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Class I Recall On Edwards Sapien 3 Ultra Valve System

An ongoing recall of Edwards Lifesciences’ Sapien 3 Ultra transcatheter heart valve system has been elevated to Class I, indicating the US FDA’s highest risk level.

Recalls Cardiology Regulation

Stanford Launches Trial Of NeuroPace’s Responsive Neuromodulation To Stop Overeating

The DBSLOC trial will study the feasibility of using NeuroPace’s RNS responsive neuromodulation system to stimulate the nucleus accumbens in order to stop “loss-of-control” eating in people with treatment-refractory obesity, especially those who have failed to respond adequately to gastric bypass surgery.

Clinical Trials Innovation Neurology

Sir Andrew Dillon Standing Down As Head Of England’s NICE After 20 Years

Sir Andrew Dillon is stepping down from what has been described as one of the most challenging and potentially controversial roles in British public life.

Health Technology Assessment United Kingdom Market Access

Dynamic China Moves Into The Fast Lane Of Medtech Regulatory Improvements

The Chinese medtech regulatory system was a key theme at the MedTech Summit in June, where regional specialists gave updates on registration timelines and electronic submissions, and signaled how the world’s biggest market-in-waiting is speeding up its regulatory improvements in a bid to become more open and less forbidding for overseas entrants.

China Regulation Medical Device

QUOTED. 22 August 2019. Omar Ishrak.

While Medtronic PLC's Brain Therapies business was by far the fastest-growing unit in the first quarter of fiscal 2020, sales of spine surgery products grew faster in the first quarter than they have in nine quarters. See what Medtronic's CEO Omar Ishrak said about it here.

Quoted Sales & Earnings Innovation

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Medtech IT: How To Stay Ahead As Technology Accelerates

Outdated medtech IT solutions are stopping people from efficiently performing their jobs, a survey has found. Read this whitepaper to view more survey results and discusses how tech is changing Medtech.

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Policy & Regulation Explore this Topic

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Warning Letter Roundup & Recap – 21 August 2019

A maker of in vitro diagnostics was dinged for premarket, quality systems, Medical Device Reporting and corrections & removals violations. It's just one of two device-related warning letters released by the US FDA this week.

Device Warning Letters FDA Enforcement

Cost Of Certification Under IVDR Is Going To Be Huge As Manufacturers Battle Hurdles

There has been no recent impact assessment as to how business will be affected by the text of the IVD Regulation that was finally adopted. Consultant Robyn Meurant explains how industry will be paying a high price, and why many IVD companies could go under.

United Kingdom Australia Europe

German Industry Says MDR Implementation 'Too Slow' But Negative Economic Effects Still Largely Unreported

The European Commission needs to be faster and more efficient in its implementation of the new EU Medical Device Regulation (MDR), say German manufacturers, watching the remaining months of transition time slip into single figures. A few economic operators have come clean about the pressure the MDR has brought to bear, but the suspicion is that many are choosing to keep quiet.   

EU Germany

EU To Join Countries Covered By India’s Clinical Investigation Waiver Rule

Indian regulators intend to waive their clinical investigation requirements for certain medical devices that are already approved in the EU.

Clinical Trials India

Hong Kong Poised To Speed Up Device Approvals

The Medical Device Control Office is to launch a trial program for expediting the approval of certain classes of medical devices.

Approvals Regulation

Raine To Lead UK MHRA Ahead Of Permanent Head Announcement

June Raine has agreed to lead the Medicines and Healthcare products Regulatory Agency temporarily after the agency’s incumbent chief executive steps down in September.

Regulation United Kingdom

IMQ Appointment As Fourth Notified Body Under MDR: Good News But Big Questions

There are now four notified bodies designated under the new EU Medical Device Regulation. But that is not enough, and new designations do not mean immediate testing either.

Medical Device Europe

MTI Profile: US FDA's Second-In-Command Has Her Eye On A Tech-Forward Future

As principal deputy commissioner of the FDA, Amy Abernethy is focused on developing overarching policies that affect all its product centers. But perhaps what will stand as her legacy is her work to develop a data-centered strategy to improve how the agency reviews products and ensures their long-term safety and efficacy.

Leadership FDA

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

Compliance Corner: 2 FDA Compliance Branch Heads Talk Regulatory Meetings – And What You Can Expect

US FDA Compliance Branch directors Gina Brackett and Melissa Michurski shed light on the agency's use of regulatory meetings. The FDA has been pulling enforcement punches in recent years, relying more on holding the face-to-face meetings than sending warning letters.

Compliance Corner FDA

Warning Letter Roundup & Recap – 13 August 2019

A maker of medical equipment, health-care supplies, and radiation products used for general and plastic surgery was cited for quality systems violations in the only device-related warning letter released by the US FDA this week.

Device Warning Letters FDA

EU And US Could Do More Together In Areas Of Medtech Approvals And Inspections

Will medical devices be among the next sectors to feature in the EU/US MRA? The EU has put forward suggestions on how to do device trade with the US through building regulatory co-operation.

