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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 In Vitro 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 Diabetic Care

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 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 In Vitro Diagnostics

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 M & A

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Outdated medtech IT solutions are stopping people from efficiently performing their jobs, a survey has found.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

No Pay Incentives Needed For Non-Opioid Pain Control Devices, CMS Says; Industry Disagrees

Medtech firms couldn’t convince the US Medicare agency to propose additional temporary payments under Medicare for non-opioid pain management device alternatives in its proposed rule for outpatient hospitals and ambulatory surgical centers. In response, industry advocacy group AdvaMed plans to gather more data in support of payment incentives before a mid-September deadline comes for comments on the rule.

Reimbursement Medicare Regulation

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 Europe

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

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

Ambu Settles US Defense Department False-Claims Allegations

Danish device-maker Ambu has agreed to pay $3.3m to resolve allegations of False Claims Act violations. The company is said to have made medical product in Malaysia and China for sale to the Departments of Defense and Veterans Affairs, which is forbidden under the Trade Agreements Act.

Enforcement Policy

QUOTED. 16 August 2019. Melissa Michurski.

Over the past few years, the US FDA has been pulling enforcement punches, relying more on holding face-to-face regulatory meetings than firing off warning letters. See what FDA Compliance Branch director Melissa Michurski said about the meetings here.

Quoted FDA

DEKRA Soon To Start Transfer Of Clients To MDR And Has Priority Products

The official designation of a notified body in the European Commission’s Nando database is the trigger for that notified body to begin testing. But can manufacturers expect immediate service from DEKRA?

Medical Device Europe

Industry In Favor Of UDI In Australia But Wants Time To Deplete Inventory

The medical device industry is eager to explore regulatory proposals to introduce Unique Device Identification (UDI) in Australia. However, when it comes to implementation of a system, medtech firms claim they should be given enough time to clear non-UDI-compliant products from their inventory in distribution channels.

Asia Pacific Australia

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. 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

AtriCure Adds Lariat LAA Closure System With $300M SentreHeart Acquisition

AtriCure Inc. has closed a $300m structured deal to acquire SentreHEART Inc., a privately held developer of percutaneous left atrial appendage management solutions.

Cardiovascular M & A

Execs On The Move: Foundation Medicine And OneOme Hire New Chief Officers; Insulet And Quanterix See Board Changes

Genomic profiling firm Foundation Medicine snags top Roche Genentech cancer researcher as new CSO; OneOme, a health-care tech company, hires new CEO; Insulet and Quanterix hire new directors; and more.

Appointments Commercial

QUOTED. 12 August 2019. Deepak Nath.

At this year's AACC conference, Medtech Insight caught up with Siemens Healthineers' president of laboratory diagnostics Deepak Nath. See what Healthineers' Nath said about plans for their flagship Atellica solution here.

Quoted Exec Chat

Exec Chat: Deepak Nath, President Of Siemens Healthineers' Laboratory Diagnostics, Offers An Insider's Look At AACC 2019

At this year's AACC annual conference, Medtech Insight sat down with Siemens Healthineers' president of laboratory diagnostics, Deepak Nath, to learn about plans for their flagship Atellica platform including the new Asa tablet, introduced at this year's show. 

Exec Chat Commercial

Siemens Snaps Up Corindus Vascular Robotics For $1.1Bn

Siemens Healthineers AG has signed a billion-dollar deal to merge with US firm Corindus Vascular Robotics, expanding the German company's advanced therapies business.

M & A 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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