Investigational Device Exemption

Type: Keyphrase
Name: Investigational Device Exemption
First reported Sep 19 2014 - Updated Sep 19 2014 - 1 reports

Update: Abiomed Announced Clinical Trial Results For Impella RP

Summary Abiomed announced RECOVER RIGHT clinical trial results for Impella RP earlier this week. In my original article I mentioned that Abiomed started enrolling patients for the RECOVER RIGHT clinical trial. The result remained promising for the ... [Published Seeking Alpha - Sep 19 2014]
First reported Sep 19 2014 - Updated Sep 19 2014 - 1 reports

St. Jude puts Portico on hold

St. Jude Medical has hit the pause button on its Portico resheathable heart valve used in transcatheter aortic valve replacement (TAVR) procedures after reports of reduced leaflet mobility.St. Jude received CE mark for its 25 mm valve in late 2013 as ... [Published Cardiovascular Business - Sep 19 2014]
First reported Sep 17 2014 - Updated Sep 17 2014 - 1 reports

BioControl Medical Crosses Important Enrollment Milestone in INOVATE-HF Study Evaluating CardioFit System in Heart Failure

— BioControl Medical announced that it has reached an important clinical trial milestone, reaching 480 randomized subjects — or 70 percent — of the planned 650 subjects with congestive heart failure (HF) in the INOVATE-HF (INcrease Of VAgal TonE in Heart ... [Published Diagnostic & Invasive Cardiology - Sep 17 2014]
First reported Sep 17 2014 - Updated Sep 17 2014 - 1 reports

Abiomed Inc. Announces Clinical Trial Results For RECOVER RIGHT; Oncolytics Reports from US Randomized Phase 2 Pancreatic Cancer Study

Below is a look at some of the headlines for companies that made news in the healthcare sector on September 16, 2014.Abiomed Inc. (Nasdaq: ABMD) , a leading provider of breakthrough heart support technologies, today announced clinical trial results from ... [Published BioMedReports - Sep 17 2014]
First reported Sep 16 2014 - Updated Sep 17 2014 - 2 reports

Clinical Trial Results For Impella RP Right Ventricular Heart Failure Trial "Recover Right" Released At TCT 2014

Abiomed Inc. (Nasdaq: ABMD[1]), a leading provider of breakthrough heart support technologies, today announced clinical trial results from RECOVER RIGHT, an Investigational Device Exemption (IDE) study of the Impella RP™ (Right Percutaneous) System. The ... [Published DailyMe.Com - Sep 17 2014]
First reported Sep 16 2014 - Updated Sep 16 2014 - 1 reports

FDA Regulatory and Compliance Monthly Recap

Key Findings in this Issue:Mobile health industry could get a boost as FDA draft guidance exempts certain medical devices, including digital health devicesFDA issues guidances, launches and expands programs to encourage medical device innovationFDA puts ... [Published JD Supra - Sep 16 2014]
First reported Sep 16 2014 - Updated Sep 16 2014 - 1 reports

CERUS : Submits Clinical Protocol to FDA for Intercept Platelets

Cerus Corp. reported that it has submitted a clinical protocol to the U.S. Food and Drug Administration to make the Intercept Blood System for platelets available under an Expanded Access Investigational Device Exemption to regions in the United States ... [Published 4 Traders - Sep 16 2014]
First reported Sep 15 2014 - Updated Sep 15 2014 - 1 reports

Claret Medical to Advance the Field of Cerebral Protection

— Claret Medical Inc. announced that it has entered into an agreement for up to $18 million in a Series B financing. The Series B round was led by Santé Ventures, a prominent healthcare-focused venture capital firm with $260 million in capital under management, ... [Published Diagnostic & Invasive Cardiology - Sep 15 2014]
First reported Sep 15 2014 - Updated Sep 15 2014 - 2 reports

Neurovascular: Covidien begins enrollment in 2 new trials

by Covidien begins enrolling patients in clinical trials for its Pipeline embolization system as well as all its endovascular stroke devices.Covidien  (NYSE: COV ) announced today that it enrolled the 1st patients in a pair of clinical trials evaluating ... [Published MassDevice - Sep 15 2014]
First reported Sep 10 2014 - Updated Sep 11 2014 - 2 reports