Medical Device Europe

Commercial Explore this Topic

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Roche Diagnostics Sees Data Sourcing, AI and Partnerships As Paving The Way to Personalized Health Care, But Challenges Remain

Two Roche Diagnostics executives outlined the company's vision toward personalized health care. Machine learning, partnerships and data sourcing are key. 

Personalized Medicine Business Strategies Digital Health

QUOTED. 23 August 2019. Rod Cotton.

Roche Diagnostics Corp. is moving closer to realizing its vision of personalized health care through partnerships and applying machine learning and data sourcing. See what Rod Cotton, Roche Diagnostics' senior VP of commercial operations, said about it here.

Quoted Personalized Medicine

Brain Therapies Leads Medtronic’s Growth In First Quarter Of Fiscal 2020

The medtech giant reported revenue of $7.5bn in the quarter that ended on 26 July, up 3.5% year-over-year basis, led by 12.5% growth in revenues from emerging markets. Medtronic’s fastest-growing business is its brain therapies unit, which reported 11.4% growth in the quarter.

Sales & Earnings Innovation

Execs On The Move: Operating And Science Appointments At Accelerate And BioTelemetry; Leadership Change At Revenio

In vitro testing company Accelerate Diagnostics fills COO slot; remote medical technology firm BioTelemetry appoints a CMO; a new chief executive is in place at medical measuring instruments-maker Revenio Group; and more.

Appointments Commercial

QUOTED. 21 August 2019. David Smith.

The largest diagnostics companies, including Roche Diagnostics Corp., showcased their latest products at the recent American Association for Clinical Chemistry's (AACC) conference in Anaheim. See what David Smith, regional business manager for Roche's Navify decision-support portfolio, said about it here.

Quoted Market Intelligence

QUOTED. 20 August 2019. Suzanne Winter.

Medtronic and the nonprofit health plan Capital District Physicians' Health Plan Inc. (CDPHP) announced they'll be collaborating on an outcomes-based agreement for diabetes patients using Medtronic's insulin pumps. See what Suzanne Winter, VP of Medtronic's Diabetes Group said about it here.

Quoted Healthcare Systems

Market Intel: AACC 2019 – Roundup Of The Top 5 Diagnostics Companies

The recent AACC annual meeting drew more than 20,000 laboratory professionals to the Anaheim Convention Center. Medtech Insight caught up with the leading companies in the diagnostics space for a roundup of their latest product offerings and new developments. 

Market Intelligence Diagnostics

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

FDA Approves CVRx’s Barostim Neo For Heart Failure On Expedited Pathway

The PMA approval is based on the results of the BeAT HF trial, which showed that baroflex activation therapy with Barostim Neo safely improves quality-of-life scores and exercise capacity in patients with heart failure and reduced ejection fraction.

Approvals Clinical Trials Research & Development

FDA Expands TAVR Indication To Low-Risk Patients

As expected, the US FDA has expanded the approved indication for four transcatheter aortic valves – Edwards Lifescience’s Sapien 3 and Sapien 3 Ultra, and Medtronic’s CoreValve Evolut R and CoreValve Evolut PRO – to include patients at low risk for complications during surgery.

Approvals Clinical Trials

SENSE Results Support Biotronik’s DX System For Atrial Sensing Without An Atrial Lead

Results of the SENSE trial showed Biotronik’s DX system, which is available in both ICD and CRT-D devices, can detect atrial high-rate episodes as effectively as dual-chamber ICDs and better than single-chamber ICDs even though it does not have an atrial sensing lead.

Clinical Trials Research & Development

Device Week, 15 August 2019 – AACC Recap; MDisrupt Helps Investors Navigate Medtech

In this edition of Device Week, Medtech Insight managing editor Marion Webb reports on her discussions with diagnostic company executives at the recent American Association for Clinical Chemistry meeting in Anaheim. And senior reporter Catherine Longworth previews her feature on MDisrupt, a new company that touts itself as the world’s first medical diligence company for the healthcare industry.

Device Week Research & Development

QUOTED. 7 August 2019. Andrew Newland.

UK-based liquid biopsy company Angle PLC is expecting to make a landmark regulatory submission to the US Food and Drug Administration early in the fourth quarter of 2019 for Parsortix, which aims to detect and capture circulating tumor cells in cancer patients. See what Angle's CEO, Andrew Newland, said about it here.

Quoted Clinical Trials

Assessing The Future Of Robotics In Medtech

Andy Kach, a principal in ZS's Medical Products and Services practice, offers his perspective on the “war of the robots” in the surgical technology market. He argues that companies that focus on specialized, expensive technologies will eventually cede market share to systems that are multifunctional, portable, and valuable to multiple surgical departments.

Analysis Innovation

Global Approvals Snapshot July 2019

An overview of the global medical device approvals in July, as captured by Medtech Insight's Approvals Tracker.

Approvals Innovation
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