Data has become overwhelming in healthcare. While it has provided tremendous solutions and outcomes, however, it can sometimes be a problem, too! How can data utilization in Clinical Studies and a ground up data strategy help make your technologies, your team, and your trials more efficient?
FDA clearance of the BCL System will give surgeons access to precise information about each breast tumor that has never before been available to them, according to the company.
Iran-linked hackers claim cyberattack launched against U.S. medtech company Stryker.
Cloud-based SaMD (Software as a Medical Device) designed to assist healthcare providers in predicting delivery date using ultrasound imaging
While some wearables may be tailor made for trial use, they face challenges translating to real-world patient applications outside of a stringent trial setting, and vice versa. This creates a unique challenge for med-devs looking to bring their devices out of the trial setting and into patient care.
The next phase of digital mental health adoption depends less on innovation and more on how the industry uses real-world evidence, builds reimbursement frameworks, and applies regulatory precedent to accelerate scale.
Artificial intelligence is moving quickly into mainstream medical devices, and the industry has become fluent in a familiar set of concerns: bias, transparency, and cybersecurity. These topics matter, but they don’t capture the risks most likely to shape patient safety in the coming decade. The deeper challenges lie in the interactions between algorithms, clinical workflows, data pipelines, and human decision making. Those interactions are where safety is won or lost, and they remain the least examined part of AI adoption.
In the current Cyber Threat environment, companies must have strong cyber liability insurance. Policies must specifically account for cyber-physical risks and the substantial costs of post-market remediation, including mandatory software patches and patient notifications. Insurers are well aware of the 524B mandate and are increasingly requiring proof of compliance before issuing coverage or offering favorable rates. How do you assure your cyber risk plan insurable?
A recent survey of 2,000 UK patients found one in four patients (24%) already use AI for health guidance, and nearly one in three (30%) would be willing to consult AI or social media rather than wait to see a clinician. What needs to happen to ensure AI adoption genuinely empowers patients rather than adding further complexity?
The initial fear that the artificial intelligence and machine learning evolution will replace humans is shifting. A new narrative recognizes the potential for an AI-enabled workforce — one where the technology is a jobs creator, enabling us all to be more productive rather than making millions of people redundant or obsolete — actually giving rise to the multi-disciplinary, power employee.