Cerus applies for expanded access IDE for platelet treatment system

News EditorCerus Corp. (NASDAQ:CERS) submits a clinical protocol to the FDA for approval to provide its Intercept Blood System for platelets to U.S. blood banks and hospitals in regions with outbreaks of Chikungunya and dengue. The company seeks clearance ... [Published Seeking Alpha - Sep 10 2014]
First reported Aug 28 2014 - Updated Aug 28 2014 - 3 reports

Sequent Medical initiates patient enrollment in IDE pivotal trial of WEB Aneurysm Embolization System

Sequent Medical, Inc. announced today that it has initiated patient enrollment in an Investigational Device Exemption ("IDE") pivotal trial to evaluate the safety and effectiveness of the WEB™ Aneurysm Embolization System ("WEB"). Adam Arthur, MD, Associate ... [Published News-Medical.Net - Aug 28 2014]
First reported Aug 25 2014 - Updated Aug 26 2014 - 2 reports

FDA says “fuhgeddaboudit” to its own proposed Pre-Decisional IDE process

The FDA recently issued a final guidance titled “FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations.” This guidance, initially issued in November 2011 and revised in June 2013, implements changes the Food and Drug Administration ... [Published Lexology - Aug 26 2014]

Quotes

...Michael R Minogue, Abiomed's Chairman, President and CEO, said, "The Impella RP is the first percutaneous, single vascular access pump designed for right heart support. The pump is designed to be used concurrently with other left ventricle pumps in the Impella platform, which in the future may offer physicians the option of percutaneous biventricular support for acute patients."
"Right-side heart failure carries a high risk of mortality, and historically has been difficult for physicians to treat minimally invasively. The data from this trial is encouraging, and demonstrates that the Impella RP may play a pivotal role in the treatment of RVF patients in need of hemodynamic support in the future here in the U S " said William O'Neill, M D , co-principal investigator for the RECOVER RIGHT trial and medical director of structural heart disease at Henry Ford Hos...
The FDA released an "Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data" in a bid to improve the gathering of clinical trial data on specific patient populations based on gender, race ethnicity and age...
...as possible to help address the threat of Chikungunya and dengue entering the blood supply," said Laurence Corash , Cerus' chief medical officer. "Supplies of platelet components are particularly vulnerable during infectious disease epidemics, since the limited 5-day shelf life of this blood component leaves little available time to implement post- donation donor follow-up and complicates the logistics of supplying platelets from other geographical areas."

