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Sean O´Dowd, Director, Medical Devices/IVD at PharmaLex

Pandemic and supply shortage among factors in slow transition to new rules.

European Commission Adopts Proposal to Delay MDR Deadlines 

The Food and Drug Administration (FDA) has granted expanded 510(k) clearance for multiple sclerosis (MS) assessment with the magnetic resonance imaging (MRI)-based artificial intelligence (AI) software Neurophet AQUA.

Previously FDA-cleared for assessment of brain atrophy on MRI

, Neurophet AQUA offers advanced analysis of MS and white matter hyperintensities based off of T2-weighted fluid-attention inversion recovery (FLAIR) MRI, according to Neurophet, the developer of Neurophet AQUA.

Based off brain MRI images, the AI-enabled software Neurophet AQUA reportedly offers quantification of lesions and structural changes associated with multiple sclerosis (MS) and volumetric brain region assessment without the need for 3D T1 images. The Neurophet AQUA software recently garnered expanded FDA 510(k) clearance for MS assessment. (Image courtesy of Adobe Stock.)

key features of the AI-powered software’s MS analysis

precise assessment of lesion count, volume and progression through enhanced quantification of lesions and structural changes;

volumetric brain region assessment without the need for 3D T1 images; and

bolstered segmentation of T2-weighted FLAIR images at 2D and 3D on 1.5T and 3T MRI platforms.

"MS is a neurological disorder that heavily relies on MRI for both diagnosis and disease monitoring, and the McDonald criteria, the diagnostic criteria for MS, specifically includes MRI confirmation of lesions disseminated in space and time," said Jake Junkil Been, the co-CEO of Neurophet. "Neurophet AQUA's advanced MS analysis technology significantly enhances efficiency and convenience for healthcare professionals, making it an indispensable tool in both diagnostic and prognostic stages."

Through AI technology, Neurophet AQUA now provides multiple sclerosis (MS) analysis with a combination of lesion quantification and enhanced segmentation of T2-FLAIR MRI.

FDA clears AI software for brain MRI for Multiple Sclerosis assessment

Healthcare Information and Management Systems Society (HIMSS) and 

 have recently released their joint research, 

“Early Successes, Untapped Potential, Lingering Questions: Medscape & HIMSS AI Adoption in Healthcare Report 2024.”

 The report demonstrated that, currently, 

 (AI) in health care settings is primarily used for administrative tasks, and applications of AI that are more 

 are still in the early stages of adoption.

Additionally, the report found that most medical facilities have been using AI tools for at least 10 months, and survey respondents expressed their expectations for AI to one day play a larger role in reviewing 

 (EHRs), analyzing medical literature and generally enhancing patient care.

“This report provides valuable insights into AI’s current impact and future potential in health care,” Jon McKenna, executive editor of reports at Medscape, said in an 

. “While AI is making progress, particularly in administrative functions, there’s still progress to be made in expanding its clinical applications and addressing privacy and ethical concerns. The findings highlight the need for increased training and support as health care organizations continue to integrate AI. It’s promising to see the 

 of AI’s potential to enhance patient care and improve efficiency.”

The report also suggests that a significant knowledge gap could develop as AI’s integration into health care progresses. According to the report, just 24% of survey respondents received AI training from their employers. Regarding their biggest hesitations, 72% of respondents considered data privacy to be a major 

 and 70% worry about ethical dilemmas with increased use of AI.

“Health professionals understand that artificial intelligence has the potential to fundamentally change health and health care, from clinical decision-support to operations to patient engagement,” Hal Wolf, president and CEO of HIMSS, said. “However, a critical knowledge gap exists around the effective implementation of AI capabilities. To harness AI’s full potential, practitioners and health system executives must build a digitally mature infrastructure that prioritizes ethical and secure use, ultimately improving patient outcomes and optimizing resource management.”

Respondents who indicated that their medical workplace was already leveraging AI tools were given a list of 19 likely applications and asked to select where AI was currently being used. From this line of questioning, researchers found that administrative tasks topped the in-use-now list, with 36% of respondents answering that their workplace was already using AI to transcribe patient notes and 32% were using AI to transcribe business meetings. In the same vein, 29% of respondents said their workplaces were already using AI to create routine client communications, while 27% and 26% indicated that their workplaces used AI for patient-related recordkeeping and reviewing EHRs.

In terms of clinical applications, 26% of those surveyed said their workplaces use AI to analyze x-rays, computed tomography (CT) scans and other images, and 20% report using AI to analyze non-imaging patient data and test results as well as to assist in patient diagnosis.

