Insightec, a global healthcare company dedicated to using acoustic energy to transform patient care,  announced it has received an additional FDA approval for treatment of essential tremor using its Exablate Neuro platform.

Essential tremor commonly affects both sides of the body, and this new FDA approval will allow appropriate patients to have their second side treated at least nine months after treatment of the first side.

The Insightec-sponsored study included 51 patients treated at seven leading academic medical centers in the US and evaluated safety and efficacy endpoints out to six months.

Data from the study showed a highly significant reduction in tremor following treatment of the second side. These results were immediate and sustained through at least six months of follow-up, consistent with results from treatment of the first side. Importantly, there was a significant improvement in functional disability, which suggests a clinically meaningful effect in activities of daily living, like eating, drinking, and writing. The majority of adverse events were mild, with a similar safety profile to treatment of the first side.

“This FDA approval is a very important milestone for us and demonstrates our unwavering commitment to expanding the treatment options for people living with essential tremor,” said Maurice R. Ferré, MD, CEO and Chairman of the Board of Directors at Insightec. “It’s very common for patients who’ve benefited from tremor reduction from the first side treatment to ask about having the second side treated. This approval paves the way for them to do that.”

“We are happy to have an option for patients with essential tremor to ultimately receive focused ultrasound treatment on both sides of the brain,” said Michael G. Kaplitt, MD PhD, Professor and Executive Vice-Chair of Neurological Surgery, New York Presbyterian Hospital-Weill Cornell Medicine, and Principal Investigator of this study. “The investigators are working with Insightec to share the full results of the study with the professional community in an academic publication to further help practitioners guide their patients going forward.”

Healthy.io, the global leader in transforming the smartphone camera into a medical device, and Blue Cross of Idaho announced a new multi-year partnership that will provide innovative tools to help Idahoans lead healthier lives by promoting early detection of kidney damage and chronic kidney disease (CKD).

This multi-year collaboration will provide people across the state with access to Healthy.io’s Minuteful Kidney™ test, the only FDA-cleared at-home kidney test. Through this partnership, Blue Cross of Idaho employees and Medicare Advantage members will have an easy way to test for signs of kidney damage, with instant clinical-grade results that are shared directly with their primary care physician.

Beginning this month, test kits will be provided to select Blue Cross of Idaho employees ahead of a broad rollout with Medicare Advantage members in 2023.

Blue Cross of Idaho is at the forefront of closing key care gaps for members. The partnership with Healthy.io will help improve health equity—especially in rural and underserved communities—by increasing access to a critical test for at-risk Medicare Advantage members across Idaho. A recent study found that 38% of rural Idahoans reported their primary care physician was between 25-100 miles from their home.

“Minuteful Kidney plays an important role in improving health equity by increasing access to a critical test that can facilitate the early detection of CKD,” said Paula LeClair, US General Manager of Healthy.io. “We are delighted to be working with Blue Cross of Idaho to put this reliable, easy-to-use test in the palm of so many hands across the state.”

Providing easy-to-use at-home diagnostic tools, such as Healthy.io’s Minuteful Kidney test kits, helps vulnerable communities access much-needed healthcare services that are often out of reach. Healthy.io’s Minuteful Kidney service facilitates early detection of CKD by allowing patients to take the test anywhere they want, at any time.

CKD is referred to as a “silent killer” because it often doesn’t have symptoms until very late stages. One in three Americans is at risk, including those with diabetes and hypertension. Yet most don’t know they have the condition until it progresses to end-stage renal disease, eventually requiring dialysis and/or a kidney transplant.

People at risk for CKD should complete an annual albumin-to-creatinine ratio (ACR) test, yet 80% don’t take the test. Healthy.io’s recent 510(k) clearance from the U.S. Food and Drug Administration (FDA) for home use of the Minuteful Kidney test marks the first time the FDA has granted clearance for a smartphone-powered home test to determine ACR. Now, patients can take a clinical-grade ACR test at their preferred time and location, with a simple smartphone scan. This is the first and only home test that allows patients to get immediate results without sending a sample to the lab.

Brain Scientific, a Florida-based applied science technology company, announces a new distribution agreement with MVAP Medical Supplies to drive sales into the rapidly growing and underserved pediatric EEG marketplace.

