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Expert Panel Review Likely For Just 10% To 20% Of Files Submitted

Expert panel review of clinical files for high-risk devices is happening for the first time under the new EU medtech regulations. The process has begun but expert panel opinions may be rarer than many had originally expected.

Medical Device In Vitro Diagnostics EU

FDA: Companies Servicing Products Could Get In Hot Water For Remanufacturing

A new draft guidance from the US FDA clarifies what it considers to be remanufacturing. Companies remanufacturing devices are regulated by the agency and may require new premarket applications.

Regulation Guidance Documents FDA

CMR Surgical And Microsoft Collaboration Opens Up Questions About Surgical Data Storage

In a research venture tackling problems in data storage, CMR Surgical and Microsoft have teamed up to trial Microsoft’s new silica product by storing data acquired from CMR Surgical’s Versius robotic surgery system.

Digital Health Artificial Intelligence Robotic Surgery

Digital Health Roundup, May 2021: Immersive Technologies In Surgery Suite, ‘Smart’ Toilets And Pills; New SaMD Cybersecurity Standards

In this new roundup feature focusing on the most notable developments in digital health, we pick the key news from May.

Digital Health Innovation Artificial Intelligence

Execs On The Move: Obalon Therapeutics Refreshes Board; Infab Corp Appoints New CEO

Obalon shuffles leadership as it completes merger with with ReShape Lifesciences, and Daren Dickerson, previously Infab's chief finance officer, will now manage day to day operations as chief executive officer.

Appointments Commercial Companies

Device Week, 18 June 2021 – MDUFA V Update; FDA’s Shuren Speaks; Harmonized QS Reg Almost Here?

On this week’s podcast we give an update on the Medical Device User Fee Amendments (MDUFA V) process. We also discuss US FDA device center director Jeff Shuren’s comments about pre-submission meetings and IVD submissions during a recent podcast interview with AdvaMed. Finally, we talk about the FDA’s latest scheduling of the release of its draft harmonized Quality System Regulation, due out this month.

Device Week Regulation Policy

QUOTED. 21 June 2021. Jeff Shuren.

US FDA device center director Jeff Shuren is asking whether the agency’s engagement with industry has been changed forever because of COVID-19.

Quoted Review Pathway FDA

Device Week Podcast


In This Episode:

CVRx Raises $75M In IPO To Commercialize And Develop Heart Failure Therapy

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

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Policy & Regulation Explore this Topic

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‘A New Kind Of Future’? FDA’s Shuren Questions Whether Engagement With Industry Will Change Post-Pandemic

US FDA device center director Jeff Shuren is asking whether the agency’s engagement with industry has been changed forever because of COVID-19.

FDA Review Pathway Coronavirus COVID-19

Proposal For EMA To Provide Medtech Expert Panel Structure Gains Traction

The medtech industry has long resisted having the European Medicines Agency involved in device oversight. Now an EU-level proposal is making device makers nervous.

Europe EU Medical Device

Latest From Policy & Regulation

Medtech Backs US Supreme Court Decision Upholding Affordable Care Act

Health care industry groups expressed support after the high court found that Texas and 17 other Republican-led states lacked standing to file suit because they hadn’t shown the act had directly harmed them.

Policy Legal Issues

IVDs: ‘Every Non-COVID Premarket Submission That Was Held Up Is Moving Forward’ Soon, FDA’s Shuren Vows

Jeff Shuren, director of the US FDA’s device center, promised in a podcast interview with AdvaMed that the agency’s backlog of in vitro diagnostic submissions not related to COVID-19 will begin abating “in the next few weeks.”

FDA Review Pathway

UK ABHI Perspectives On Enabling Regulation – Part 1: Regulatory Certainty Vital For Medtechs

With the UK on the cusp of a public consultation on the UKCA marking, directors at the ABHI stress the vital need for the MHRA to review all options in setting the right medtech regulatory framework.

United Kingdom Regulation

MDUFA V: FDA Proposes New Program To Engage External Experts Early – But Industry’s Skeptical

The US agency is asking medtech companies to fund a program that would bring together external experts to advise on their products early on, but industry is skeptical about the program’s ability.

Regulation Policy

Heads Of HHS, FDA Outline Biden's Budget Proposals To US Congress

US President Joe Biden’s proposed budget for fiscal 2022 allocates $133.7bn for HHS, a 23% increase for the department from fiscal 2021; the administration is also asking for $6.5bn for the FDA, an 8% increase from the agency’s current budget.

FDA Legislation

Netherland’s DEKRA Is Latest Notified Body Designated Under EU IVDR

With most IVDs needing to be compliant with the EU’s new IVD Regulation by late May 2022, many more testing bodies are urgently needed. The designation process is limping along, but a fifth organization has been named at last.

Europe EU

Quality Control & Compliance Explore this Topic

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Latest From Quality Control

Netherland’s DEKRA Is Latest Notified Body Designated Under EU IVDR

With most IVDs needing to be compliant with the EU’s new IVD Regulation by late May 2022, many more testing bodies are urgently needed. The designation process is limping along, but a fifth organization has been named at last.