More Content

All (91) | News (71) | Reports (0) | Blogs (16) | Audio/Video (0) | Fact Sheets (0) | Press Releases (3)
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Update: Abiomed Announced Clinical Trial Result... [Published Seeking Alpha - Sep 19 2014]
St. Jude puts Portico on hold [Published Cardiovascular Business - Sep 19 2014]
BioControl Medical Crosses Important Enrollment... [Published Diagnostic & Invasive Cardiology - Sep 17 2014]
Clinical Trial Results For Impella RP Right Ven... [Published DailyMe.Com - Sep 17 2014]
Abiomed Inc. Announces Clinical Trial Results F... [Published BioMedReports - Sep 17 2014]
FDA Regulatory and Compliance Monthly Recap [Published JD Supra - Sep 16 2014]
Clinical Trial Results for Impella RP Right Ven... [Published SPi World News - Sep 16 2014]
Covidien's Two Neurovascular Trial Enrolments o... [Published Zacks.com - Sep 16 2014]
LabCorp/ARCA biopharma GENETIC-AF Poster Presen... [Published Investor's Business Daily - Sep 16 2014]
LabCorp/ARCA biopharma GENETIC-AF Poster Presen... [Published Benzinga.com - Sep 16 2014]
CERUS : Submits Clinical Protocol to FDA for In... [Published 4 Traders - Sep 16 2014]
Claret Medical to Advance the Field of Cerebral... [Published Diagnostic & Invasive Cardiology - Sep 15 2014]
Neurovascular: Covidien begins enrollment in 2 ... [Published MassDevice - Sep 15 2014]
Covidien Announces Start of Enrollment in Two N... [Published Investor's Business Daily - Sep 15 2014]
Embolic Filter Reduces Cerebral Lesions During ... [Published General Medicine eJournal - Sep 13 2014]
Assessing three treatment modalities for kerato... [Published Ophthalmology Management - Sep 12 2014]
Thoratec Gains on Start of HeartMate III US Cli... [Published Zacks.com - Sep 11 2014]
Cerapedics files premarket approval for peptide... [Published Orthopedics Today - Sep 11 2014]
FDA Finalizes Guidance Regarding IDE Decisions ... [Published FDA Law Blog - Sep 11 2014]
QuantuMDx Unveils a Handheld DNA Analyzer That ... [Published Recode - Sep 11 2014]
Enanta Reports Initiation of ABT-493 Phase 2B; ... [Published BioMedReports - Sep 11 2014]
Cerus applies for expanded access IDE for plate... [Published Seeking Alpha - Sep 10 2014]
Data From RECOVER RIGHT Impella RP Trial to be ... [Published Scottrade - Sep 10 2014]
Cerus Submits IDE Supplement to Make INTERCEPT ... [Published Business Wire Health News - Sep 10 2014]
DARPA ElectRx program explores new neuromodulat... [Published Impact Lab - Sep 09 2014]
Tryton Medical raises $20M for side-branch sten... [Published MassDevice - Sep 08 2014]
St. Vincent's vascular surgeons invited to part... [Published Billings Gazette - Sep 07 2014]
EndoStim Files For IPO – The Next Big GERD Trea... [Published 24/7 Wall St - Sep 05 2014]
Aethlon receives IRB approval to begin human cl... [Published PharmaBiz - Sep 05 2014]
ReliantHeart Commences FDA Trial on HeartAssist... [Published PRWeb - Sep 05 2014]
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Blogs

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FDA Finalizes Guidance Regarding IDE Decisions ... [Published FDA Law Blog - Sep 11 2014]
By Jennifer D. Newberger –On August 19, 2014, FDA finalized its guidance document, “FDA Decisions for Investigational Device Exemption Clinical Investigations,” which was issued in draft in June 2013.  The final guidance is largely similar to the draft, ...
Cerus Submits IDE Supplement to Make INTERCEPT ... [Published Business Wire Health News - Sep 10 2014]
CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (NASDAQ:CERS) announced today that it has submitted a clinical protocol to the U.S. Food and Drug Administration (FDA) to make the INTERCEPT Blood System for platelets available under an Expanded Access ...
Sequent Medical Announces Initiation Of IDE Stu... [Published PR Newswire: General Business - Aug 28 2014]
ALISO VIEJO, Calif., Aug. 28, 2014 /PRNewswire/ -- Sequent Medical, Inc. announced today that it has initiated patient enrollment in an Investigational Device Exemption ("IDE") pivotal trial to evaluate the safety and effectiveness of the WEB™ Aneurysm ...
Santé Ventures leads $18 mln Series B funding i... [Published PE Hub Blog - Aug 22 2014]
Santé Ventures has led an $18 million Series B funding round in Claret Medical , a developer of products for cerebral protection during structural heart, vascular and cardiac surgery procedures. Other investors in the funding round included Lightstone ...
VENITI™, Inc. Announces FDA Approval of IDE for... [Published PR Newswire: Policy & Public Interest - Jul 14 2014]
ST. LOUIS, July 14, 2014 /PRNewswire/ -- VENITI, Inc., a company dedicated to providing innovative technology for the treatment of venous disease, announced that it has received approval from the United States Food and Drug Administration (FDA) for an ...
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Press Releases

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CESCA Management Provides Regulatory Update on ... [Published GlobeNewswire: Acquisitions News - Jul 08 2014]
Cesca Therapeutics Submits pre-IDE Information ... [Published GlobeNewswire: Advertising News - Mar 26 2014]
New Record of 161 SynCardia Total Artificial He... [Published PR Newswire - Jan 07 2014]
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