“For pediatric EEGs, Brain Scientific’s innovative NeuroCapTM – which shortens EEG setup times and provides staff and patients with more ease of use and comfort – is a perfect fit,” said Eric Jensen, CEO of MVAP Medical Supplies. “As anyone who has tried to get a child to sit still through an hourlong procedure knows, patient comfort and speed of application are paramount in the pediatric space. They’ve hit the sweet spot our customers have been looking for.”

MVAP Medical Supplies, an industry leader in the sleep, EEG, EMG, IOM, respiratory and patient care supplies space, will help Brain Scientific further expand its sales and distribution network to key growth markets as Brain Scientific continues to position itself as the leader in the quickly emerging medical wearables space.

“We designed the NeuroCap to be game-changing in the neurodiagnostic wearable space. It has critical applications in pediatrics, emergency and ICUs, at-home care and research,” said Hassan Kotob, CEO of Brain Scientific. “We are excited to have MVAP Medical Supplies with us on our journey to becoming the leading medical wearables provider on the planet.”

The signing of MVAP Medical Supplies comes on the heels of the addition of Fulcrum and D&D Medical, both aimed at expanding the reach of Brain Scientific’s wearable products into key strategic markets.

Accenture has made a strategic investment, through Accenture Ventures, in BehaVR, a leading innovator in virtual reality (VR) digital wellness and digital therapeutics experiences.

On the same day, BehaVR announced a merger with OxfordVR, a spin-out of Oxford University and a leader in science-based virtual reality treatments for serious mental illnesses. The newly combined entity will offer comprehensive, cross-acuity, VR-based therapeutic interventions for mental health, part of a digital therapeutics market expected to exceed $13B by 2027.

Through its proprietary delivery platform for creating, validating, and operating digital therapeutics solutions, the BehaVR platform enables personalized, dynamic experiences that are governed and adapted in real-time based on biometrics, protocols, and machine learning models.

Healthcare leaders expect virtual reality and the metaverse to positively impact the future of care, according to the Accenture Digital Health Technology Vision 2022 report, which explains how more meaningful, tailored experiences can further humanize healthcare by aligning the right technology, operating model, data, and culture to deliver more efficient and empathetic care.

“Providing people with the flexibility to decide when, where, and how they want to receive mental health care will help to improve access, experience, and outcomes,” said Rich Birhanzel, senior managing director and Health practice global lead at Accenture. “BehaVR offers people choice and clinicians options to expand how they care for patients.”

BehaVR is now part of Accenture Ventures’ Project Spotlight, an engagement and investment program that connects emerging technology startups with the Global 2000 to fill strategic innovation gaps. Project Spotlight offers extensive access to Accenture’s domain expertise and its enterprise clients, helping startups harness human creativity and deliver on the promise of their technology.

“Mental health issues in the U.S. and around the world have never been more prevalent, and there is an urgent need for increased resources and treatment,” said Tom Lounibos, managing director, Accenture Ventures. “BehaVR is using the immersive power of virtual reality to activate and rewire neural pathways to treat people suffering from anxiety, stress, fear and other conditions.”

“Around the world, providers and employers are grappling with how to enhance the depth, breadth and efficacy of their mental health service offerings, and we believe virtual reality-based digital therapeutics can play a vital role in helping them do all of those things,” said Aaron Gani, founder and CEO of BehaVR. “Joining Accenture Ventures’ Project Spotlight is a powerful way to drive increased awareness of BehaVR’s VR-powered mental health services as we continue our work to lower barriers and deliver advanced care to the people that so desperately need it.”

Anumana, Inc., an AI-driven health technology company and portfolio company of nference, has entered into a multi-year agreement with Pfizer, Inc. for Anumana to develop an artificial intelligence electrocardiogram algorithm (AI-ECG) designed to enable the early suspicion of cardiac amyloidosis. Anumana will conduct a clinical validation trial and pursue De Novo classification for the algorithm as a Software-as-a-Medical-Device (SaMD) and aims to gain regulatory approval for the algorithm as an SaMD for the detection of cardiac amyloidosis in the U.S., Europe and Japan.

