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Eclipse Launches MicroPen EVO™ Advanced Micro-needling Device
On June 01, 2021, Eclipse, a leading aesthetic and medical manufacturer, received FDA clearance of their latest medical-grade micro-needling device, the MicroPen EVO. It had launched MicroPen EVO in Canada last year and now will make it available to dermatology and aesthetic practices in the United States.
Tom O’Brien, CEO, and Founder of Eclipse said, “We are very excited to announce the FDA clearance of the MicroPen EVO. This represents the start of multigenerational product offerings that will propel Eclipse for many years to come.”
Eclipse first entered the micro-needling device industry with the MicroPen, widely regarded as the premier pen at its launch. In 2015, the MicroPen Elite was launched, introducing both form factor and technological improvements. Together, the two MicroPen products made Eclipse the industry leader in micro-needling devices.
Aethlon Medical Publishes Case Studies of Two Critically Ill COVID-19 Patients Treated with the Hemopurifier®
On June 03, 2021, Aethlon Medical, Inc. announced the publication of a pre-print manuscript highlighting two case studies of critically ill COVID-19 patients treated with the Aethlon Hemopurifier®, titled “Removal of COVID-19 Spike Protein, Whole Virus, Exosomes and Exosomal microRNAs by the Hemopurifier® Lectin-Affinity Cartridge in Critically Ill Patients with COVID-19 Infection” and was published in Research Square. The patients were given access to Hemopurifier® treatment through Emergency Use.
The cartridge is made to filter viruses and exosomes from the blood and was used for nine sessions in two critically ill COVID-19 patients. The first patient showed improvement in COVID-19 associated coagulopathy (CAC), lung injury, inflammation, and tissue injury despite the absence of demonstrable COVID-19 viremia. This patient received eight Hemopurifier treatments without complications and eventually was weaned from a ventilator and was discharged from the hospital.
The second patient was notable for the first-ever demonstration of in vivo removal of the SARS-CoV-2 virus from the bloodstream of an infected patient. The patient completed a six-hour Hemopurifier® treatment without complications and subsequently was placed on Continuous Renal Replacement Therapy (CRRT). The patient ultimately expired three hours after being placed on CRRT because of the advanced stage of the disease.
In addition to the two case studies, the safety and feasibility of the Aethlon Hemopurifier® is being evaluated in an active Early Feasibility Study, analogous to a Phase 1 clinical trial for a drug or biologic, that will enroll up to 40 COVID-19 ICU patients [NCT04595903]. The pre-print manuscript is being submitted to peer-reviewed journals, and Aethlon expects it to be published in the near future.
Medtronic to Stop Distribution and Sale of HVAD™ System
On June 03, 2021, Medtronic plc announced that it is stopping the distribution and sale of the Medtronic HVAD™ System. The physicians were notified by the company to cease new implants of the HVAD System and transition to an alternative means of durable mechanical circulatory support.
This action was initiated in light of a growing body of observational clinical comparisons indicating a higher frequency of neurological adverse events, including stroke and mortality, with the HVAD System as compared to other circulatory support devices available to patients.
Nnamdi Njoku, president of the Mechanical Circulatory Support business, which is part of the Cardiovascular Portfolio at Medtronic, said, “The Medtronic Mission guides us to always do what is in the best interests of patients and that is exactly what we are doing and will do for those impacted by this decision. There is nothing more important than the safety and well-being of patients. We recognize this information may be concerning for patients and their caregivers, and Medtronic is committed to supporting them in coordination with their physicians.”
Medtronic is committed to patient safety and serves the needs of the approximately 4,000 HVAD patients currently implanted with the device.