Europe EU

‘War Room’ Death Knell? Edwards Lifesciences Expert Predicts Inspectional Front, Back Rooms Will Be Pandemic Victim

Medtech quality expert Rob Becker says the COVID-19 pandemic has likely changed the structure of audits and inspections forever, possibly ending the use of on-site “front rooms” where inspectors would work and “back rooms” where company employees would fulfill requests for documents and other items.

Enforcement Compliance

Polyurethane Foam Problems Nudge Philips To Recall Certain Sleep, Mechanical Ventilator Devices

Sound abatement foam used in particular bi-level positive airway pressure (BiPAP), continuous positive airway pressure (CPAP), and other mechanical ventilator devices made by Royal Philips could degrade, posing a risk to patients.

Recalls Safety

OUTLOOK 2021

Forward-looking features and special content, including Scrip 100, Medtech 100 and Generics Top 50 industry rankings

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Commercial Explore this Topic

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Analyst Insight: Unmasking The Impact Of COVID-19 On The Ultrasound Market

The ultrasound market took a big hit from the COVID-19 pandemic, but the crisis also spurred product and technological development, according to a report from Informa's Omdia Ultrasound Intelligence Service.

Analysis Diagnostic Imaging Coronavirus COVID-19

Latest From Commercial

Fractyl Adds $100M Investment To Address Root Causes Of Type 2 Diabetes

The series F financing will allow the company to expand clinical research supporting its unique duodenal mucosal resurfacing approach to treating metabolic disease at its source.

Financing Metabolic Disorders

BD Sues Beckman Coulter Over Flow Cytometry Patents

Becton Dickinson claims Beckman Coulter has been knowingly violating several patents since at least 2015.

Intellectual Property Legal Issues

MedTech Innovator Announces 2021 Competitors; 50 Start-Ups Vie For $350,000

MedTech Innovator has announced the 50 companies competing in its annual Showcase and Accelerator program, which will culminate at The Medtech Conference in September, where the winners will be awarded a $350,000 prize.

Financing Innovation

Novo Holdings Acquires BBI Group In Deal Worth Over $400M

To bolster its life sciences and diagnostics portfolios, Novo Holdings has made another major investment to acquire BBI Group.

M & A In Vitro Diagnostics

The Digital Pill: Author Sees Digital As Catch-All Solution For Health Care

In an interview with Medtech Insight, co-author of The Digital Pill, Elgar Fleisch proselytized the benefits of digital health, explaining how particular innovations could solve problems in health care.

Digital Health Consumer

Execs On The Move: Carbon Medical Technologies Appoints New CEO, And More

Stephanie Kent is now CEO of Carbon Medical Technologies and DiFusion Technologies has appointed two new board members.

Commercial Companies

Clinical R&D Explore this Topic

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Market Intel: How Augmented, Mixed And Virtual Reality Tech Unveils New Possibilities For Surgeons

Immersive technologies are becoming a reality in the OR. The second part of Medtech Insight’s series on the “Future of Surgery” introduces innovators of VR simulation tech, AR surgery platforms and AR Smart Glasses, and provides insights from world-renowned AR surgeons.    

Market Intelligence Digital Health Innovation

Latest From Research & Development

MedTech Innovator Announces 2021 Competitors; 50 Start-Ups Vie For $350,000

MedTech Innovator has announced the 50 companies competing in its annual Showcase and Accelerator program, which will culminate at The Medtech Conference in September, where the winners will be awarded a $350,000 prize.

Financing Innovation

Verily’s Study Watch Rejected By FDA As Parkinson’s Drug-Development Tool

US regulators say Verily’s Study Watch – meant to be used in Parkinson’s trials – doesn’t collect data needed to assess whether a patient is truly benefitting from a drug.

Regulation Research & Development

Cardiovascular Catch-Up: Spring Brings Bloom Of New Clinical Trial Results And Launches

April and May were full of cardiovascular professional society conferences, yielding important new research results along with announcements of major new clinical trials. Here are a few of the highlights.

Clinical Trials Cardiovascular

Device Week, 9 June 2021 – ATTD Medtronic Update; CVRx IPO

In this week’s podcast, Medtech Insight's UK-based reporter Barnaby Pickering provides an update on Medtronic’s MiniMed 780G insulin pump cost-savings study, presented at the Advances Technologies & Treatments for Diabetes (ATTD) conference. US Commercial and R&D manager, Reed Miller, highlights details on CVRx’s recent IPO.

Commercial Device Week

CVRx Raises $75M In IPO To Commercialize And Develop Heart Failure Therapy

The funds will support expanded commercialization of the company’s baroreflex activation stimulation technology to treat heart failure in patients with a low left-ventricular ejection fraction.

Financing Research & Development

US FDA Announces Trial-Focused Spinal Devices Workshop

The 17 September session will home in on the details of spinal device regulation, including adverse event reporting and efforts to increase diversity in study populations.

Regulation FDA
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