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Featured Stories

Medtech Connect Episode 10: Breaking Down The Transitional Coverage Of Emerging Technologies

In this episode, Medtech Insight regulatory reporter Hannah Daniel speaks to Washington Analysis vice president and senior healthcare analyst John Leppard about the Center for Medicare and Medicaid’s Transitional Coverage Of Emerging Technologies pathway, or TCET. He breaks down the pathway and discusses its pros and cons, as well as potential next steps for the agency. We also explore the history of breakthrough device coverage as well as the challenges for coverage of digital health devices.

Medicare Regulation Digital Health

Minute Insight: Stimdia Starts Trial Of Phrenic Nerve Stimulator For Patients On Ventilators

Stimdia is trying to restore respiratory function in ICU patients with phrenic nerve stimulation.

Minute Insights Clinical Trials Respiratory

New ePortal To Simplify Processing & Tracking Of WHO Prequalification Applications

The World Health Organization, whose prequalification team received over 1,000 applications last year, is launching an electronic portal that should make it easier for manufacturers and regulators to keep track of submissions.

International Government Payers Policy

Why Investing In ESG Measures Is Good For Medtech’s Health And Sustainability

For medtechs, implementing an ESG strategy will need to become a priority as global rules are being introduced for companies to report ESG data. A panel discussion with medtech ESG leaders at the recent LSX Congress USA conference in Boston outlined some strategies and sustainability goals.

Sustainability Business Strategies Manufacturing

Spotlight On Lab-Developed Test Regulation

Proposed Rule Would Apply FDA’s Diagnostic Rules To LDTs

A proposed rule from the US Food and Drug Administration would allow the agency to take on regulation of lab-developed tests by phasing out the previous approach of enforcement discretion

Policy FDA

Medtech Insight Podcasts

This Episode:

Digital Health Roundup: VR, AI Trends In Rehabilitation; Cybersecurity Regulations; Medicare Updates

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

More Podcasts

Global Device Regulation

IVD DNA Test For Cancer Receives New Regulatory Classification

The approval for Invitae’s cancer risk diagnostic test opens the door for more tests of its kind.

Regulation Cancer

Stakeholders Give FDA An Earful; Poor Communication, Recall Inefficiency, Patients At Risk

During a recent listening session on modernizing its recall process, the US FDA heard from industry, consumers, and patients — all of whom expressed a common theme: the agency needs to up its game in how it handles recalls.

FDA Policy

Global Medtech Guidance Tracker: September 2023

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 International

Warning Letters And Close-Outs – September 2023

It was a quiet month for warning letters at the FDA last month, with the agency issuing no new warning letters and closing out only one. 

Warning Letters Regulation
Digital Health

News We’re Watching: Free COVID-19 Tests, Edwards Antitrust Investigation, McKinsey Calls For Medtech ‘Reinvention’

This week, the US government relaunched a program providing free COVID-19 tests and invested $600m in domestic test manufacturing; the European Commission revealed an antitrust investigation of Edwards LifeSciences; and a consulting firm report said the medtech industry should make big changes to address investor skepticism.

Commercial Regulation

Getting Personal With Tom Miller: CEO Turned VC On Ethical Bets In Diagnostics

Medtech Insight talked to GreyBird Ventures founder Tom Miller about his investment philosophy, ethical filter in selecting diagnostics-focused start-ups, the future of diagnostics such as at-home home-testing and AI, and his life-long passion for motocross racing. 

Exec Chats Diagnostics

Postmarket Surveillance Continues To Challenge AI/ML Device Regulators

Postmarket surveillance of AI/ML is a continuing issue for regulation, DHCoE acting assistant director MiRa Jacobs says.

Artificial Intelligence Regulation

Medtech DEI Experts Talk Shop: ‘It’s Going To Transform Businesses’

An all-female panel of medtech DEI leaders at the LSX Congress USA conference discussed the importance of diversity and inclusion in research, clinical trials, product development and services to advance health equity as well as fundamental business goals.

Diversity & Inclusion Business Strategies
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Interviews

Medtech Connect Episode 10: Breaking Down The Transitional Coverage Of Emerging Technologies

In this episode, Medtech Insight regulatory reporter Hannah Daniel speaks to Washington Analysis vice president and senior healthcare analyst John Leppard about the Center for Medicare and Medicaid’s Transitional Coverage Of Emerging Technologies pathway, or TCET. He breaks down the pathway and discusses its pros and cons, as well as potential next steps for the agency. We also explore the history of breakthrough device coverage as well as the challenges for coverage of digital health devices.

Medicare Regulation

Holocare Hopes To Bring New Dimensions To Surgical Planning

The company has developed a method to convert DICOM images into 3D holograms that can be projected onto VR headsets. Medtech Insight caught up with CEO Alison Sundset to find out how Holocare is paving the way for a more integrated, collaborative form of pre-surgical planning.

Robotic Surgery Platform Technologies

Getting Personal With Tom Miller: CEO Turned VC On Ethical Bets In Diagnostics

Medtech Insight talked to GreyBird Ventures founder Tom Miller about his investment philosophy, ethical filter in selecting diagnostics-focused start-ups, the future of diagnostics such as at-home home-testing and AI, and his life-long passion for motocross racing. 

