The US FDA now requires mammograms include information about breast density, a significant factor that raises breast cancer risk and can hide tumors.

The US agency said on 10 September that it plans to study whether heavy metals detected in tampons could endanger their users.

Highlights from Medtech Insight's on-the-ground coverage of LSX in Boston. 

Can the new UK government's raw enthusiasm for NHS reform be a catalyst for real change where countless past attempts to address the national provider's shortcomings have failed to hit the spot? And what might the 10-year plan mean for medtech?

Highlights from Medtech Insight's on-the-ground coverage of LSX in Boston. 

Clue Plus members will have access to 50% off a Headspace subscription for tailored guidance, support and validation to help manage cycle-related stress and improve overall well-being.

In this week’s Digital Health Roundup, Medtech Insight’s Ryan Nelson highlights Click Therapeutics’ FDA-cleared digital therapeutics (DTx) for depression and Sinaptica Therapeutics’ personalized neuromodulation for Alzheimer’s patients. Marion Webb discusses her interview with MindMaze’s John Krakauer on their gaming-focused DTx to help people recover from serious brain injuries. Elizabeth Orr introduces new voting members of the new Digital Health Advisory Committee and Natasha Barrow discusses Hello Heart’s new symptom-tracking feature in their heart-focused app.

The Australian teletrials program has surpassed expectations at its mid-way point and is being used by drug and device sponsors looking to enhance trial participant recruitment and retention by enabling access to rural, regional and remote areas.

Centralization and rationalization of the EU’s medtech rules are critical, particularly for conformity assessment and clinical evidence. Hear the views of Tom Melvin and Erik Vollebregt first-hand in a new in-depth interview on regulatory problems and opportunities.

Exact Sciences’ Cologuard at-home colorectal cancer screening test was the first of its kind when it was introduced to the US market in 2014. What’s ahead for the company as its flagship product moves into its second decade? Medical director Paul Limburg spoke to Medtech Insight about the potential of home cancer screening.

The Australian teletrials program has surpassed expectations at its mid-way point and is being used by drug and device sponsors looking to enhance trial participant recruitment and retention by enabling access to rural, regional and remote areas.

During a tour of Truvian’s San Diego headquarters, Medtech Insight spoke with the company’s top executives about their unique three-in-one blood-testing benchtop system, plans for FDA regulatory filing, and marketing strategy.

In this week’s Digital Health Roundup, Medtech Insight’s Ryan Nelson highlights Click Therapeutics’ FDA-cleared digital therapeutics (DTx) for depression and Sinaptica Therapeutics’ personalized neuromodulation for Alzheimer’s patients. Marion Webb discusses her interview with MindMaze’s John Krakauer on their gaming-focused DTx to help people recover from serious brain injuries. Elizabeth Orr introduces new voting members of the new Digital Health Advisory Committee and Natasha Barrow discusses Hello Heart’s new symptom-tracking feature in their heart-focused app.

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights AI discussions at the HLTH Europe conference and an interview with Motif Neurotech's CEO Jacob Robinson. Elizabeth Orr discusses DeepWell DTx's newly launched VR game for treating stress-related hypertension and anxiety. Natasha Barrow provides an overview of Digital Mental Health Technologies regulation in the UK and Brian Bossetta reports ‘the good and bad’ from Medtronic's report on digital technologies' use in the operating room. 

In this episode, Medtech Insight senior reporter Hannah Daniel speaks to DJ Fang, chief operating officer and co-founder of Pure Global. Pure Global uses AI to help device manufacturers navigate global regulations, and we talk about clinical trials, how countries incentivize medtech innovation, and the Biden Administration’s tariffs on some Chinese-made medical devices.

In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.

The US FDA now requires mammograms include information about breast density, a significant factor that raises breast cancer risk and can hide tumors.

The US agency said on 10 September that it plans to study whether heavy metals detected in tampons could endanger their users.

Highlights from Medtech Insight's on-the-ground coverage of LSX in Boston. 

Can the new UK government's raw enthusiasm for NHS reform be a catalyst for real change where countless past attempts to address the national provider's shortcomings have failed to hit the spot? And what might the 10-year plan mean for medtech?

After a hiatus of nearly a year, the EU can celebrate another designation under the IVD Regulation.

Withings is touting the FDA-cleared Sleep Rx Map as an alternative to costly, inconvenient overnight stays in sleep labs, and its solution could be more efficacious than polysomnography due to the longitudinal data it captures, the firm says. There are other at-home tests available for diagnosing sleep apnea, but Withings’ device is contactless.

Venture investment in medtech seems to be improving, particularly in diagnostics and tools, and down-value rounds have decreased. However, interest rates are still much higher than three years ago, and many tech investors continue to avoid the health care sector as a whole.

Smiths Medical has recalled scores of Bivona tracheostomy tubes due to a manufacturing defect that can result in disastrous consequences. The company reports multiple injuries, and one death, linked to the devices.

Haleon will launch Futura Medical's FDA-approved OTC medical device for erectile dysfunction in the US before the end of the year. Already available to pre-order online on Amazon, Eroxon represents the firm's first move into the sexual health category. 

In a letter to US lawmakers, the Association for Diagnostics and Laboratory Medicine says the FDA’s final rule regulating lab-developed tests will stifle innovation and that Congress needs to step in and stop it.

Clue Plus members will have access to 50% off a Headspace subscription for tailored guidance, support and validation to help manage cycle-related stress and improve overall well-being.

Apple is introducing new health features in conjunction with its launch of the Series 10 Apple Watch and AirPods Pro 2 earbuds, which soon will be able to monitor for potential sleep apnea and function as a clinical-grade hearing aid, respectively, pending regulatory clearances in the US and other countries around the globe.