In the future, over 40% of those surveyed expect AI assist in reviewing EHRs and other relevant medical literature and data, while still being used for transcription and communications. Many respondents also predict AI will be used more often for clinical purposes, as well as to train physicians on improving patient care.

In total, researchers recruited 846 respondents for the 10-minute online survey. The surveyed population was made up of U.S. executive or clinical leaders, practicing physicians, nurses, other health practitioners or technology professionals.

A new report found that AI in health care settings is primarily used for administrative tasks, with clinical applications still in the early stages of adoption.

How AI is used in health care today — and how it may be used in the future

Microbot Medical Inc. announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration for the Liberty Endovascular Robotic System. According to the company, Liberty is the world’s first single-use, fully disposable robotic system designed to assist clinicians with endovascular procedures.

The submission follows the successful completion of a multi-center, single-arm trial evaluating the performance and safety of Liberty in patients undergoing peripheral vascular interventions. The company anticipates FDA clearance in the second quarter of 2025 and plans to begin commercialization activities shortly afterward.

“This is a pivotal milestone for our company, as the 510(k) submission reflects the commencement of our transition to a commercially focused company,” said Harel Gadot, chairman, CEO and president of Microbot Medical, in a news release. “We are excited to transition our focus towards preparing for our expected U.S. launch in the second quarter of 2025 and targeting the more than 2 million peripheral vascular procedures performed in the U.S. each year.”

The Liberty system does not require large or costly capital equipment, making it potentially more accessible to health care facilities, according to the company. With remote control functionality, it is also designed to reduce radiation exposure for physicians and staff and improve ergonomics during procedures. The company believes Liberty’s single-use format can lower procedure costs and increase efficiency while improving overall care.

"We believe, based on feedback from physicians and the medical community, that Liberty is positioned to redefine the peripheral endovascular space with the introduction of the world’s first commercially available single-use robotic system,” Gadot said.

Microbot Medical, based in Braintree, Mass., is a pre-commercial stage medical technology company focusing on robotics for endovascular interventions.

With remote control functionality, Liberty is designed to reduce radiation exposure for physicians and staff and improve ergonomics during procedures. 

Microbot Medical submits 510(k) to FDA for Liberty endovascular robotic system

HeartBeam, Inc., announced it has received U.S. Food and Drug Administration 510(k) clearance for its HeartBeam system, a credit card-sized device is the first-of-its-kind cable-free ambulatory electrocardiogram (ECG) system cleared for comprehensive arrhythmia assessment, the company said in a news release.

“It’s well documented that patients who delay seeking care for their cardiac symptoms face worse clinical outcomes. The ability for patients to capture high-fidelity ECG signals from three directions wherever they are when symptoms occur will help patients get the care they need in a timelier manner,” said Robert Eno, Chief Executive Officer of HeartBeam in a news release. “The FDA clearance of our technology is a significant milestone for the Company that brings us one step closer to fulfilling our vision of providing unprecedented cardiac insights to individuals and physicians.”

According to the company, the HeartBeam System is a portable non-invasive recorder intended to record, store, and transfer a patient’s 3-Lead (in three-directions) ECG acquired from 5 electrodes. The device is intended to be used by adult patients in either a clinical setting or at home. The device does not conduct cardiac analysis and can be used with an ECG Viewer software system for manual interpretation of non-life-threatening arrhythmias by a physician or other health care professional.

Patients can use the HeartBeam device whenever they experience symptoms, guided by an accompanying smartphone app. The device takes a 30-second ECG recording, which is then uploaded to the cloud for a physician to evaluate. By offering multiple directional views of the heart’s electrical activity, HeartBeam says its system can provide “actionable heart health information.”

As part of its go-to-market strategy, HeartBeam plans to initiate an Early Access Program to gather feedback from patients and physicians prior to a commercial launch.

Future system advancements are also underway, including a personalized transformation matrix to create synthesized 12-lead ECGs and AI-based algorithms aimed at improving arrhythmia detection. The company cites research indicating this technology may improve the identification of heart conditions such as atrial flutter and coronary occlusions.

HeartBeam holds more than a dozen U.S. patents and four international patents related to its ECG technology, according to the news release.

HeartBeam plans to initiate an Early Access Program to gather feedback from patients and physicians prior to a commercial launch. 

HeartBeam secures FDA clearance for at-home ECG system

Onward Medical has received de novo classification and market authorization from the U.S. Food and Drug Administration (FDA) for its ARC-EX System, a non-invasive spinal cord stimulation device designed to improve hand strength and sensation in people with chronic spinal cord injury (SCI).

