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Featured Stories

BREAKING: Shuren Steps Down As CDRH Director

The US FDA device center head is retiring after 28 years in the federal sector and 15 at the helm of CDRH. Deputy center director Michelle Tarver will step in as acting head.

FDA Leadership Regulation

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 Artificial Intelligence

EU Must Widen Debate Around Medtech Regulations Beyond Liese’s Proposal

The EU needs to conduct a deeper, more decisive analysis of its medtech regulatory problems before it decides how to adopt elements of MEP Peter Liese’s proposed amending regulation, regulatory expert Tom Melvin told Medtech Insight.

Europe EU Medical Device

Court Orders Asset Freeze For Test Strip Counterfeiters

A New York district court ordered the asset freeze after finding that the owners of H&H Wholesale Services had concealed or gambled away money owed to Abbott. The company was ordered to pay Abbott $33m in 2023 for distributing test strips authorized for sale only outside the US.

Enforcement Legal Issues Commercial

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

FDA Publishes FAQs On Final Rule Establishing Oversight Of LDTs

The US FDA has created a web page with answers to common questions concerning the agency’s final rule on regulating laboratory developed tests as medical devices.

FDA In Vitro Diagnostics

Top FDA Staff Are Pushing Review Teams To Be Comfortable With Regulatory Flexibility

Senior leadership in the FDA’s drugs, biologics and devices centers want reviewers to feel more comfortable taking risks in product approvals, but may need more concrete examples of regulatory flexibility's success to convince them.

Drug Approval Standards Rare Diseases

Inspections Of Chinese Syringe Manufacturer Prompts Additional Warnings

The US FDA has issued two new warning letters to Chinese syringe makers Jiangsu Shenli and Jiangsu Caina following inspections of their facilities. The letters are the latest in what has been an ongoing investigation into these devices.

FDA Warning Letters

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
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

News We’re Watching: Nipro Medical Invests $397.8M In First US Facility; Baxter, Hamilton Ventilator Recalls; FDA Warnings; And More

This week, Nipro Medical Corp. announced it will invest $397.8m to build a US-based production plant, generating 232 new jobs; both Baxter and Hamilton announced ventilator recalls; Imperative Care wins FDA clearance for its stroke catheter; Intelligent Ultrasound Group plc entered into a conditional sale and purchase deal to sell its Clinical AI business to GE HealthCare for £40.5m; RMI distributed 350m rapid test kits in the fight against HIV/AIDS; Jiangsu Shenli Medical Production Co., Ltd received a second FDA warning letter about quality and safety of plastic syringes.

News We're Watching Approvals

DeepWell DTx Brings Mental Health To Meta Store

Zengence, the first virtual reality game intended to help reduce stress, became available earlier this summer. We talked to DeepWell DTx founder Ryan Douglas about the road ahead.

Digital Health Commercial

Clinicians: ‘Show Me The Impact And Outcomes Of AI Tools’

Royal Philips’ ninth annual Future Health Index global report reveals a growing acceptance by clinicians and health care stakeholders of virtual care and AI-enabled innovation. These tools can address workforce shortages, financial burdens and growing demand for care, said chief innovation and strategy officer Shez Partovi.

Leadership Artificial Intelligence
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Interviews

EU Must Widen Debate Around Medtech Regulations Beyond Liese’s Proposal

The EU needs to conduct a deeper, more decisive analysis of its medtech regulatory problems before it decides how to adopt elements of MEP Peter Liese’s proposed amending regulation, regulatory expert Tom Melvin told Medtech Insight.

Europe EU

Why And How Last-Option, Essential Devices Must Now Be Identified As A Matter Of Urgency

With the axe falling on a growing number of essential legacy products, Tom Melvin explains why a plan around derogations for devices falling through the regulatory crack is now critical.

EU Europe

Sinaptica On Precision Neuromodulation To Combat Alzheimer’s: ‘No Drug Dares Go After Moderate Patients’

CEO Ken Mariash and scientific co-founder Giacomo Koch discuss plans for a Phase 3 trial in 2025 supporting Sinaptica’s combination of transcranial magnetic stimulation, electroencephalography and machine learning to slow Alzheimer’s progression. Potential synergies with anti-amyloid drugs, reflections on the US FDA’s TAP program, and insight into the company’s machine learning capabilities.

