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Clinical / R & D

Set Alert for Clinical R&D

RSNA 2019: AI, Machine Learning Continue To Dominate Developments In Radiology

Artificial intelligence (AI) and machine learning took center stage at this year’s Radiological Society of North America meeting in Chicago, and the pervasiveness of AI tech in new product launches was further emphasized at the RSNA’s expanded AI Showcase exhibit.

Artificial Intelligence Diagnostic Imaging Innovation

Clinical Trials

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Latest From Clinical Trials

R&D Roundup, November 2019: LimFlow Starts Pivotal Trial Of Peripheral Shunt; Conservative Coronary Treatment Matches Intervention In Trial

An overview of November’s 10 most-read Medtech Insight articles on topics related to research and development of new medical technology.

Research & Development Clinical Trials

Global Approvals Snapshot: November 2019

November’s approvals include the US FDA approval of Medtronic’s In.Pact AV paclitaxel-coated balloon, for the treatment of arteriovenous access in patients with end-stage renal disease, and a CE mark that expands the indication for Edwards’ Sapien 3 TAVR device to include patients at low-risk during surgery.

Approvals Clinical Trials

Device Week, 29 November 2019 – Top Clinical Trial News From AHA & Investment Forecast From Jefferies 2019

In this week's Medtech Insight podcast, deputy editor Reed Miller discusses clinical trial news from the annual American Heart Association (AHA) meeting, and senior reporter Catherine Longworth highlights goings-on at the Jefferies Healthcare Conference in London.

Device Week Clinical Trials
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New Technology

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Latest From Innovation

FDA Holding February Public Meeting On Using AI In Radiology

The US agency will host a two-day meeting to discuss the evolution of artificial intelligence technology used to analyze radiological images when diagnosing patients and in advising radiologists to take optimal pictures. The takeaways from the meeting will be used by the FDA to help it develop its thinking on how to regulate such technology.

Regulation Artificial Intelligence

Market Intel: After A Year Of Partnerships, Insulin Pump Manufacturers Will Face Fierce Competition In 2020

The insulin pump market is expected to grow to $5.1bn by 2023, driven by the increasing incidence of diabetes and adoption of next-generation hybrid closed-loop systems that allow patients and health-care providers to better manage care. This first part of a two-part series highlights the rising competitive landscape of the four major players, Medtronic, Insulet, Tandem Diabetes Care and Valeritas, with insights from endocrinologists. The second part will look at the smaller players, which are also gearing up to introduce new products in 2020.

Market Intelligence Diabetic Care

Tech Companies Grappling With A Brave New World Of Regulations While Developing Digital-Health Products

Software firms interested in the digital-health arena are engaging US FDA more and bolstering their regulatory credentials to navigate an unfamiliar regulatory landscape, industry experts tell Medtech Insight.

Digital Health Regulation
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Approvals

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Latest From Approvals

Global Approvals Snapshot: November 2019

November’s approvals include the US FDA approval of Medtronic’s In.Pact AV paclitaxel-coated balloon, for the treatment of arteriovenous access in patients with end-stage renal disease, and a CE mark that expands the indication for Edwards’ Sapien 3 TAVR device to include patients at low-risk during surgery.

Approvals Clinical Trials

QUOTED. 28 November 2019. Jeff Shuren.

Tusker Medical won US FDA approval for its Tubes Under Local Anesthesia (Tula) System, the first device allowing ear tubes to treat recurrent ear infections in children to be installed in the physician's office under local anesthesia. See what Jeff Shuren, director of the agency's device center, said about it here.

Quoted Approvals

Ear-Tube Insertion Moves To Physician Offices With Breakthrough Device

A device newly approved by the US FDA will allow physicians to insert ear tubes to treat recurrent ear infections in the office, eliminating the risks of general anesthesia. The Tubes Under Local Anesthesia (Tula) System was reviewed via the agency’s breakthrough device pathway.

Approvals FDA
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