cerebrospinal fluid from leaking out of an incision site during cranial surgery. The underlying technology has been employed in a range of medical applications for over two decades. 

Amar Sawhney, Ph.D., Pramand’s CEO, remarked, “We are excited to offer neurosurgeons and hospitals a choice for cranial dural sealing with CraniSeal which uses proven, highly effective technology with a long record of safety and efficacy.” Dr. Sawhney previously invented DuraSeal® Dural Sealant, which has become the market-leading dural sealant globally.”

CraniSeal, a Class 3 product that required Pre-Market Approval (PMA), was approved by the Pramand team in just 3.5 years. The PMA procedure typically takes 7 years to approve a basic Class 3 device. 

According to DelveInsight’s “Surgical Sealant and Adhesives Market” report, the global surgical sealant and adhesives market was valued at USD 2.18 billion in 2022, growing at a CAGR of 7.58% during the forecast period from 2023 to 2028 to reach USD 3.39 billion by 2028. The surgical sealant and adhesives market is slated to witness prosperity owing to the growing prevalence of chronic health problems such as cardiovascular problems, kidney problems, neurological issues, and others. The rise in road accidents requiring urgent surgeries is another factor in the growth of the surgical sealant and adhesives market. The continuous rise in cosmetic surgeries and growing focus on improving the safety, affordability, and usability of surgical sealants and adhesives are further expected to result in appreciable revenue growth in the surgical sealant and adhesives market during the forecast period (2023-2028).

BrainSpec Received Full FDA Clearance to Begin Using AI-Backed Solution for Non-Invasive Brain Chemistry Measurement

On November 27, 2023, BrainSpec, the comprehensive software platform enabling virtual biopsies of the brain, was awarded clearance by the US FDA to begin using their Magnetic Resonance Spectroscopy (MRS) platform to provide a non-invasive measurement of brain chemistry to support the diagnostic process in the most common brain-related illnesses, including Alzheimer’s disease, multiple sclerosis, epilepsy, brain tumors, and more. 

This marks the first time software using a reference database of brain chemistry has been included in an FDA clearance.

BrainSpec CoreTM monitors chemical concentrations in the brain using non-invasive imaging to construct a virtual biopsy utilizing ordinary MRI scanners. Unlike MRI, which offers anatomical images, MRS examines the chemical makeup of tissues, allowing for more exact diagnosis and treatment. 

MRS detects metabolites present at far lower quantities than normal MRI, which produces images of the brain by visualizing fat and water distributions. BrainSpec employs cutting-edge signal processing techniques to monitor relative metabolite levels across the brain and over time, resulting in rich multidimensional data that can be fed into sophisticated AI models. The software is compatible with GE, Siemens, and Philips 3T MRI scanners and is available to any medical facility via cloud-based platforms.

Adding MRS to the diagnostic process has been proven to save up to USD 98 thousand per patient in healthcare costs over a 5-year time horizon when compared to the present standard of care alone.

“We are thrilled to be given this full clearance by the FDA. It signals a new era of software enhancements that will not only complement but also speed up the complicated and lengthy process of diagnosis. Our aim is not to replace the critical role of physicians but to augment their expertise with invaluable information previously unavailable. We believe that by equipping healthcare professionals with cutting-edge tools, we can empower them to make more informed and precise treatment decisions, ultimately leading to improved patient care,” said Alex Zimmerman, CEO and co-founder, of BrainSpec.

“There are several key advantages of this AI solution that have important clinical relevance,” said Raymond Y. Huang, MD, PhD, Division Chief, Neuroradiology, Brigham and Women’s Hospital. Raymond added, “First, it provides quantitative neurometabolite measurements that can be used to aid in monitoring the changes in brain tumors that are undergoing therapy. The second strength is that it automates the delivery of the MR spectroscopy results, reducing turn-around time from days to minutes which is critical for the clinical care of patients. Finally, the ability to measure 2-hydroxyglutarate and other brain metabolites provides a direct and non-invasive marker of low-grade gliomas that could lead to a more accurate classification of individual tumors benefitting decision making.”

“The ability to measure relative 2-hydroxyglutarate levels leads to a more accurate classification of individual tumors benefitting treatment decision making which is in the best interest of patients,” said David A. Reardon, M.D., Clinical Director, Center for Neuro-Oncology, Dana-Farber Cancer Institute. David added, “There has been a high unmet medical need for reliable and quantitative neuroimaging methods for the management of brain tumor patients.”

“It’s similar to when television went from black and white to full color. We can see so much more in greater detail with the transition. Our hope is that this will make spectroscopy much more available to the public,” mentioned David A. Reardon, M.D.According to DelveInsight’s “Brain Monitoring Devices Market” report, the global brain monitoring devices market was valued at USD 6.31 billion in 2022, growing at a CAGR of 7.27% during the forecast period from 2023 to 2028, to reach USD 9.61 billion by 2028. The demand for brain monitoring devices is primarily being boosted by the rising prevalence of neurological diseases, technological advancement in product development, rising awareness about neurodegenerative diseases, and increasing applications of brain monitoring in clinical trials. The growing demand for minimally invasive devices and the expanded therapeutic applications of brain monitoring devices are further expected to boost the brain monitoring devices market growth.