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Featured Stories


Execs On The Move: Roche, Smith & Grail Focus On CEO Promotions And Appointments

Early cancer detection firm Grail Inc. fills CEO position internally. Head of care solutions moves up to CEO post at Roche Diagnostics and Smiths Medical brings on a new CEO.

Appointments Commercial Medical Device

US FDA Asks Prostate Ablation Device-Sponsors For More Clinical Safety Data To Support Clearances

Almost four years after the agency first authorized a prostate ablation device, regulators have proposed a number of requirements for clinical studies that sponsors would have to meet to comply with special controls needed for the devices to be cleared for marketing.

Regulation Guidance Documents Approvals

Exec Chat: Philips' Bert Van Meurs Discusses Innovation And Plans For Image-Guided Therapy Business Unit

This year, Bert van Meurs, chief business leader of Philips' image-guided therapy business, has led two major product launches and a new partnership with Microsoft to combine Philips' Azurion angiographic platform with Microsoft's HoloLens 2 mixed-reality (MR) technology. Medtech Insight caught up with van Meurs to learn more about Azurion, the continued role of machine learning and MR, the overall business strategy and competitive landscape.

Exec Chat Innovation Diagnostic Imaging

New Data Confirm Safety Of GT Medical’s GammaTile Therapy For Brain Tumors

GT Medical is touting results from a validation study showing its GammaTile therapy controls the regrowth of brain tumors with a low rate of adverse events.

Clinical Trials Research & Development Neurology

QUOTED. 25 June 2019. Bert van Meurs.

Bert van Meurs, chief business leader of Philips' image-guided therapy business, recently spoke with Medtech Insight about two new product launches to add to the Azurion angiographic platform and the new partnership with Microsoft's HoloLens 2 mixed realty technology, among other new developments. See what van Meurs said about it here.

Quoted Exec Chat Diagnostic Imaging

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Outdated medtech IT solutions are stopping people from efficiently performing their jobs, a survey has found.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

Executive Order Gives HHS Power To Disclose True Device, Procedure Costs To Patients

Despite industry opposition, President Trump signed a cost transparency executive order giving HHS the regulatory power to reveal to the public, health-care facilities’ costs of devices and procedures.

Reimbursement Private Payers Medicare

UK And Swiss Notified Bodies Announce Bad News For Clients

The UK is about to lose most of its medtech notified body offering, as its remaining notified bodies reveal plans to migrate certificates to the EU27 in a rescue bid, given the impact of a potential no-deal Brexit. In Switzerland, too, there has been bad news for notified body clients.

 

Europe Medical Device Policy & Regulation

Warning Letter Roundup & Recap – 25 June 2019

In the only device-related warning letter released by the US FDA this week, a maker of Baker Jejunostomy tubes and intestinal tubes used for bowel decompression was cited for quality systems violations.

Device Warning Letters FDA

Manufacturers Support CMS’ New TAVR National Coverage Decision

CMS has completed its new national Medicare Coverage with Evidence Development policy for transcatheter aortic valve replacement. The final decision memo largely maintains the recommendations from the draft version released in March, including more flexible criteria for centers establishing TAVR programs, while emphasizing the importance of the interdisciplinary heart team for decision-making about valve replacement.

Medicare Reimbursement

QUOTED. 24 June 2019. Jeff Shuren.

The US FDA officially shuttered its Alternative Summary Reporting (ASR) Program on 21 June and released to the public millions of adverse event reports received by the agency between 1999 and 2019. See what the agency's device center chief, Jeff Shuren, said about it here.

Quoted FDA

Panelists Grapple With Unclear Data At Paclitaxel Meeting

A two-day US FDA advisory committee meeting this week yielded plenty of discussion about the apparent mortality risk tied to paclitaxel-coated balloons and stents, but few definitive conclusions.

Advisory Committees Cardiology

FDA Ends Summary Reporting Program, Releases 20 Years Of Adverse Events, Vows To Make MAUDE 'User-Friendly'

The US FDA today formally shuttered its Alternative Summary Reporting (ASR) Program and released to the public millions of adverse event reports received by the agency between 1999 and 2019. The FDA also wants to make its Manufacturer and User Device Experience (MAUDE) database – where all adverse events are stored – easier to use.

FDA Safety

Veteran Political Operative Joins AdvaMed To Lobby Dems

A former Democratic congressional staffer has joined the medtech industry lobby group to shepherd efforts including the medical device tax repeal, upcoming device user-fee negotiations, and more.

Regulation Lobbying

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

Warning Letter Roundup & Recap – 25 June 2019

In the only device-related warning letter released by the US FDA this week, a maker of Baker Jejunostomy tubes and intestinal tubes used for bowel decompression was cited for quality systems violations.

Device Warning Letters FDA

FDA Ends Summary Reporting Program, Releases 20 Years Of Adverse Events, Vows To Make MAUDE 'User-Friendly'

The US FDA today formally shuttered its Alternative Summary Reporting (ASR) Program and released to the public millions of adverse event reports received by the agency between 1999 and 2019. The FDA also wants to make its Manufacturer and User Device Experience (MAUDE) database – where all adverse events are stored – easier to use.

FDA Safety

Compliance Corner: Design Creep Can Turn Your Model T Into The Batmobile, FDA Investigator Warns

Intertwining design changes and document control is vital for manufacturers – especially for those whose creeping changes to a medical device can turn it into an altogether different product that requires a new 510(k) or PMA from the US FDA. Longtime agency investigator Laureen Geniusz weighs in on what she has seen in the field and offers other nuggets of design change advice.

