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Featured Stories

EMA Expert Advice Pilot Could Be ‘Vital Source Of Guidance’ For SMEs

Ten medical device manufacturers will receive scientific advice from expert panels on their product clinical development strategies under a new European Medicines Agency pilot scheme. But who will it ultimately benefit and what does the scheme entail?

Europe EU Medical Device

Contrast Agent, Liquid Biopsy Tool Or Treatment? Earli Might Deliver All Three At Once

The company has developed a technology that uses engineered DNA to reprogram cancer cells, forcing them to produce substances that could be used to help image, detect or even destroy them.

Platform Technologies Cancer Diagnostics

Philips Implements Plan To Address FDA Concerns Following Harsh Inspection Report

After a lengthy inspection of a Philips facility that manufactured several recalled breathing and ventilator devices, the US Food and Drug Administration delivered a pointed report to the company highlighting multiple risk management and quality systems issues. In response, Philips wrote to the FDA outlining steps it plans to take to fix the problems.

FDA Regulation Enforcement

Product Liability Missteps Top List Of Worst Legal Verdicts Of 2022

A recent webinar ranking last year’s best and worst legal verdicts said that product liability cases involving pelvic mesh and artificial lenses were the very worst. 

Policy Legal Issues FDA

Spotlight On Meetings

News We're Watching – 27 January

This feature compiles news briefs on a range of US regulatory and legal happenings. This week: Medtronic seeks HeartWare batteries; companies sign health equity pledge; insulin dosing app cleared; recall on field decontamination kits; and the renewal of an FDA panel. 

Regulation FDA Advisory Committees

Moves For Go Ahead For MDR Proposal To Be Discussed At European Parliament

The European Commission’s proposal to extend transition timelines for legacy devices in the context of the Medical Device Regulation is already on the move. There are still questions, however, about whether a fast-track adoption is in the best interests of the medtech sector.

EU Europe Medical Device

Expert: FTC Clinical Data Requirements A Likely Challenge For Medtech Companies

Medtech Insight spoke to Sidley Austin LLP partner Jeff Senger about the challenges companies may face navigating the FTC’s updated health products guidance.

Advertising, Marketing & Sales Clinical Trials Regulation

Medtech Insight Podcasts

 

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

Medtech Insight Tweets

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Click here to access further medical device and diagnostics news.

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

German Reimbursement Reform: Hospitals Hit Back

Architects of the major reform of secondary care reimbursement have asked for the input of hospitals just once, the DKG hospital federation complains. Meanwhile, many clinics are reportedly facing insolvency later this year.

Germany Reimbursement Policy

Researchers Suggest More Care In Using Abbott’s MitraClip

New data aggregated from over 5,000 reported adverse events suggests that patients should be aware of risks using MitraClip for TEER and operators should take more caution in handling the device.

Regulation Commercial Safety

Latest From Policy & Regulation

Class I Recall Of Datascope Cardiac Assist Devices

The US Food and Drug Administration has designated a recall of Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps from Datascope/Getinge as class I due to the potential for the pumps to shut down during use.

FDA Regulation

EU Taps Power Of AI To Beat Cancer In New Imaging Initiative

The European Commission’s newly-launched Cancer Imaging Initiative will see sophisticated digital technologies based on artificial intelligence used to speed up medical innovations as part of its wider Beating Cancer Plan.

EU Europe

MDIC Cybersecurity Benchmarking Maturity Report: An ‘Honest Reflection’ Of The Industry

In an event hosted by the Medical Device Innovation Consortium, cybersecurity experts discussed a benchmark report on the state of cybersecurity in the device industry. The director of digital health product security policy at Medtronic previewed the updated Joint Security Plan.

Regulation Market Intelligence

Notified Bodies Follow Expert Panel Opinions Under EU MDR To The Letter

A review of expert panel opinions related to high-risk medical devices shows no challenges yet by notified bodies to their findings.

Policy Regulation

Belgian Research Reveals Extent Of EU’s Digital Health Tech Reimbursement Labyrinth

Digital medical products pose challenges beyond the scope of existing evaluation frameworks for medical devices, triggering proactive responses at both a national and EU-level. A report by Belgian researchers shows just how complex the situation is.

Europe EU

J&J Subsidiary Pays $9.75M To Resolve Kickback Allegations

DePuy Synthes reportedly provided a Massachusetts surgeon with more than $100,000 in free implants and tools.

Policy Enforcement

Quality Control & Compliance Explore this Topic

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Latest From Quality Control

FTC Health Products Guidance: Not Just For Dietary Supplements Anymore

The FTC has updated its guidance on health products advertising for the first time in 25 years with an expanded version that includes devices.

Advertising, Marketing & Sales Regulation

Commission Removes Warning Signs Relating To Four EU MDR Notified Bodies

There had been handful of warning signals against well-known notified bodies designated against the MDR. Why were they there and why have they just been removed?

Europe EU

Innovation To Suffer Under Revised MDR Unless Addressed Now, Suggest MDR Proposal Responses

Damage to SMEs and innovation, overly high notified body costs and concerns over lack of surveillance for critical devices are all topics addressed among responses to the European Commission’s latest MDR proposal.

