Masimo receives US regulatory clearance for Stork OTC baby monitoring system six months after Owlet received first clearance for its Dream Sock following a regulatory stumble which halted sales of a previous device, Smart Sock, in 2021.

In this episode, Medtech Insight senior reporter Hannah Daniel speaks to Mark Brown, Global Managing Director of Digital Trust Consulting at the British Standards Institute about digital trust. In a world of cybersecurity breaches and ransomware attacks on hospitals, digital trust between companies and consumers is key, but current siloed operations can hinder that. We talk about the EU’s AI act, the speed of digital transformation, cybersecurity incentives, and how principle-based regulations are better than prescriptive ones.

EU announces the third designation under the MDR in a month.

With much at stake as the UK closes in on national elections, healthtech manufacturers have issued their own manifesto setting out how political leaders can be winners for patients and industry.   

In this episode, Medtech Insight senior reporter Hannah Daniel speaks to Mark Brown, Global Managing Director of Digital Trust Consulting at the British Standards Institute about digital trust. In a world of cybersecurity breaches and ransomware attacks on hospitals, digital trust between companies and consumers is key, but current siloed operations can hinder that. We talk about the EU’s AI act, the speed of digital transformation, cybersecurity incentives, and how principle-based regulations are better than prescriptive ones.

CGM company GlucoTrack Inc. recently announced plans to expand measuring glucose into the spinal epidural space for patients with painful diabetic neuropathy and develop new computational data to support sensor longevity beyond three years from currently two years. Medtech Insight spoke with GlucoTrack’s CEO, Paul Goode, about the company's ambitions to offer more choice in glucose monitoring to people with diabetes.

Teal Health reached a significant milestone in its mission to bring a prescription-based, at-home, self-collect cervical cancer screening device to market.

The designation makes the watch's AFib history feature the first digital health tool to be qualified under the US FDA’s Medical Device Development Tools program, meaning it can be used in research during the development of certain cardiac devices.

As a biomedical engineer, Blair Hirst saw how health technology could help patients – and how some communities were slowest to benefit. As founder of the Digital Health Review, she now works to improve equity in health care spaces.

In this episode, Medtech Insight senior reporter Hannah Daniel speaks to Mark Brown, Global Managing Director of Digital Trust Consulting at the British Standards Institute about digital trust. In a world of cybersecurity breaches and ransomware attacks on hospitals, digital trust between companies and consumers is key, but current siloed operations can hinder that. We talk about the EU’s AI act, the speed of digital transformation, cybersecurity incentives, and how principle-based regulations are better than prescriptive ones.

CGM company GlucoTrack Inc. recently announced plans to expand measuring glucose into the spinal epidural space for patients with painful diabetic neuropathy and develop new computational data to support sensor longevity beyond three years from currently two years. Medtech Insight spoke with GlucoTrack’s CEO, Paul Goode, about the company's ambitions to offer more choice in glucose monitoring to people with diabetes.

Now that the US FDA has published its final rule regulating lab developed tests, litigation challenging the rule and the FDA’s authority to enact it is sure to follow. And the central argument will likely focus on whether the tests are defined as medical devices, which the agency regulates without question.

In this episode, Medtech Insight senior reporter Hannah Daniel speaks to Mark Brown, Global Managing Director of Digital Trust Consulting at the British Standards Institute about digital trust. In a world of cybersecurity breaches and ransomware attacks on hospitals, digital trust between companies and consumers is key, but current siloed operations can hinder that. We talk about the EU’s AI act, the speed of digital transformation, cybersecurity incentives, and how principle-based regulations are better than prescriptive ones.

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights key interviews with Philips’ CEO Roy Jakobs on NAM’s framework on AI, BD’s CTO Beth McCombs R&D initiatives and HSS spine co-chair Sheeraz Qureshi on his vision for integrating AI tech. Hannah Daniel discusses the FDA’s new initiative to create an idea lab for medical device use at home and a new feature on the Apple Watch to help people with Parkinson's disease overcome freezing gait.   

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights her interview with Verily’s CMO and CSO, Andrew Trister at ViVE on leveraging AI for precision health and a DHIS West conference panel discussion on use cases of generative AI. Elizabeth Orr discusses the impact on the newly adopted EU AI Act on device makers and concerns raised by industry members.

Masimo receives US regulatory clearance for Stork OTC baby monitoring system six months after Owlet received first clearance for its Dream Sock following a regulatory stumble which halted sales of a previous device, Smart Sock, in 2021.

In this episode, Medtech Insight senior reporter Hannah Daniel speaks to Mark Brown, Global Managing Director of Digital Trust Consulting at the British Standards Institute about digital trust. In a world of cybersecurity breaches and ransomware attacks on hospitals, digital trust between companies and consumers is key, but current siloed operations can hinder that. We talk about the EU’s AI act, the speed of digital transformation, cybersecurity incentives, and how principle-based regulations are better than prescriptive ones.

CGM company GlucoTrack Inc. recently announced plans to expand measuring glucose into the spinal epidural space for patients with painful diabetic neuropathy and develop new computational data to support sensor longevity beyond three years from currently two years. Medtech Insight spoke with GlucoTrack’s CEO, Paul Goode, about the company's ambitions to offer more choice in glucose monitoring to people with diabetes.

EU announces the third designation under the MDR in a month.

With much at stake as the UK closes in on national elections, healthtech manufacturers have issued their own manifesto setting out how political leaders can be winners for patients and industry.   

The US Food and Drug Administration released eight warning letters and one close-out last month. Big names caught in the net included Beckman Coulter, Royal Philips and Cardinal Health.

Now that the US FDA has published its final rule regulating lab developed tests, litigation challenging the rule and the FDA’s authority to enact it is sure to follow. And the central argument will likely focus on whether the tests are defined as medical devices, which the agency regulates without question.

Teal Health reached a significant milestone in its mission to bring a prescription-based, at-home, self-collect cervical cancer screening device to market.

The Netherlands’ Central Committee on Research Involving Human Subjects is gauging sponsor demand for a new scientific advice service for clinical trials, which is for now free of charge.

UK devices regulator signals near-term progress on PMS statutory instrument, policy statement on international recognition and input into IMDRF project to update  global diagnostics guidance.

The designation makes the watch's AFib history feature the first digital health tool to be qualified under the US FDA’s Medical Device Development Tools program, meaning it can be used in research during the development of certain cardiac devices.

Johns Hopkins professor Tinglong Dai says a subscription model for AI is the most sustainable model for reimbursement.