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Clinical / R & D

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Risk Reviews Needed For Targeted-Therapeutic Investigational IVDs, FDA Says

In many cases, investigational in vitro diagnostic devices used for targeted therapeutic product studies must undergo their own independent US FDA review, separate from the drug being studied, the agency warns in a draft guidance document on investigational IVDs.

In Vitro Diagnostics Clinical Trials United States
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Clinical Trials

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Latest From Clinical Trials

Starts & Stops: 2017 Finishes With Progress For Edwards, Stalled Trials For Boston Scientific

Starts & Stops is a regular feature highlighting Medtech Insight's monthly picks of noteworthy clinical trial announcements, initiations, completions, and suspensions. The list for December is headlined by announcements on Edwards' transcatheter valve technologies. Meanwhile, MValve, a company Boston Scientific has invested in, is not going forward with a planned trial of its MValve dock device with Boston Scientific's Lotus valve now that Lotus is off the market.

Clinical Trials Starts & Stops

MRI And Cardiac-Rhythm Devices: A Match Made In Medicare

A proposed coverage policy from the US Centers of Medicare and Medicaid Services would not only cover magnetic resonance imaging for patients with an implanted cardiac rhythm management device with an FDA-approved indication for MRI-compatibility, but will also cover MRI in patients with devices without that FDA labeling in certain circumstances.

United States Clinical Trials

QUOTED. Jan. 16, 2018. Kelly Londy.

Check out what Lumicell CEO Kelly Londy had to say about why the device-maker is developing its LUM system to treat prostate, colorectal, esophageal and pancreatic cancers.
Quoted Clinical Trials
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New Technology

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Latest From Innovation

US Approvals Analysis: Hits Just Keep On Coming. Can It Last?

2017 was another record year for novel device approvals in the US, with typical large numbers of cardiovascular and IVD go-aheads, along with notable successes in neurology, with noninvasive stimulation and digital-app solutions seeing success. There was also an increase in 510(k) clearances last year. Here's a look at some key FDA approvals and clearance trends from the past year, including in infographic form.

Approvals Research & Development

QUOTED. Jan. 16, 2018. Kelly Londy.

Check out what Lumicell CEO Kelly Londy had to say about why the device-maker is developing its LUM system to treat prostate, colorectal, esophageal and pancreatic cancers.
Quoted Clinical Trials

Swedish Tinnitus Patch Rings In Positive Placebo-Controlled Data

Swedish company Sensori received a ringing endorsement from results of a clinical placebo study evaluating the use of its Antinitus patch to treat tinnitus. Results from the study were published in the scientific journal The International Tinnitus Journal.

Ear Innovation
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Approvals

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Latest From Approvals

US Approvals Analysis: Hits Just Keep On Coming. Can It Last?

2017 was another record year for novel device approvals in the US, with typical large numbers of cardiovascular and IVD go-aheads, along with notable successes in neurology, with noninvasive stimulation and digital-app solutions seeing success. There was also an increase in 510(k) clearances last year. Here's a look at some key FDA approvals and clearance trends from the past year, including in infographic form.

Approvals Research & Development

STAT-Dx Seals CE-IVD Mark For POC Syndromic Testing System

STAT-Dx has sealed a CE-IVD mark for its point-of-care syndromic testing system and a respiratory panel. The firm will launch the system in Europe in the second half of 2018.

Gastrointestinal In Vitro Diagnostics

Device Debut: STS' Stent For Chronic Sinusitis Gets US Go-Ahead

The Israeli portfolio company of The Trendlines Group announced that US FDA 510(k)-cleared its composite removable sinus stent system based on results of a 30-patient trial.

Approvals Innovation
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