Investigational Device Exemption

Type: Keyphrase
Name: Investigational Device Exemption
First reported 3 hours ago - Updated 3 hours ago - 1 reports

VENITI™, Inc. Announces FDA Approval of IDE for VENITI VICI™ Venous Stent System

By a News Reporter-Staff News Editor at Clinical Trials Week -- 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 ... [Published 4 Traders - 3 hours ago]
First reported Jul 22 2014 - Updated Jul 22 2014 - 1 reports

Two-Year Trial Results Released for VertiFlex's Spinal Stenosis System

VertiFlex Inc., a developer minimally invasive interventions for spinal stenosis (inflammation of the nerves emanating from the spinal cord), has released two-year clinical results of the Superion indirect decompression system.Spinal stenosis ... [Published ODT Mag - Jul 22 2014]
First reported Jul 22 2014 - Updated Jul 22 2014 - 1 reports

Smart bandage advances patient monitoring technology

Patient monitoring technology is a growing niche within the industry, with big and small operations looking for their cut of the profits. A new device from a team of nurses, engineers and computer scientists takes the trend one step further, monitoring ... [Published FierceMedicalDevices - Jul 22 2014]
First reported Jul 18 2014 - Updated Jul 18 2014 - 1 reports

VISION Trial to Evaluate First Imaging Atherectomy Catheter to Treat Patients Suffering from Peripheral Artery Disease

— Avinger announced that John Pigott, M.D., of Jobst Vascular Institute, Toledo, Ohio, enrolled the first patient in the VISION trial, a global investigational device exemption (IDE) clinical trial approved by the U.S. Food and Drug Administration (FDA) ... [Published Diagnostic & Invasive Cardiology - Jul 18 2014]
First reported Jul 18 2014 - Updated Jul 18 2014 - 1 reports

An FDA “curriculum” helps guide medical device startups through regulatory maze

It’s  tough for medical device companies to get that stamp of FDA approval, but the labyrinthine regulatory pathway certainly doesn’t help things. Regulators want to change that:“…we learned that the delivery of new therapies to patients can be accelerated ... [Published MedCity News - Jul 18 2014]
First reported Jul 16 2014 - Updated Jul 17 2014 - 1 reports

Tucson-based SynCardia wins key FDA approval

After years of regulatory wrangling, Tucson-based SynCardia Systems Inc. has won approval from the U.S. Food and Drug Administration for a small portable driver for its temporary artificial heart.The FDA approval means the portable Freedom driver can ... [Published Arizona Daily Star - Jul 16 2014]
First reported Jul 16 2014 - Updated Jul 16 2014 - 1 reports

OncoSil Medical finalises manufacturing for pancreatic cancer device

OncoSil Medical ( ASX:OSL ) has taken a key step forward in commercialising its OncoSil™ localised radiation therapy treatment for pancreatic cancer with the revalidation of its manufacturing process.    The work with German manufacturing partner Eckert ... [Published Proactiveinvestors United Kingdom RSS feed - Jul 16 2014]
First reported Jul 16 2014 - Updated Jul 16 2014 - 1 reports

FDA approves IDE for VENITI VICI Venous Stent System

Veniti , a provider of innovative technology for the treatment of venous disease, announced has received approval from the FDA for an Investigational Device Exemption (IDE) to begin the VIRTUS trial of the VENITI VICI Venous Stent System. The VICI Venous ... [Published Center Watch - Jul 16 2014]
First reported Jul 16 2014 - Updated Jul 16 2014 - 1 reports

OncoSil Medical finalises manufacturing for pancreatic cancer device

OncoSil Medical Limited oncosil.com.auFull OncoSil Medical Limited profile hereOncoSil Medical Ltd (ASX:OSL) is developing safer and more effective ways to deliver radiation therapy to cancer patient’s tumours. The current product in development, OncoSil™, ... [Published Proactive Investors Australia - Jul 16 2014]
First reported Jul 14 2014 - Updated Jul 14 2014 - 2 reports

Veniti gets OK to start trial of new stent

Veniti, a medical device company in west St. Louis County, has received approval to start a U.S. clinical trial of its venous stent.The firm announced today that it obtained an investigational device exemption from the Food and Drug Administration. The ... [Published STLtoday.com - Jul 14 2014]
First reported Jul 10 2014 - Updated Jul 10 2014 - 2 reports

