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Featured Stories

Inbrain Has Sights On Parkinson’s Following First-In-Human Test Of Graphene-Based Implant

Spain-based Inbrain Neuroelectronics plans first-in-human study to show safety of its graphene-based technology in direct contact with human brain while also developing a second interface for treating Parkinson’s disease.

Neurology Innovation Artificial Intelligence

EURLs Go Live: A New Era For High-Risk IVDs

There is to be more rigorous testing from now on for high-risk IVDs. Measures are also in place to prevent device shortages during the transition to new rules.

Europe EU In Vitro Diagnostics

Latest Philips Recall Linked To Death, Injuries

Philips has issued a recall of various Trilogy ventilators due to safety issues that may affect their ability to properly function. The US FDA has designated the recall class I, its most serious.

FDA Recalls Respiratory

Owkin Teams With AstraZeneca To Develop AI-Based Breast Cancer Prescreening Tool

Biopharmaceutical giant AstraZeneca has partnered with start-up “unicorn” Owkin to develop an AI-powered tool to prescreen for gBRCA mutations on the basis of morphological features in digitized pathology slides. Built on extensive, high-quality data sourced from the France-based PortrAIt consortium, the AI will help to prioritize patients for further testing, streamlining the diagnostic process, Owkin says.

Deals Research & Development Diagnostics

Spotlight On Conferences

European IVD Industry On Rocky Road; Veer Toward 'Pockets of Growth'

Despite challenges and projected European decline, the in vitro diagnostics market has enticing "pockets for growth" post-pandemic, industry leaders revealed at the MedTech Forum conference. Key drivers include healthcare decentralization and consumer pull for control over health. Opportunities exist in neurology, oncology, and direct-to-consumer testing.

Europe EU

Medtech Insight Podcasts


This Episode:

Cardio Conversations: ‘Much More Than Just A Patch.’ iRhythm CEO Blackford Talks AI Arrhythmia Diagnostics
 

Listen to Medtech Insight podcasts for our perspectives on regulation, policy, quality, R&D and key commercial topics.

More Podcasts

Global Device Regulation

Warning Letters – September 2024

The US Food and Drug Administration released three warning letters last month, two of which went to Chinese device testing labs accused of improper treatment of laboratory animals.

Regulation Warning Letters

Research Finds AI Stethoscopes Detect Heart Failure Signs

The results from a trio of studies show that AI-powered digital stethoscopes are effective at identifying patients at elevated risk of experiencing heart attacks and other major cardiac adverse events, according to Eko Health, whose technology was used to screen the participants in the studies.

Artificial Intelligence Cardiology

Modernizing Medical Device Design Control: From Waterfalls to a New Landscape

The regulatory, industrial and methodological changes applied to the medtech sector since the introduction of the US Food and Drug Administration’s design control guidance in 1997 are many and varied. Dr. Stuart Grant of Archetype MedTech looks at the challenges these changes present to both innovators and regulators and how the industry needs to adapt.

Market Access Regulation

Global Medtech Guidance Tracker: September 2024

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

Guidance Documents Regulation
Digital Health

Research Finds AI Stethoscopes Detect Heart Failure Signs

The results from a trio of studies show that AI-powered digital stethoscopes are effective at identifying patients at elevated risk of experiencing heart attacks and other major cardiac adverse events, according to Eko Health, whose technology was used to screen the participants in the studies.

Artificial Intelligence Cardiology

Empowering Primary Care Physicians With Digital Biomarkers For Early Alzheimer’s Detection

Altoida CEO Mark Jones has high hopes that the company’s digital assessment tool will be approved by the FDA to be used along with blood biomarker testing by primary care doctors to help predict Alzheimer’s disease before patients show symptoms.

Digital Health Neurology

Altoida’s Vision For Alzheimer’s Care Combines Digital Screening, Blood-Based Tests, New Drugs

Altoida CEO Marc Jones spoke with Medtech Insight about the company’s investigational digital screening tool for Alzheimer’s and the dire need for better, more accessible precision neurology diagnostics as the global population ages, neurologist shortages worsen, and groundbreaking Alzheimer’s drugs change the treatment paradigm.

Exec Chats LSX

‘Glass Cockpit Project’ Model For Home-Use Devices, Califf Says

In recent conference presentations, the US FDA commissioner has highlighted a NASA project to standardize cockpit layouts as a model that the device center’s home health initiative may follow.

FDA Leadership
See All
Interviews

Inbrain Has Sights On Parkinson’s Following First-In-Human Test Of Graphene-Based Implant

Spain-based Inbrain Neuroelectronics plans first-in-human study to show safety of its graphene-based technology in direct contact with human brain while also developing a second interface for treating Parkinson’s disease.

