Medical device manufacturing and design is a complex process as the products not only need to be precise and user-friendly but also meet the medical industry’s regulatory requirements and deliver ...

Dr Paul Campbell, head of software and AI at the MHRA, said in a recent webinar that AIaMD has the potential to "fix some of ...

Older medical devices with unsupported software pose cybersecurity threats that regulators and industry are struggling to solve. Here are four steps experts say can help mitigate risks.

With the rise of interest around AI since the release of large language models (LLMs), there is pressure on MedTech executives to get ahead of industry peers regarding AI, not only within devices but ...

As with all AI applications, the risks stem from bad or biased data. Medical research has historically suffered from the ...

It’s not a time to do the minimum. Medical device cybersecurity is volatile and constantly changing, so your strategy must be ...

Medical device companies are dealing with the impact of increasing regulations in a number of ways, including the ...

As a result, rather than the hardware QUH designation for an OTC self-fitting hearing aid, the FDA has designated the AirPods Pro 2 as an OTC self-fitting hearing under the software-as-medical device ...

The main difference between AirPods and traditional OTC or prescription hearing aids is that AirPods Pro uses a system called ...

According to DeepWell DTx, there’s a scientific explanation for why our brains might feel just a bit better after a quick ...

An upcoming Apple software update will allow some AirPods to double as over-the-counter hearing aids. Only 1 in 6 American adults with hearing loss wears hearing aids.

According to the FDA, over 30 million Americans report some degree of hearing loss. Through Apple’s new mobile feature, users ...