Device manufacturers still have a low level of cybersecurity maturity, but larger companies seem to be doing better than smaller ones.

Medicines and Healthcare products Regulatory Agency’s four week consultation is targeted at improved safety for certain high-risk in vitro diagnostics.

Virtual care leaders at Providence and Sanford Health shared successes and challenges in implementing remote monitoring and telehealth programs during a panel discussion at the recent Reuters Digital Health conference in San Diego.

A recent survey by trade group TEAM-NB found that the number of certificates issued under the IVDR and MDR doubled between 2022 and 2023. However, application completeness remained an issue, with notified bodies estimating that a third of applications were less than 25% complete.

Click will fold Better Therapeutics’ FDA-cleared AspyreRx prescription digital therapeutic into R&D for its own CT-181, which promises to optimize obesity treatment in combination with drugs such as GLP-1s and provide "valuable real-world data insights for providers and payers." Better Therapeutics shuttered its operations in March, signaling continued challenges for digital medicine innovators.

Virtual care leaders at Providence and Sanford Health shared successes and challenges in implementing remote monitoring and telehealth programs during a panel discussion at the recent Reuters Digital Health conference in San Diego.

A study by French device firm Volta found an AI-guided ablation procedure was more effective in treating patients with atrial fibrillation, especially those whose symptoms had persisted for six months or longer.

Dexcom launches its highly customizable One+ continuous glucose monitor in the UK as well as a state of type 2 report that suggests 63% of people living with type 2 diabetes have trouble managing their disease.

Swiss-based start-up DeepPsy aims to streamline mental health care using EEG and ECG biomarkers to better match depression patients with treatments. Co-founder Mateo de Bardeci discusses the company’s vision as it launches its in-house medical device as a service in Switzerland.

Motif’s “pea-sized” Digitally programmable Over-brain Therapeutic (DOT) requires 20 minutes to implant and can be activated at home with a wearable to “lift the fog” for people with depression. Motif CEO Jacob Robinson believes data captured by brain-computer interfaces and continuous monitoring will eventually be able to identify key biomarkers that enable psychiatrists to head off mental health crises.

To avoid a wider health equity gap for home-use devices, companies should make social determinants of health a key consideration in device development, former nurse Amy Hester says.

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.

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.

Device manufacturers still have a low level of cybersecurity maturity, but larger companies seem to be doing better than smaller ones.

Click will fold Better Therapeutics’ FDA-cleared AspyreRx prescription digital therapeutic into R&D for its own CT-181, which promises to optimize obesity treatment in combination with drugs such as GLP-1s and provide "valuable real-world data insights for providers and payers." Better Therapeutics shuttered its operations in March, signaling continued challenges for digital medicine innovators.

Medicines and Healthcare products Regulatory Agency’s four week consultation is targeted at improved safety for certain high-risk in vitro diagnostics.

Virtual care leaders at Providence and Sanford Health shared successes and challenges in implementing remote monitoring and telehealth programs during a panel discussion at the recent Reuters Digital Health conference in San Diego.

A recent survey by trade group TEAM-NB found that the number of certificates issued under the IVDR and MDR doubled between 2022 and 2023. However, application completeness remained an issue, with notified bodies estimating that a third of applications were less than 25% complete.

The MHRA issued a statement on 21 May setting out its draft policy for UK recognition of international regulators’ approvals of medical devices. This will apply in Great Britain, with full implementation expected by 2025.

Swiss-based start-up DeepPsy aims to streamline mental health care using EEG and ECG biomarkers to better match depression patients with treatments. Co-founder Mateo de Bardeci discusses the company’s vision as it launches its in-house medical device as a service in Switzerland.

A study by French device firm Volta found an AI-guided ablation procedure was more effective in treating patients with atrial fibrillation, especially those whose symptoms had persisted for six months or longer.

AI regulation experts discussed the pros and cons of AI “nutrition labels” for transparency, international harmonization of AI regulation and – of course—PCCPs at a recent summit.

Dexcom launches its highly customizable One+ continuous glucose monitor in the UK as well as a state of type 2 report that suggests 63% of people living with type 2 diabetes have trouble managing their disease.

In a speech last week, former US FDA Commissioner Scott Gottlieb said establishing dynamic tools, including active registries and firm-based regulation, will be crucial to the FDA’s ability to regulate emerging technologies. 

Abbott has issued a recall of several hundred HeartMate 3 pumps used to support patients with heart failure after reports of blood leakage and air entering the devices.