Neurology Innovation

Genetic Analysis Leaders On Gut Microbiota Testing, Pharma Connections And Direct-To-Consumer Scene

Genetic Analysis CEO Ronny Hermansen and Christina Casén, senior VP of clinical and medical affairs, discuss the company’s polymerase chain reaction (PCR)-based approach to gut microbiota profiling versus DNA sequencing, competitive landscape, and opportunities for supporting pharma R&D and assessing drug treatment success.

Medical Device Diagnostics

UK’s ISRCTN Registry Makes It Easier To Track Clinical Trial Transparency

The ISRCTN clinical trials registry has launched an improved dashboard to provide metrics that reveal how many studies are complying with key transparency requirements. Badges are in place for individual studies meeting the transparency criteria.

Clinical Trials Compliance

Empowering Primary Care Physicians With Digital Biomarkers For Early Alzheimer’s Detection

Altoida CEO Mark Jones has high hopes that the company’s digital assessment tool will be approved by the FDA to be used along with blood biomarker testing by primary care doctors to help predict Alzheimer’s disease before patients show symptoms.

Digital Health Neurology
Podcasts

Digital Health Roundup: Digital Therapeutics Navigate GLP-1, Immersive Gaming; DHCoE AI Framework; Hello Heart

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.

Digital Health Roundup Behavioral Health

Digital Health Roundup: Brain Talk On Seizures, Alzheimer's, Stress, Anxiety; Medtronic's OR Report; Health Care AI; UK Guidances

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. 

Digital Health Roundup Digital Health

Medtech Connect 16: AI For Cross Border Regulation

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.

Digital Health Manufacturing

Podcast: Lung Life AI CEO Shares Regulatory And Reimbursement Journey For Lung Cancer Diagnostic

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.

See All
Recent Stories

Warning Letters – September 2024

The US Food and Drug Administration released three warning letters last month, two of which went to Chinese device testing labs accused of improper treatment of laboratory animals.

Research Finds AI Stethoscopes Detect Heart Failure Signs

The results from a trio of studies show that AI-powered digital stethoscopes are effective at identifying patients at elevated risk of experiencing heart attacks and other major cardiac adverse events, according to Eko Health, whose technology was used to screen the participants in the studies.

Modernizing Medical Device Design Control: From Waterfalls to a New Landscape

The regulatory, industrial and methodological changes applied to the medtech sector since the introduction of the US Food and Drug Administration’s design control guidance in 1997 are many and varied. Dr. Stuart Grant of Archetype MedTech looks at the challenges these changes present to both innovators and regulators and how the industry needs to adapt.

Global Medtech Guidance Tracker: September 2024

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

X-ray Regulations Detailed In New FDA Guidance

The US FDA has published final guidance to provide clarification for industry and agency staff on federal regulations of diagnostic X-ray equipment.

Genetic Analysis Leaders On Gut Microbiota Testing, Pharma Connections And Direct-To-Consumer Scene

Genetic Analysis CEO Ronny Hermansen and Christina Casén, senior VP of clinical and medical affairs, discuss the company’s polymerase chain reaction (PCR)-based approach to gut microbiota profiling versus DNA sequencing, competitive landscape, and opportunities for supporting pharma R&D and assessing drug treatment success.

UK’s ISRCTN Registry Makes It Easier To Track Clinical Trial Transparency

The ISRCTN clinical trials registry has launched an improved dashboard to provide metrics that reveal how many studies are complying with key transparency requirements. Badges are in place for individual studies meeting the transparency criteria.

FDA Opens Performance Pathway To Four Dental Device Types

Guidance documents issued 30 September explain how makers of air powered dental handpieces and air motors, dental cements, dental ceramics, and dental impression materials can bring their products to market by demonstrating compliance with established criteria, without a direct comparison to a predicate device.

EU Regulatory Round-Up, September 2024: Change Is In The Air

Those working in the medtech sector returned from their traditional August break to a growing sense that the EU is more collectively aligned about the need to improve the medtech regulations and soon.

Synchron Announces Positive Results From Stentrode BCI Study, Plans For Pivotal Study

After announcing positive results showing that its Stentrode BCI is safe in six patients, brain-computer interface company Synchron is planning a pivotal trial to eventually file for FDA approval.

Device Shortages A Matter Of National Security, Califf Says

During an online seminar hosted by the Alliance for a Stronger FDA, Commissioner Robert Califf discussed key issues facing the agency, including supply chains, device shortages, and the risk of another pandemic.

Route 92 To Drive FreeClimb Neurointervention Sales With Extended Series F Funding

An additional $50m brings the neurovascular intervention specialist’s total Series F funding to $82m. Route 92 says it will use the capital to build its sales and support teams and pursue regulatory authorizations around the globe for its FreeClimb portfolio while advancing its SUMMIT MAX clinical trial for the investigational Monopoint Reperfusion System.

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