Exec Chats Diagnostics

Q&A: Allyson Mullen On ‘Uncharted Waters’ Of Breakthrough Pathway

Hyman, Phelps & McNamara partner Allyson Mullen has helped many manufacturers get breakthrough device designations from the US FDA. In this conversation, she shares her insights on the process, the best way to prepare, and why some designated devices might be slow to make it to shelves.

FDA Regulation
Podcasts

Medtech Connect Episode 9: The Intersection Of IVDs And Digital Health

In this episode, Medtech Insight regulatory reporter Hannah Daniel and managing editor Amanda Maxwell speak to Marcel Gehrung, co-founder and CEO of Cyted. Marcel discussed global regulations for Cyted’s product Endosign, and how the company leveraged the product’s flexibility to gain approval and reach markets as efficiently as possible. We also talk about different market authorization requirements in the EU, UK, and US, and the use of AI in healthcare spaces in the UK.

Digital Health Diagnostics

Digital Health Roundup: VR, AI Trends In Rehabilitation; Cybersecurity Regulations; Medicare Updates

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights VR, AI and other high tech trends in rehabilitation and gait training. Hannah Daniel discusses cybersecurity updates such as the new NIST published draft for an updated version of the Cybersecurity Framework, a recent report by Health-ISAC, and an interview with MedCrypt’s Naomi Schwartz about the upcoming FDA cybersecurity regulations for premarket approvals.

Digital Health Artificial Intelligence

Eudamed: New Dates, Constant Challenges But Light At The End Of The Tunnel

The European medical device database, Eudamed, is arguably the missing lynchpin in the implementation of the EU’s Medical Device and IVD Regulations. Medtech Insight spoke with Lionel Tussau of atrify to discover what companies need to know now and how actors should be preparing.

EU Europe

Medtech Connect Episode 8: Exploring Regulatory Differences Between The EU And US

In this episode of Medtech Connect, EU Senior Reporter Eliza Slawther and US Reporter Hannah Daniel explore the similarities and differences between EU and US regulations for digital health products in this mid-season recap episode. We talk about cybersecurity legislation, reimbursement of digital health products, and current AI regulations. If you are looking for a bird’s eye view of regulations in these two places, this is the episode for you.

Medtech Connect Digital Health
See All
Recent Stories

Medtronic Hires New Neuromodulation Leader

Paolo Di Vincenzo, the general manager of Smith+Nephew's US advanced wound management business will join Medtronic as the president of its neuromodulation business.

Executive Changes Neurology

IVD DNA Test For Cancer Receives New Regulatory Classification

The approval for Invitae’s cancer risk diagnostic test opens the door for more tests of its kind.

Regulation Cancer

Minute Insight: Medtronic May Sell Respiratory And Monitoring Units To Private Equity

Reuters reported that global private equity firm Carlyle Group has offered to pay at least $7bn for Medtronic’s patient monitoring and respiratory interventions businesses. Medtronic announced its plan to get out of those businesses about one year ago.

Minute Insights Commercial

Stakeholders Give FDA An Earful; Poor Communication, Recall Inefficiency, Patients At Risk

During a recent listening session on modernizing its recall process, the US FDA heard from industry, consumers, and patients — all of whom expressed a common theme: the agency needs to up its game in how it handles recalls.

FDA Policy

Global Medtech Guidance Tracker: September 2023

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 International

‘Build A Company To Be Bought, Not Sold,' 'Match The Asset To The Capital,' And Other Advice From VC Experts

At the recent LSX World Congress USA in Boston, Medtech Insight’s Reed Miller moderated a panel of experienced medtech investors to discuss the current medtech venture financing environment and offer advice for entrepreneurs raising money to support their innovations.

Commercial Strategies Commercial

Warning Letters And Close-Outs – September 2023

It was a quiet month for warning letters at the FDA last month, with the agency issuing no new warning letters and closing out only one. 

Warning Letters Regulation

Minute Insight: Cordis-MedAlliance Deal Formalized, Less Than One Year After Announcement

The $1.1bn acquisition of drug-eluting balloon developer MedAlliance will help Cordis return to its roots as an innovative leader in interventional cardiology.

Minute Insights Cardiovascular

Holocare Hopes To Bring New Dimensions To Surgical Planning

The company has developed a method to convert DICOM images into 3D holograms that can be projected onto VR headsets. Medtech Insight caught up with CEO Alison Sundset to find out how Holocare is paving the way for a more integrated, collaborative form of pre-surgical planning.

Robotic Surgery Platform Technologies

EU Regulatory Roundup, September 2023: Dismantling Regulatory Barriers To Medtech Innovation

The call for more to be done about the EU’s regulatory hurdles to innovation, as well as for improvements to governance, has now grown to a crescendo. While the EU looks at how best to move forward, innovation in the UK is benefiting from greater regulatory freedoms.

Europe EU

News We’re Watching: Free COVID-19 Tests, Edwards Antitrust Investigation, McKinsey Calls For Medtech ‘Reinvention’

This week, the US government relaunched a program providing free COVID-19 tests and invested $600m in domestic test manufacturing; the European Commission revealed an antitrust investigation of Edwards LifeSciences; and a consulting firm report said the medtech industry should make big changes to address investor skepticism.

Commercial Regulation

Proposed Rule Would Apply FDA’s Diagnostic Rules To LDTs

A proposed rule from the US Food and Drug Administration would allow the agency to take on regulation of lab-developed tests by phasing out the previous approach of enforcement discretion

Policy FDA
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