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On The Brain
Several brain-computer interface (BCI) developers have made headlines in May.
Synchron announced it teamed up with Apple to develop technologies that one day will allow people who can’t use their hands or voice to control iPhones, iPads and other Apple devices by using only their thoughts.
Synchron was first to bring its BCI into clinical trials. The company has worked with Apple’s team before. In one video, released nine months ago, the BCI developer showed how a 64-year-old-man with amyotrophic lateral sclerosis (ALS), who has been implanted with Synchron’s BCI Stentrode, used his thoughts to control the cursor of an Apple Vision Pro.
Apple built a standard that it hopes will detect intentions from decoded brain signals without the user making specific movements.
Another BCI company, Axoft announced plans to sell its BCI-enabling material Fleuron to researchers and private organizations for R&D use.
Axoft’s CEO Paul Le Floch told Medtech Insight that the material can be used for a wide range of applications amid its unique properties – Fleuron is 10,000 times softer than the polyimide used in existing BCIs, and therefore, he believes, will enable the development of a new class of BCI that is safer, more conformal and longer-lasting in the brain. Meanwhile, Axoft continues developing its own soft-BCI device to help coma patients with covert consciousness communicate.
Neurotechnology start-up Subsense came out of stealth with $17m in seed funding to develop a nonsurgical, nanoparticle-based BCI.
While many other implants require surgical intervention or minimally invasive intervention, Subsense is taking an entirely nonsurgical approach leveraging biocompatible nanoparticles that will be introduced like a spray into the nasal cavity and then directed via external electromagnetic stimulation to specific regions in the brain, enabling recording and stimulation of neural activity. Text
AI Agents For Regulatory Compliance
Boston-based startup Ketryx has launched what it calls the first validated AI agents built specifically for regulated industries like medtech. The AI agents aim to automate compliance tasks and offload labor-intensive activities such as documentation, risk analysis and change management. while maintaining audit readiness and human oversight.
These agents are designed to offload labor-intensive activities such as documentation, risk analysis, and change management, which traditionally slow down product development cycles.
Ketryx founder and CEO Erez Kaminski said the platform was developed to resolve the core tension between safety assurance and innovation speed. Unlike generic AI copilots, Ketryx’s agents are pre-validated for specific regulatory tasks and are engineered to meet standards such as Good Automated Manufacturing Practice and IEC 62304. They include traceable logs, stress-tested outputs, and performance verification to ensure audit compliance.
The agents integrate with platforms like Jira, GitHub, and Polarion, enabling real-time generation of regulatory documentation without forcing teams to change their workflows. Early use cases include complaint classification, redundancy detection, anomaly review, and test coverage analysis.
Customers such as Aignostics and Nutrino Health have reported up to 90% reductions in documentation-related workloads, allowing teams to accelerate releases while maintaining regulatory rigor. Ketryx’s AI architecture grounds large language models in domain-specific data and customer-specific standard operating procedure, ensuring outputs are traceable and customizable.
With expansion plans into postmarket surveillance, clinical trials, FDA submissions, and manufacturing compliance, the company is positioning its platform as a blueprint for scalable regulatory automation across safety-critical industries.
Long-term, Kaminski sees validated AI agents becoming a regulatory expectation rather than a competitive edge, marking the beginning of what he calls “zero-lag safety” — where compliance, detection, and remediation are virtually real-time.
The Value Of Consumer Wearables
People are dictating their health based on wearables, but the clinical value of the data is still unclear, said Professor Dipak Kotecha, a consultant cardiologist and professor of cardiology at the University of Birmingham.
In an interview with Medtech Insight, Kotecha explained that consumer tech wearables have huge potential to inform clinical practice. However, he said there is a lack of proper scientific evidence, such as data from randomized clinical trials, to assess how valuable the products really are.
Providing some context, he explained that some wearables use photoplethysmography (PPG) rather than electrocardiogram (ECG) to measure heart rate. PPG is not as effective in the detection of atrial fibrillation. “You need to do follow-up tests,” he said.
In some cases, wearables can even be damaging to the patient.
“I have also had to tell people to stop using these devices because it is causing them harm.” The wearable is causing anxiety or being used the wrong way, and it’s led to “potential psychological detriment,” Kotecha said.
AdvaMed’s ‘AI Roadmap’
To keep pace with the advancements in digital health, AdvaMed launched a digital health tech division in October 2023. And last month, members of the division’s board of directors held a press conference to discuss its “AI Roadmap” — which is aimed to help lawmakers navigate regulating the complexities of AI and digital technologies through challenging times.
In its roadmap, AdvaMed recommends policies and steps for lawmakers to consider in crafting legislation and regulatory perimeters going forward.
For instance, it encourages policymakers to protect data without stifling innovation; evaluate the need to update the Health Insurance Portability and Accountability Act (HIPAA) for the AI era and create clear guidelines specifically for data use in AI development; and develop appropriate guidelines around patient notice and authorization for the data used to develop AI.
FDA Moves Forward With AI Review
AI will be used in scientific reviews across the FDA by the end of June. FDA commissioner Martin Makary recently directed the FDA’s centers to start deploying a secure, unified AI platform immediately, with a goal of full integration by 30 June.
The rollout follows a successful pilot program testing use of generative AI by scientific reviewers.
The FDA says the tool will allow scientists and subject-matter experts to automate repetitive tasks, cutting the time for some functions from days to mere minutes. Joe Franklin, a special counsel at law firm Covington & Burling and former FDA policy director, told Medtech Insight that thoughtful use of AI could significantly help reviewers in rapid analysis of technical documentation and other time-consuming functions.
Additionally, the new use of AI may help to replace the thousands of employees recently cut from the FDA. While product reviewers were largely spared, the cutbacks in administrative staff could take them away from core job functions. Former device center head Jeffrey Shuren predicted in a recent webinar that AI use could help minimize delays to product reviews.
South Korea Establishes Digital Health Rules
A new law in South Korea has strengthened the country’s regulatory approach for digital health products, two attorneys from Seoul-based Barun Law said during a recent webinar that was co-hosted by US law firm Arnall Golden Gregory.
The Digital Medical Products Act, which came into effect on 25 January, applies to a wide range of advanced equipment including AI, robotics, and communication technology. It is used to diagnose, treat or monitor a disease, as well as digital health products, and also used to predict a patient’s response to treatment or support rehabilitation. The act covers new technologies as well as products already regulated as devices and is intended to reflect the growing importance of AI-driven and software-based healthcare solutions, Barun partner Eun-jin Jang explained.
In addition to the Digital Products Act, devices that store or transmit biometric data must comply with the Personal Information Protection Act, while devices with Bluetooth or Wi-Fi functionality should be certified under the Radio Waves Act.
