NeuroLogica Announces FDA 510(k) Clearance for Photon Counting Computed Tomography Using OmniTom Elite 

On March 10, 2022, The state-of-the-art OmniTom Elite acquired 510(k) approval for the addition of Photon Counting Detector (PCD) technology, according to NeuroLogica Corp, a subsidiary of Samsung Electronics Co. Ltd. NeuroLogica introduced the first single-source photon-counting computed tomography (CT) scanner with a single detector that received FDA 510(k) clearance. OmniTom Elite with PCD is capable of producing spectral CT pictures at various energy levels.

Photon counting is a next-generation CT technology that sorts the different energies of X-rays after they have passed through the scan field.  A single X-ray source paired with PCD generates multiple sets of CT data acquired at the same time with configurable energy thresholds without any cross-talk between images.  PCD allows for more accurate imaging and segmentation of bone, blood clots, plaque, hemorrhage, and brain tumors by capturing CT data in various energy bands. With PCD, the dosage requirements might be reduced, and the usage of injected contrast could be substantially altered.

David Webster, Chief Operating Officer of NeuroLogica said, “NeuroLogica is driven by innovation. Since the advent of the world’s first multi-slice mobile CT in 2004, we have always known that point-of-care imaging can improve patient outcomes and increase the likelihood of a better quality of life after a traumatic event. With the introduction of PCD technology to the OmniTom Elite platform, we look to expand the diagnostic possibilities of CT at the patient’s bedside.”

The OmniTom Elite provides adaptable, real-time mobile imaging to provide point-of-care CT to critical patients without requiring them to be transported to a separate imaging department. The mobile device cuts down on the time it takes to diagnose and treat these life-threatening patients.

Rajiv Gupta, Ph.D., MD, Neuroradiology Division Chief of Massachusetts General Hospital and Associate Professor at Harvard Medical School said, “Availability of photon-counting detector technology on a mobile head CT platform is a significant advance in the development of CT. This advance heralds a new era of CT applications in stroke, trauma, ICU and intra-op settings.” 

MGH is collaborating with NeuroLogica and will pilot test the OmniTom Elite with PCD to monitor post-trauma and post-surgical patients.

According to DelveInsight’s “Computed Tomography (CT) Devices Market” report, the global Computed Tomography (CT) Devices Market was valued at USD 5.76 billion in 2020, growing at a CAGR of 6.36% during the forecast period from 2021 to 2026 to reach USD 8.34 billion by 2026. The Computed Tomography (CT) Devices market is witnessing positive growth owing to the rising incidence of severe chronic diseases such as cardiovascular, oncology, and others, further rapid technological developmental activities, growing awareness for early detection, and increasing incidences of the aging population, thereby contributing to the growth of the Computed Tomography (CT) Devices market during the forecast period from 2021-2026.

S.M.A.R.T. RADIANZ™ Vascular Stent System Approved for Transradial Use in the U.S. 

On March 10, 2022, The FDA approved the S.M.A.R.T. RADIANZTM Vascular Stent System, a self-expanding stent specifically designed for radial peripheral treatments, according to Cordis, a worldwide cardiovascular technology company. The S.M.A.R.T. RADIANZTM Vascular Stent System makes stent implantation in the iliac and superficial femoral (SFA) arteries more precise and efficient.

The RADIANZ Radial Peripheral SystemTM, which includes the BRITE TIP RADIANZTM Guiding Sheath and the SABERX RADIANZTM PTA Catheter, is particularly intended to maximize radial access, produce remarkable results, and high levels of patient satisfaction. Radial approaches have a post-procedure complication rate of less than 1%, whereas femoral access has a complication rate of 2% to 4%. Ambulation time is usually reduced from hours to minutes.

The safety and efficacy profile of S.M.A.R.T.® Vascular Stents is validated with a solid foundation of clinical evidence and real-world experience. S.M.A.R.T.® Vascular Stents are the only SE Lower Extremity stents with 10-year follow-up, proven to provide reliable outcomes in over 3,000 patients. S.M.A.R.T.®Vascular Stents have shown comparable one-year revascularization rates and a significantly lower cost of hospitalization versus drug-coated stents. 

Craig M. Walker, MD, President and Founder of the Cardiovascular Institute of the South commented, “I am excited that Cordis has committed to delivering new interventional tools that can be utilized in treating patients with cardiac or vascular disorders via a transradial access. We have been constrained in the greater utilization of this important access site associated with greater patient comfort and less major bleeding as our diagnostic and interventional tools that can be delivered via this access have been limited. These lower-profile devices should expand the utilization of radial access in treating patients.”

Matt Muscari, Cordis President, Americas, said, “At Cordis, we see the RADIANZ Radial Peripheral System™ as a best-in-class option for treating peripheral lesions with the added benefit of reducing the cost of care. Empowered by our legacy, we are now focused on investing in a future of innovation.  We are committed to leading the way in radial access to enable the less-invasive procedures that patients prefer.”

According to DelveInsight’s “Vascular Stents Market” repot, the global Vascular Stents market was valued at USD 12.34 billion in 2020, growing at a CAGR of 7.90% during the forecast period from 2021 to 2026, to reach USD 19.57 billion by 2026. 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 factors responsible for driving the global vascular stents market in the forthcoming years.