Cognoa Receives FDA Marketing Authorization for First-of-its-kind Autism Diagnosis Aid
On June 02, 2021, Cognoa, a pediatric behavioral health company developing diagnostic and therapeutic solutions for children living with behavioral health conditions, received approval for a De Novo classification request from the U.S. Food and Drug Administration (FDA) for its autism diagnosis aid. The AI-based device is intended for use by healthcare providers as an aid in the diagnosis of autism spectrum disorder (ASD) for patients ages 18 months through 72 months who are at risk for developmental delay based on concerns of a parent, caregiver, or healthcare provider.
Dave Happel, CEO of Cognoa, said, “The current system is already at a breaking point as it is unable to provide early diagnoses and intervention opportunities to many children and families. With rapidly-rising autism rates, this crisis will only worsen without new approaches and innovations. The FDA authorization of our diagnosis aid, Canvas Dx™, is a significant milestone in Cognoa’s development and a crucial step towards making early diagnoses more accessible to children and families – regardless of gender, ethnicity, race, zip code, or socio-economic background. We look forward to partnering with the healthcare community as we introduce Canvas Dx in the coming months.”
ObvioHealth announces a ground-breaking partnership with Dedalus Group to unite real-world & clinical trial data
On June 07, 2021, ObvioHealth, a global virtual research organization (VRO), entered into a new strategic partnership with Dedalus Group, the leading healthcare and diagnostic software solutions provider in Europe. The partnership will be supporting healthcare providers from 6000+ hospitals and clinics across the world to deliver care to more than 330 million patients by uniting ObvioHealth’s proprietary decentralized clinical trial tools with Dedalus’s software solutions and connecting the dots between clinical research and EHR (Electronic Health Record) data.
Ivan Jarry, CEO of ObvioHealth, said, “At a time when personalized medicine is on the rise and the ROI on drug development is declining, we must make research dollars work harder. There is tremendous and rich data available on any number of disease states, comorbidities and biomarkers that can inform clinical trials. The integration of clinical research with the data that sits within EHRs has the potential to be a game changer. Dedalus and ObvioHealth are enabling more precise identification of cohorts for trials while also facilitating longitudinal analyses that can identify new indications and/or long-term impacts of certain treatments.”
Dr. Michael Dahlweid, MD, Ph.D., the Chief Product & Clinical Officer at Dedalus Group, said, “With this partnership, we are aiming to improve translational medicine through a spectrum of options: from decentralized trials…all the way to synthetic trials, leveraging the full potential of existing real-world data to allow for clinical learning and validation of all kinds of therapeutical approaches.”
HistoSonics Announces First Patient Treated in European Clinical Trial
On June 07, 2021, HistoSonics, developer of a non-invasive platform and novel sonic beam therapy, announced that the first patient has been treated as part of the company’s #HOPE4LIVER Europe Trial, which was approved by German authorities earlier in the year.
This study is designed to evaluate the safety and efficacy of the HistoSonics’ platform technology, which uses the novel science of histotripsy and the mechanical properties of therapeutic focused ultrasound, to destroy unwanted tissue, including targeted primary and metastatic liver tumors, without the need for incisions or invasiveness. It is a multi-center, open-label, single-arm trial planned to enroll up to 45 patients throughout Spain, Italy, UK, and Germany and is being run in parallel with a similar US trial.
HistoSonics’ Vice President of Medical Affairs, Joe Amaral, M.D., said, “It is extremely exciting to be working with Professor Pech and the team at Otto con Guericke University Clinic in Magdeburg to build upon the company’s initial success of the THERESA Study conducted in Spain. We believe our non-invasive platform and novel therapy has the potential to change the experience for patients with solid liver tumors, and our aim is to continue to build this evidence with the #HOPE4LIVER Trials. We are very thankful to Professor Pech and the entire team in Magdeburg for their continued commitment to clinical research and providing leadership in this important trial.”
FDA Approves First-of-its-Kind SenSight™ Directional Lead System for DBS Therapy
On June 07, 2021, Medtronic plc received approval from the U.S. Food and Drug Administration (FDA) and performed the first U.S. implants of the SenSight™ Directional Lead System used for Deep Brain Stimulation (DBS) therapy.