Cardiac amyloidosis is a serious, progressive, and underdiagnosed rare disease that leads to heart failure.1 In patients with cardiac amyloidosis, the heart walls become stiff, making it difficult for the left ventricle to properly relax and fill with blood, while at the same time hampering its ability to squeeze and pump blood out of the heart. Symptoms and comorbidities associated with cardiac amyloidosis, such as shortness of breath, knee pain, bilateral carpal tunnel syndrome, kidney disease, and gastrointestinal issues, can vary and seem unrelated, making diagnosis difficult.2,3

“The challenge in diagnosing cardiac amyloidosis can prevent patients from getting treatment while the disease continues to progress,” said David McMullin, chief business officer of Anumana. “We believe this collaboration will demonstrate the power of Anumana’s AI-ECG algorithms to help clinicians intervene earlier, giving them greater ability to improve patient outcomes and prolong lives.”

The research agreement with Pfizer will help deepen Anumana’s efforts to implement AI-enabled early detection software that can reveal signals from ECGs that humans cannot interpret. The ubiquitous nature of the painless, non-invasive 100-year-old ECG test gives AI-ECG algorithms the potential to reach a larger number of patients earlier.

“AI-ECG solutions alert clinicians to humanly imperceptible patterns in ECG signals, providing an early warning for serious occult or impending disease,” said Paul Friedman, M.D., Chair of the Department of Cardiovascular Medicine at Mayo Clinic and Chair of Anumana’s Mayo Clinic Board of Advisors. “This stands to improve the lives of people with cardiac amyloidosis by improving the speed of triage and care of this group.”

Anumana was founded in 2021 in collaboration with the Mayo Clinic Platform. Anumana has licensed Mayo Clinic AI-ECG algorithms for low ejection fraction, pulmonary hypertension, and hyperkalemia, all of which have received Breakthrough Device Designation from the U.S. FDA. These algorithms have been validated by over 75 peer-reviewed publications, including a first of its kind prospective clinical impact study on low ventricular ejection fraction that was published in Nature Medicine in 2021, and another first of its kind batch enrolled prospective clinical impact study that demonstrated the effectiveness of AI-ECG to screen for undetected atrial fibrillation in normal sinus rhythm that was published in The Lancet in 2022.

Medtronic plc, a global healthcare technology leader, announced the first patient enrolled in the Expand URO U.S. clinical trial for the Hugo™ robotic-assisted surgery (RAS) system. The robotic-assisted prostatectomy procedure was performed by Dr. Michael R. Abern at Duke University Hospital in Durham, N.C.

“This is an exciting moment,” said Dr. Abern. Robotic-assisted surgery provides many benefits within my specialty of urology, and I’m proud to have performed the first U.S. clinical trial case with the Medtronic Hugo RAS system.

Minimally invasive surgery, including robotic-assisted surgery, offers fewer complications, shorter hospital stays, faster return to normal activities, and smaller scars.1–3,† Urologic procedures are one of the most commonly performed with the assistance of a surgical robot. The Hugo™ RAS system is intended to be used in this study for urologic surgical procedures including radical prostatectomy, radical cystectomy, and nephrectomy (partial or radical) procedures at sites in the U.S.

Scientific evidence is the bedrock of healthcare technology innovation and adoption. It creates and builds trust among clinicians and patients,” said Carla Peron, M.D., chief medical officer of the Surgical Robotics business, which is part of the Medical Surgical Portfolio at Medtronic. “We’re proud to further that important pursuit with the Hugo RAS system in partnership with hospitals and surgical teams in the United States who share our commitment to patients.”

The Expand URO clinical trial is being conducted pursuant to an Investigational Device Exemption from the U.S. Food and Drug Administration (FDA). Up to 122 patients will be enrolled in the study at six sites in the U.S.

Dr. James Porter, a urologic surgeon at Swedish Medical Center in Seattle, WA, is the principal investigator of the U.S. Expand URO study.

“This is an exciting time for healthcare in the United States and around the world, as we have the opportunity to expand robotic-assisted surgery treatment options to more patients,” said Dr. Porter, who plans to perform his first cases under the trial this month. “Backed by a growing body of clinical evidence, robotic-assisted surgery is the preferred approach within urology given the anatomical access, precision, and ergonomic advantages it enables.”4

The Hugo™ RAS system, combined with Touch Surgery™ Enterprise,‡ offers a smart, digitally enabled surgical experience. Outside the U.S., it is in use at hospitals across three continents in a range of procedures within urology, gynecology, and general surgery.

The Hugo™ RAS system is commercially available in certain geographies. Regulatory requirements and status in individual countries and regions will determine market availability of the Hugo™ RAS system and approved indications. In the U.S., the Hugo™ RAS system is an investigational device not for sale.