OSF Ventures joins early financing for first FDA-cleared wireless seizure detection sensor 

On March 10, 2022, OSF Ventures joined six other investors in a USD 12.5 million Series A funding round for a wireless, wearable EEG (brain wave monitor) that may detect seizures, even if they are non-convulsive and show no symptoms. With participation from Dexcom, Inc. (DXCM), Wavemaker 360, and previous investors MedMountain Ventures and Salt Lake City Angels, Catalyst Health Ventures (CHV), and Genoa Ventures co-led the oversubscribed early financing.

The Epitel wireless sensor is a one-inch square with a unique adhesive that readily attaches to a patient’s head just below the hairline. Two sensors can be worn on the forehead, while the other two can be hidden behind the ear for early detection of cognitive impairment when a physician suspects it. Epitel’s disposable wireless EEG sensors and REMI® remote access software are now FDA approved for use in hospitals, but the business wants to pursue approval for use in a range of patient care settings. 

Epitel’s miniature sensors can be readily attached by bedside nurses instead of EEG technicians in minutes, and brain wave activity may be monitored to detect changes over time. The REMI patient monitoring platform, which is conveniently accessible on a tablet, receives the results from the cloud. The wireless technique eliminates tethered cables, which are included in currently available hard-wired systems, from interfering with the recording of electrographic seizure activity or causing antenna noise. Epitel’s sensors can monitor adult and pediatric patients suspected of having neurological problems in real-time, possibly speeding up diagnosis and treatment at community hospitals.

Dr. Deepak Nair, director of Ambulatory and Virtual Neurology Services for OSF HealthCare Illinois Neurological Institute and a neurological hospitalist at OSF HealthCare Saint Francis Medical Center in Peoria, said “Epitel’s system is truly an innovative solution to a widespread problem – EEG machines and skilled technicians are in short supply, with an ever-growing demand. The Epitel team has developed a simple and powerful tool that allows us to provide remote EEG monitoring, increasing the speed of diagnosis and treatment. This approach to diagnostic medicine is exactly the transformative thinking that will help decentralize the delivery of advanced neurological care.”

OSF Ventures will be collaborating with Epitel to further support its value proposition as the company works to commercialize its REMI platform. 

Epitel Chief Executive Officer Mark Lehmkuhle, Ph.D., commented, “We look forward to additional clinical input from the specialists at OSF HealthCare and we are honored to have the support of OSF Ventures as part of a strong investment syndicate that will help us advance our platform and our product pipeline. We’re motivated by our belief that quick diagnosis and treatment enabled by our technology can lead to more effective treatment plans, better outcomes, and improved quality of life for those with epilepsy and other neurological disorders.”

According to DelveInsight’s “Brain Monitoring Devices Market” report, the global Brain Monitoring Devices Market was valued at USD 5.89 billion in 2020, growing at a CAGR of 7.27% during the forecast period from 2021 to 2026, to reach USD 9.13 billion by 2026. 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.

NovaSight reports positive data from amblyopia treatment device 

On March 11, 2022, NovaSight announced positive results from a pivotal study of CureSight, their eye-tracking-based digital therapy device for the treatment of amblyopia, or ‘lazy eye.’ While watching any streaming video using red-blue therapy glasses, the digital equipment is meant to teach the visual system to use both eyes equally. CureSight employs real-time image processing and algorithms to blur the picture’s center of vision presented to the strong eye, encouraging the amblyopic eye to function as a team with the stronger eye.

It can be used at home, and it uses a Cloud gateway to communicate treatment reports with caregivers. The randomized, multicentre, controlled pivotal clinical trial was conducted on 103 subjects aged four to nine years in six medical centers, including Sheba Medical Center in Tel Aviv, Israel.  Participants in the trial were randomly assigned, and the improvement in visual outcomes attained with CureSight digital therapy was compared to eye patching, the current gold-standard-of-care treatment for amblyopia.

The study’s top-line analyses showed that the improvement of Best Corrected Visual Acuity (BCVA) at week 16 was high in the CureSight digital treatment group versus the eye patching group.

NovaSight stated that the pivotal trial also assessed adherence and patient satisfaction. 

NovaSight CEO Ran Yam said, “Eye patching is effective when patients are compliant, however, patching is often associated with insufficient adherence due to the discomfort it brings to the patient and the social stigma that many children experience when wearing a patch.”

The company said that the completion of the CureSight pivotal trial represents a significant step towards securing approval from the FDA, following the device’s receipt of CE mark.

Rockley Photonics and Medtronic Collaborate to Deliver the Next Generation of Wearable Healthcare Monitoring Devices 

On March 10, 2022, Rockley Photonics Holdings Limited, a global pioneer in photonics-based health monitoring and communications solutions, established a development agreement with Medtronic, a global healthcare technology company. Rockley’s newly announced BioptxTM biomarker sensing platform will be integrated into Medtronic’s products for usage in a variety of healthcare settings.