SenSight is the first-of-its-kind DBS directional lead that combines the benefits of directionality with the power of sensing, allowing physicians to deliver precise, patient-specific DBS therapy for the treatment of some symptoms associated with movement disorders like Parkinson’s disease, dystonia, and essential tremor, and medically refractory epilepsy.
The system was first implanted at the University of Florida by multi-disciplinary teams in early June, and a full launch in the U.S. will continue immediately. The product also recently received CE Mark and fully launched in Western Europe in March of 2021.
FitTrack Partners with Advanced Human Imaging (AHI) to Integrate New State-of-the-Art Body Scanning
On June 09, 2021, FitTrack entered into a partnership with human imaging company Advanced Human Imaging (AHI) to announce FitScan.
It plans to launch the innovative software in early 2022 across iOS and Android platforms. FitScan will enable its users to check privately, track, accurately assess overall wellness, and predict potential health risks all from their smartphone. The new software will seamlessly integrate into FitTrack’s existing ecosystem, which includes an app and multiple hardware devices, to deliver a complete and holistic perspective of health, wellness, and progress.
The Face Assessment is a non-intrusive and easy-to-use scan for measuring key health parameters, such as heart rate, blood pressure, respiratory rate, and risks associated with cardiovascular disease, heart attacks, and strokes. FitScan’s Body Assessment scan will associate innovative technology and state-of-the-art image processing techniques that return over ten unique insights such as body circumference, body composition, and risk indicators for obesity and type-2 diabetes.
Jeffrey Lee, CEO, and Founder of FitTrack, said, “It has always been my vision to ensure better health outcomes for our customers by making health management simple and sustainable. We want to give our users the tools to take control of their personal health journeys. With AHI as our software partner, we are enabling FitTrack users to use their personal devices to perform simple but cutting-edge health assessments in the safety and comfort of their home. FitScans are self-reported with instant results, at a fraction of the cost of a doctor visit or dexa scan.”
Ibex Granted FDA Breakthrough Device Designation
On June 09, 2021, Ibex Medical Analytics, the pioneer in AI-powered cancer diagnostics, received the Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its Galen platform.
Joseph Mossel, Chief Executive Officer and Co-Founder of Ibex Medical Analytics, said, “We are honored to have been granted the Breakthrough Device Designation. Ibex is committed to providing world-class tools for pathologists to ensure every patient receives a timely and correct diagnosis while supporting pathology labs and health systems to increase efficiency and accuracy. Our Strong AI technology is already in clinical use globally, making a real impact on patient care. We are proud to work closely with the FDA and look forward to continuing to collaborate with the agency as we accelerate our clinical program in the United States.
Medtronic Received FDA Approval of its Next Generation Recharge-Free Spinal Cord Stimulation Platform
On June 10, 2021, Medtronic plc received U.S. Food and Drug Administration (FDA) approval for Vanta™, a high-performance, recharge-free implantable neurostimulator (INS) with a device like that can be optimized for up to 11 years.
The Vanta neurostimulator represents a 10% increase in longevity compared to PrimeAdvanced™, Medtronic’s previous generation recharge-free device. It is also 20% smaller than the PrimeAdvanced neurostimulator, with a more rounded, ergonomic contouring to offer enhanced comfort. It also utilizes Medtronic’s proprietary AdaptiveStim™ technology for personalized pain relief that adapts to the patient’s movement or body position using a built-in accelerometer.
Charlie Covert, vice president, and general manager, Pain Therapies within the Neuromodulation business, which is part of the Neuroscience Portfolio at Medtronic, said, “We are committed to delivering innovative solutions that meets the needs of every patient. For those who prefer or require a recharge-free device, I believe the Vanta neurostimulator offers the best hardware and features available today. We are pleased to offer this solution, which is now part of the strongest and broadest overall portfolio in this market.”