Compliance Corner FDA

Commercial Explore this Topic

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Device Week, 20 June 2019: ADA 2019 Key Players; Trial Results From Global Kinetics And Myriad Genetics

In this edition of Device Week, Medtech Insight's Catherine Longworth chats with Marion Webb about her upcoming Market Intelligence story based on interviews with the biggest players in the diabetes market at the recent annual American Diabetes Association meeting. And Reed Miller discusses Global Kinetics' recent data on its Personal KinetiGraph that can help identify Parkinson's patients most likely to benefit from device-assisted therapy and Myriad Genetics' POLO trial results.

Device Week Diabetic Care Clinical Trials

Zoll Zeroes In On TherOx, Acquires SSO2 Therapy

Just months after receiving USA FDA approval for its SuperSaturated Oxygen (SSO2) Therapy for heart-attack treatment, Californian company TherOx has been acquired by Zoll Medical for an undisclosed sum.

Cardiovascular Cardiology

QUOTED. 19 June 2019. Justice Greg Neeley.

A Texas man’s lawsuit against the hospital that implanted him with a recalled Medtronic spinal device can move toward trial, the Texas State Court of Appeals for the 12th District has ruled. See what Justice Greg Neeley wrote in the court's opinion.

Quoted Legal Issues

Execs On The Move: Senior Management And Board Changes At OncoCyte, Adaptive Biotechnologies

OncoCyte Corp. welcomed new clinical operations and marketing VPs; immuno-sequencing diagnostics firm Adaptive Biotechnologies elected two new directors; and more.

Appointments Commercial

QUOTED. 17 June 2019. Hiten Chawla.

At this year's American Diabetes Association meeting in San Francisco, Medtech Insight sat down with Hiten Chawla, Medtronic's VP of global marketing for its diabetes business, to learn more about their announcements and plans. See what Chawla said about it here.

Quoted Innovation

ADA Exec Chat: Hiten Chawla, Medtronic's VP Of Global Marketing Discusses Diabetes Business Plans

At this year's American Diabetes Association (ADA) meeting in San Francisco, medtech giant Medtronic made several key announcements including a collaboration with Tidepool Loop, the start of a new patient trial to develop its next-generation hybrid closed-loop system and another trial to improve its sensor technology. Medtech Insight met up with Hiten Chawla, Medtronic's VP of global marketing for its diabetes business, to learn more about these plans.

Exec Chat Innovation

Varian Grows Cancer Portfolio With Endocare & Alicon Acquisitions

Varian is expanding its cancer care solutions portfolio with two new acquisitions in the interventional oncology space. The medtech giant said it will pay $185m to buy Endocare Systems, based in Austin, Texas; and Alicon, based in Hangzhou, China.

Cancer M & A

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Medtech’s AI Pioneers – Where Are We Headed?

Artificial intelligence (AI) is quickly becoming part of our day-to-day routines, and healthcare is one area in which AI stands to make the biggest impact. But where is the technology headed? Leading figures from the medtech industry gathered at the Medical Design & Manufacturing East (MD&M East) meeting held in New York City to discuss.

Artificial Intelligence Business Strategies Innovation

Global Device Approvals Snapshot: 18-24 June 2019

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. The week of 18-24 June was very slow for approvals, with no new PMAs, panel-track PMA supplements, or de novos.

Approvals Innovation

QUOTED. 20 June 2019. Fatta Nahab.

A new study shows that Global Kinetics' Personal KinetiGraph (PKG) wearable sensor system can identify the best candidates for device-assisted therapies for Parkinson's disease including deep brain stimulation. See what Fatta Nahab, a neurologist at the University of California, San Diego, said about it here.

Quoted Clinical Trials

Global Kinetics’ Personal KinetiGraph Identifies Parkinson’s Patients Suitable For Deep Brain Stimulation

A new study shows the Personal KinetiGraph wearable monitor can help clinicians identify the Parkinson’s disease patients most likely to benefit from device-assisted therapies, including deep brain stimulation.

Neurology Clinical Trials

Global Device Approvals Snapshot: 11-17 June 2019

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker, including a PMA supplement for Agilent’s PD-L1 IHC 22C3 pharmDx companion diagnostic for Merck’s Keytruda (pembrolizumab), an anti-PD-1 drug, for patients with head and neck squamous cell carcinoma. The US FDA also approved a supplement for the Cochlear Nucleus Profile Plus Series Cochlear Implant, designed to be safe with magnetic resonance imaging.

Approvals Innovation

Myriad Foresees Important Role For Genetic Testing In Pancreatic Cancer, Breast Cancer And Beyond

The results of the POLO trial, showing a benefit of Myriad’s BRACAnalysis CDx companion diagnostic for AstraZeneca’s Lynparza (olaparib) to treat pancreatic cancer offer more support for the new guidelines from the National Comprehensive Cancer Network recommending genetic testing for all pancreatic cancer patients. Myriad also stands to benefit from the growing support for genetic testing of breast cancer patients.

ASCO In Vitro Diagnostics

Biotronik Addresses US CRM Market With Its Rivacor And Acticor Lines

The company recently launched six new implantable high-voltage cardiac rhythm management devices with the thin elliptical BIOshape to minimize the risk of skin erosion around the device pocket. Rivacor and Acticor also feature Biotronik's DX leadless atrial diagnostic technology, and MRI AutoDetect which automatically switches the device to a MR-safe mode when it enters a magnetic resonance imaging environment.

Approvals Cardiology
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