Medical Device Compliance

Commercial Explore this Topic

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Pneumowave Breathes Easier In Its Fight Against Opioid Deaths After Completing £7.5m Raise

The Glasgow-based company has completed a large series A round to further develop its technology, which can be used to help save patients’ lives in the event of opioid overdose. Medtech Insight spoke to the Scottish National Investment Bank, one of the main investors, about the deal and its altruistic view of investment.

Patient Monitoring Drug Safety Platform Technologies

Latest From Commercial

Minute Insight: Abbott Wins Expanded FDA Approval For Proclaim XR Spinal Cord Stimulator For Diabetic Peripheral Neuropathy

Abbott said a major competitive benefit of the Proclaim XR SCS system is the battery life of up to 10 years at low settings.

Minute Insights Approvals

Digital Health Roundup: CES 2023 Highlights; US FDA VR, AR Website; Bayer’s Powers Up On Radiology

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb provides highlights from the recent CES 2023 conference in Las Vegas. Reed Miller discusses Abbott’s VR partnership with the Blood Centers for America and Barnaby Pickering highlights Bayer’s jump into medtech with its buyout of Blackford Analysis.

Digital Health Artificial Intelligence

Cardio Conversations: Steven Mickelsen Discusses PFA, Electrophysiology And What It Takes To Be A Physician Inventor

In the first episode of Medtech Insight’s new podcast series focused on cardiovascular technology, editor Reed Miller talks to Steven Mickelsen, one of the founders of Farapulse and Field Medical, about pulsed field ablation, an emerging technology that is changing electrophysiology.

Cardiology Innovation

Medtech Monthly, Ep. 5: Eargo CEO Discusses OTC Hearing Aids

Listen up! In this episode of Medtech Monthly, Eargo CEO Christian Gormsen discusses the newly created OTC category for hearing aids. 

Medtech Monthly FDA

FTC Health Products Guidance: Not Just For Dietary Supplements Anymore

The FTC has updated its guidance on health products advertising for the first time in 25 years with an expanded version that includes devices.

Advertising, Marketing & Sales Regulation

CES 2023: Competition Spikes In Cuffless Blood Pressure Monitoring

In this final roundup of innovative health technologies showcased at CES 2023, Medtech Insight highlights three companies, Biobeat, Conneqt and Valencell, that are developing innovative technologies for cuffless blood pressure monitoring. Biobeat is the first company to receive US FDA clearance for a wearable to monitor blood pressure, but competition looms.

Digital Health Cardiology

Clinical R&D Explore this Topic

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Minute Insight: Abbott Rolls Out Navitor Next-Gen TAVR System To Catch Up To Medtronic And Edwards

Navitor is an upgraded version of Abbott’s Portico TAVR system with a better fabric cuff and large curved aortic “cells” to reduce the risk of injury to the native valve.

Minute Insights Approvals Clinical Trials

Latest From Research & Development

Minute Insight: Abbott Wins Expanded FDA Approval For Proclaim XR Spinal Cord Stimulator For Diabetic Peripheral Neuropathy

Abbott said a major competitive benefit of the Proclaim XR SCS system is the battery life of up to 10 years at low settings.

Minute Insights Approvals

Digital Health Roundup: CES 2023 Highlights; US FDA VR, AR Website; Bayer’s Powers Up On Radiology

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb provides highlights from the recent CES 2023 conference in Las Vegas. Reed Miller discusses Abbott’s VR partnership with the Blood Centers for America and Barnaby Pickering highlights Bayer’s jump into medtech with its buyout of Blackford Analysis.

Digital Health Artificial Intelligence

CES 2023: Competition Spikes In Cuffless Blood Pressure Monitoring

In this final roundup of innovative health technologies showcased at CES 2023, Medtech Insight highlights three companies, Biobeat, Conneqt and Valencell, that are developing innovative technologies for cuffless blood pressure monitoring. Biobeat is the first company to receive US FDA clearance for a wearable to monitor blood pressure, but competition looms.

Digital Health Cardiology

Shockwave Buys Neovasc, Hoping Reducer Angina Device Complements Coronary Lithotripsy

Shockwave, which markets lithotripsy technology to treat calcified vascular disease, will pay about $100m upfront and up to $47m more in potential milestones to buy Neovasc, the Vancouver, BC-based developer of the Reducer device to treat angina.

Business Strategies Clinical Trials

CES 2023: Tech Innovations For Simulated Heart Device Testing, Seizure Prediction, And Guiding The Visually Impaired

In this second roundup of innovative health solutions showcased at CES 2023, Medtech Insight highlights SK Biopharmaceuticals’ new wearables in development for early detection of seizures, Dassault Systèmes’ simulated 3D heart, and Lighthouse Tech’s eyewear to help the visually impaired detect obstacles.

Digital Health Innovation

JPM 2023: Boston Scientific Sees Transformational Potential In PFA, BD Sticks To '2025' Investment Strategy

The annual J.P. Morgan Healthcare Conference includes presentations from major medtech companies; Some use the conference as a platform for major announcements while some just take the opportunity to explain their 2023 outlook to investors. Here are some of the highlights from the presentations on the third day of the meeting.

Business Strategies Restructuring
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