It is the first FDA-approved technology shown to enhance these functions in patients more than one year post-injury.

“With today’s FDA de novo classification and authorization to market the ARC-EX System in the US, a new era begins for people with chronic spinal cord injury,” said Dave Marver, CEO of Onward Medical, in a news release. “For the first time, there is an approved therapy shown to improve hand strength and sensation after chronic SCI. No longer will people be sent home and told nothing can be done to help them regain these abilities after their injury. We hope this is the first of many therapies we will introduce to help people regain independence from paralysis and other movement disabilities.”

The ARC-EX System delivers electrical stimulation through electrodes placed on the back of the neck and does not require surgical implantation. Results from the Up-LIFT clinical study, published in 

 (2024), showed that 90% of participants experienced improved strength or function, while 87% reported enhanced quality of life. Benefits were observed up to 34 years post-injury and included decreased spasm frequency, better sleep, and improved upper body sensation.

Spinal cord injuries impact about seven million individuals worldwide, including more than 300,000 in the United States. Half of these injuries result in tetraplegia, affecting the function of all four limbs. Beyond immediate loss of motor and sensory function, secondary complications can include incontinence, compromised blood pressure regulation, and diminished sexual function. Treatment costs for tetraplegia can exceed $5 million, underscoring the need for innovative, cost-effective interventions.

“Regaining hand ability is the highest treatment priority for people with paralysis, five-fold higher than regaining all other abilities lost to injury,” said Chet Moritz, PhD, Professor of Rehabilitation Medicine at the University of Washington. “I believe the ARC-EX System will have a tremendous impact on the quality of life of people living with SCI. My clinical and research colleagues in the US are eager and excited to have access to this important breakthrough technology.”

Onward expects to begin offering the ARC-EX System for clinical use in the United States immediately. Home-use authorization is anticipated in mid-2025. The company plans to seek CE Mark certification for commercialization in Europe in early 2025, with authorization expected in the second half of that year. The ARC-EX System was named a TIME Magazine Best Invention in 2024.

Onward is also developing an implantable ARC-IM System and the ARC-BCI System, which integrates a brain-computer interface powered by artificial intelligence.

ARC-EX is the first FDA-approved technology shown to improve hand strength and sensation patients more than one year post-injury.

FDA clears ARC-EX, Onward Medical’s non-invasive spinal cord stimulation system

SonoMotion Inc., a venture-backed medical device company focused on non-invasive kidney stone treatments, announced Nov. 13 it has received de novo clearance from the U.S. Food and Drug Administration for its Stone Clear device.

The approval marks the first device cleared by the FDA that uses external ultrasound pulses to help move and facilitate passage of post-lithotripsy kidney stone fragments without surgery.

“SonoMotion’s goal is to fundamentally change how kidney stones are treated, and securing FDA clearance for Stone Clear is a major milestone toward this goal,” said Oren Levy, Ph.D., co-founder and chief executive officer of SonoMotion, in the statement. “Our technologies have the potential to be a first-line treatment for kidney stones, offering patients an option to avoid anesthesia and reduce wait times for surgery.”

Kidney stones affect one in 10 people in the United States, leading to an estimated $10 billion in annual health care costs, according to the company. Stones can be treated with various methods, including lithotripsy, which breaks them into smaller pieces. However, residual fragments can remain and result in complications, such as emergency department visits or repeat procedures.

Stone Clear is part of a platform designed to move and facilitate the passage of stone fragments without anesthesia in a range of health care settings, including outpatient offices and emergency departments. According to the company, ultrasound propulsion in patients with post-lithotripsy residual fragments reduced the risk of relapse by 70% compared to standard observation. Results from the randomized controlled clinical trial, which included up to five years of follow-up, will be published in the December 2024 issue of the 

"Patients with post-lithotripsy residual fragments are more likely to have complications, emergency department visits, or repeat procedures, yet they have no reliable non-invasive option aside from passive observation," said James E. Lingeman, MD, Clinical Professor of Urology, Indiana University School of Medicine, in a company news release. "The Stone Clear device provides patients with a non-invasive option to reduce their residual fragment stone burden in the clinic environment while being fully awake."

SonoMotion is also developing Break Wave, a second solution that uses focused ultrasound to fragment stones in the upper urinary tract without anesthesia. Break Wave is undergoing clinical trials in the United States and Canada.

Stone Clear is the first and only device cleared by the FDA that uses external ultrasound pulses to facilitate passage of post-lithotripsy kidney stone fragments without surgery.

Sean O´Dowd

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