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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 Orthopedics

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

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 Companies

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 Europe

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

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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Outdated medtech IT solutions are stopping people from efficiently performing their jobs, a survey has found.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

Set Alert for Policy

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 Brexit

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 Italy

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

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

Italian Notified Body IMQ Is Likely To Be Next In Line For Official Designation

While the push for transparency was uppermost in the mind of the European Commission when it drafted the new Medical Device Regulation, the way we are learning about new notified bodies is far from transparent.

EU Regulation

Recruitment Focus Part 3: What Is Really Driving EU Medtech Regulatory Recruitment?

Ten key take-home messages from recent interviews with recruitment expert Elena Kyria on the impact of the new medical device regulations on recruitment in the EU. This is the third and final installment of the first part of an ongoing series of articles on this topic. The second series will begin in September. 

Medical Device Europe

Pediatric Scoliosis Device Nabs HDE Approval

The US FDA has approved Zimmer Biomet’s Tether device, which is the first device of its type cleared to treat children with a form of spinal curvature. It's also the first pediatric spinal device to net Humanitarian Device Exemption approval from the agency in 15 years, the company says.

Orthopedics Approvals

Regulators Urged To Avoid ‘Conflicting’ Clinical Requirements For Drug-Device Combinations In EU

EU regulators are being urged to get their skates on and publish guidance on new clinical requirements that will kick in soon for integral drug-device combination products.

Clinical Trials Combination Products

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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Boston Scientific Closes Multibillion-Dollar BTG Deal

Boston Scientific has completed the acquisition of UK interventional medicine specialist BTG. The deal, which was announced in November last year is Boston Scientific’s biggest since its controversial 2006 acquisition of heart device maker Guidant Corp. for $27bn.

M & A Deals Commercial

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

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

Medtronic, Capital District Physicians’ Health Plan Partner To 'Gamify' Diabetes Control

Health plan members will be invited to join Medtronic’s Inner Circle patient engagement program, which applies game design to help motivate and encourage patients with diabetes to achieve monthly health-outcome goals.

Commercial Healthcare Systems

QUOTED. 19 August 2019. Michael Carrel.

AtriCure Inc. has closed a $300m structured deal to acquire SentreHEART Inc., the privately held developer of the Lariat percutaneous left atrial appendage (LAA) closure device. See what AtriCure CEO Michael Carrel said about it here.

Quoted Deals

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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