Research & Development Neurology

Quantum Surgical Plans Expansion In Asia, Additional EU, US Indications For Oncology Surgical Robot Epione

Quantum Surgical is on a mission to democratize minimally invasive cancer treatment. Its surgical robot Epione can treat inoperable abdominal and lung tumors using ablation. The company has treated over 500 patients across Europe and the US and secured €30m in funding to fuel expansion into Asia and into new cancer indications.

Europe France
Podcasts

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.

Podcast: AMR, UTI, Breathomics And 3D Printing Technology Innovators Profiled At BioWales 2024

Breathomics, UTI diagnosis and advanced wound healing innovations were among the center stage technologies at BioWales in London 2024. Hear from CEO John McKinley on Imspex Diagnostics' plans in embedded podcast.

United Kingdom Innovation

Medtech Connect Episode 15: Digital Trust

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.

Cybersecurity Digital Health
See All
Recent Stories

FDA Publishes FAQs On Final Rule Establishing Oversight Of LDTs

The US FDA has created a web page with answers to common questions concerning the agency’s final rule on regulating laboratory developed tests as medical devices.

Magenta Medical Secures $105M To Advance ‘World's Smallest Heart Pump’

Magenta Medical is preparing to launch a pivotal trial for its Elevate percutaneous Left Ventricular Assist Device, armed with $105m in new funding announced on 23 July. The company’s minimally invasive, FDA-designated Breakthrough Device supports heart function during high-risk percutaneous coronary intervention procedures.

Top FDA Staff Are Pushing Review Teams To Be Comfortable With Regulatory Flexibility

Senior leadership in the FDA’s drugs, biologics and devices centers want reviewers to feel more comfortable taking risks in product approvals, but may need more concrete examples of regulatory flexibility's success to convince them.

Inspections Of Chinese Syringe Manufacturer Prompts Additional Warnings

The US FDA has issued two new warning letters to Chinese syringe makers Jiangsu Shenli and Jiangsu Caina following inspections of their facilities. The letters are the latest in what has been an ongoing investigation into these devices.

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.

Trunzo: ’We’ve Come A Long Way To Get To Regulatory Reliance’

Medical device regulatory reliance and recognition of third-party regulators’ approvals have been making news in the UK, but in certain other markets the practice is well established. International regulatory experts explained their experiences at the MedTech Forum 2024.

Why And How Last-Option, Essential Devices Must Now Be Identified As A Matter Of Urgency

With the axe falling on a growing number of essential legacy products, Tom Melvin explains why a plan around derogations for devices falling through the regulatory crack is now critical.

News We’re Watching: Nipro Medical Invests $397.8M In First US Facility; Baxter, Hamilton Ventilator Recalls; FDA Warnings; And More

This week, Nipro Medical Corp. announced it will invest $397.8m to build a US-based production plant, generating 232 new jobs; both Baxter and Hamilton announced ventilator recalls; Imperative Care wins FDA clearance for its stroke catheter; Intelligent Ultrasound Group plc entered into a conditional sale and purchase deal to sell its Clinical AI business to GE HealthCare for £40.5m; RMI distributed 350m rapid test kits in the fight against HIV/AIDS; Jiangsu Shenli Medical Production Co., Ltd received a second FDA warning letter about quality and safety of plastic syringes.

Sinaptica On Precision Neuromodulation To Combat Alzheimer’s: ‘No Drug Dares Go After Moderate Patients’

CEO Ken Mariash and scientific co-founder Giacomo Koch discuss plans for a Phase 3 trial in 2025 supporting Sinaptica’s combination of transcranial magnetic stimulation, electroencephalography and machine learning to slow Alzheimer’s progression. Potential synergies with anti-amyloid drugs, reflections on the US FDA’s TAP program, and insight into the company’s machine learning capabilities.

MedTech Europe Appeals To Re-elected Von Der Leyen To Address MDR/IVDR Problems

Early and comprehensive reform of the MDR and IVDR is critical to address overregulation and unpredictable medtech regulatory processes, medtech tells reelected Commission President.

Quantum Surgical Plans Expansion In Asia, Additional EU, US Indications For Oncology Surgical Robot Epione

Quantum Surgical is on a mission to democratize minimally invasive cancer treatment. Its surgical robot Epione can treat inoperable abdominal and lung tumors using ablation. The company has treated over 500 patients across Europe and the US and secured €30m in funding to fuel expansion into Asia and into new cancer indications.

Q&A Guidance Doc Dives Into Combination Product User Fees

The document explains how user fees for combination products are assessed and administered, as well as waiver possibilities.

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