The Bioptx platform provides an end-to-end sensing solution that combines cloud analytics and artificial intelligence (AI) to provide a comprehensive evaluation of a variety of conditions.

The collaboration with Medtronic contributes to the societal move from reactive to proactive healthcare by possibly providing round-the-clock, real-time, non-invasive monitoring of a person’s health and well-being, allowing physicians to personalize care based on actionable data.

Dr. Andrew Rickman, chairman, and chief executive officer of Rockley, said, “This partnership combines Medtronic’s exceptional strength in providing in-patient care with Rockley’s expertise in wearable, remote monitoring. I believe that this collaboration will bring to life our vision of giving people better insights into their health and well-being. We are excited about the potential for this partnership to herald the next generation of wearable devices and deliver a complete lifecycle of patient care.”

According to DelveInsight’s “Vital Sign Monitors/External Remote Patient Monitoring Devices Market” report, the global vital sign monitors market was valued at USD 7.59 billion in 2020, growing at a CAGR of 7.94% during the forecast period from 2021 to 2026, to reach USD 11.97 billion by 2026. The rise in demand for vital sign monitors is primarily attributed to the growing burden of the old age population across the globe, the increase in the prevalence of a variety of lifestyle-associated disorders such as respiratory disorders, cardiology disorders, among others. Moreover, constant efforts of the key manufacturers for developing technologically advanced vital sign monitoring devices, and the rise in approval of the products portfolio, among others are the factors responsible for the growth of vital sign monitoring devices.

Cardiawave Announces the Success of Its Clinical Trial to Treat Aortic Stenosis Using VALVOSOFT®, Its Disruptive, Non-Invasive, Ultrasound Treatment

On March 14, 2022, Cardiawave SA, a deeptech medical device company that invented VALVOSOFT®, a novel non-invasive medical device to treat aortic stenosis, the most common heart valve condition in adults, has announced the completion of its safety and feasibility clinical study.

VALVOSOFT® is a ground-breaking technique that enables the remote deployment of a highly accurate and concentrated therapeutic ultrasound beam to help patients with aortic stenosis regain valve function. The aortic valve stiffness is reduced and its functional opening is improved, allowing adequate oxygenated blood to reach the brain and the rest of the body. Because the only existing medical treatment for aortic stenosis is to replace the aortic valve with open-heart surgery or a minimally invasive percutaneous valve (TAVI) for the most seriously afflicted individuals, this non-invasive therapy represents a novel therapeutic option.

The FIH 1 study

The purpose of the FIH I study was to assess the safety and operating system of the first generation of VALVOSOFT® as well as the clinical effects of softening calcific aortic valve tissues with a beating heart.

30 patients (average age 84yrs, with 9 patients over 90) have been successfully treated in France and the Netherlands with the last being in Q4 2021. VALVOSOFT® provided a sustained repair to the aortic valve for up to 12 months post-treatment. The study has proven the safety and efficacy, as well as the ease of the procedure with 60-minute non-invasive outpatient treatment. Following the successful VALVOSOFT® treatment, two patients were able to have TAVI valve replacement.

Benjamin Bertrand, CEO of Cardiawave, said, “The positive results of the safety and feasibility clinical studies we observed in our First In Human trial are extremely encouraging. We have shown that VALVOSOFT® can treat patients who are exceedingly fragile and sick for whom no medical solution exists today. This represents a new treatment solution for aortic stenosis, over and above aortic valve replacement from which only a small minority of patients can benefit. Cardiawave’s VALVOSOFT® has the potential to become a standard new treatment for this deadly disease. We are currently working on receiving the necessary authorizations in Europe for further clinical trials over the next few months. I am confident that these will once again confirm the therapeutic benefits of VALVOSOFT®.” 

Professeur Emmanuel Messas the Georges Pompidou European Hospital (AP-HP), in Paris, declared, “VALVOSOFT®’s non-invasive treatment brings great hope for patients with aortic stenosis and their families. It offers the possibility of efficient outpatient treatment for fragile patients, for whom valve replacement is too risky. In the longer term, treating patients with less severe stenosis would be a major step forward.” 

The second feasibility and safety FIH II study are underway with 10 further patients in Serbia. This includes brain MRI evaluation both before and after treatment to assess the risk of a stroke. Four patients were safely treated by the end of December 2021. None of the MRIs detected an abnormality. Six further patients will be treated during H1 2022.

Next steps

On the back of these promising clinical results, Cardiawave has launched its Series B financing. This is expected to be completed in the second half of 2022. These funds will be used to finance the next phase of clinical trials in Europe and the United States.

Between April and December 2022, Cardiawave plans to enroll around 50 aortic stenosis patients across 10 hospitals in France, the Netherlands, and Germany. This new European clinical trial targets the granting of a CE mark. The clinical trial protocol includes patient monitoring after 1, 6, and 12 months.

According to DelveInsight’s “Aortic Stenosis Market” report, Aortic stenosis is one of the most common and serious valve disease problems. Although some people have aortic stenosis because of a congenital heart defect called a bicuspid aortic valve, this condition more commonly develops during aging as calcium or scarring damages the valve and restricts the amount of blood flowing through, as per the American Heart Association, Inc. 2022.