Enrolment completed in ESSENTIAL incisionless study

USGI Medical has completed enrolment for the ESSENTIAL Trial, the company’s US-based pivotal study designed to prospectively compare weight loss results between an endoscopic procedure known as POSE (Primary Obesity Surgery, Endolumenal) and a sham p ... [Published Bariatric News - Jul 10 2014]
First reported Jul 08 2014 - Updated Jul 08 2014 - 3 reports

Cesca Therapeutics Management Provides Regulatory Update On Its Proposed U.S. Pivotal Critical Limb Ischemia Clinical Trial

7/8/2014 5:54:30 AMRANCHO CORDOVA, Calif., July 8, 2014 (GLOBE NEWSWIRE) -- Cesca Therapeutics Inc. (Nasdaq:KOOL), an autologous cell-based regenerative medicine company, announced today that it recently participated in a pre-submission IDE (Investigational ... [Published BioSpace - Jul 08 2014]

Quotes

...the VFA regulatory process in Europe and have now shifted our focus to ramping our commercial activities," said Alan Milinazzo, CEO of InspireMD. "This quarter also marked the successful completion of enrollment in the CARENET trial, which we view as a significant milestone in our plans to develop the CGuard EPS for patients with carotid artery disease. Enrollment had a 100% procedural success rate and we are looking forward to sharing the results of the trial at the TCT conference in September."
...Marston. He added, "The development of stents specifically designed for the unique characteristics of the venous system provide the potential to reduce these debilitating symptoms for patients, while improving the cost effectiveness of interventional treatment for venous obstruction."
"The mobile driver unit is absolutely an important piece, because (otherwise) patients are tethered to this large machine" said Dave Fornell, editor of the Chicago-area based magazine Diagnostic and Interventional Cardiology. "This untethers them from the hospital room."

More Content

All (75) | News (60) | Reports (0) | Blogs (12) | Audio/Video (0) | Fact Sheets (0) | Press Releases (3)
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InspireMD Reports Financial Results for the Sec... [Published TickerTech.com - 2 hours ago]
VENITI™, Inc. Announces FDA Approval of IDE for... [Published 4 Traders - 3 hours ago]
Veniti Gets Green Light for Clinical Trials of ... [Published FDA News - 23 hours ago]
Two-Year Trial Results Released for VertiFlex's... [Published ODT Mag - Jul 22 2014]
Smart bandage advances patient monitoring techn... [Published FierceMedicalDevices - Jul 22 2014]
VISION Trial to Evaluate First Imaging Atherect... [Published Diagnostic & Invasive Cardiology - Jul 18 2014]
An FDA “curriculum” helps guide medical device ... [Published MedCity News - Jul 18 2014]
Tucson's SynCardia wins key FDA approval [The A... [Published BusinessWeek - Jul 17 2014]
Tucson's SynCardia wins key FDA approval [Published Arizona Daily Star - Jul 17 2014]
Tucson-based SynCardia wins key FDA approval [Published Arizona Daily Star - Jul 16 2014]
OncoSil Medical finalises manufacturing for pan... [Published Proactiveinvestors United Kingdom RSS feed - Jul 16 2014]
FDA approves IDE for VENITI VICI Venous Stent S... [Published Center Watch - Jul 16 2014]
OncoSil Medical finalises manufacturing for pan... [Published Proactive Investors Australia - Jul 16 2014]
For Avita, 'NICE' Decision In September Could B... [Published Seeking Alpha - Jul 15 2014]
Veniti gets FDA IDE approval to initiate Virtus... [Published Medical Devices Business Review - Jul 15 2014]
Avinger announces enrollment of first patient i... [Published Medical Devices Business Review - Jul 15 2014]
OncoSil Medical granted ethics approval for pan... [Published Proactiveinvestors United Kingdom RSS feed - Jul 15 2014]
OncoSil Medical granted ethics approval for pan... [Published Proactive Investors Australia - Jul 15 2014]
Veniti gets OK to start trial of new stent [Published STLtoday.com - Jul 14 2014]
VENITI™, Inc. Announces FDA Approval of IDE for... [Published PR Newswire: Policy & Public Interest - Jul 14 2014]
FDA Approves Investigational Device Exemptions ... [Published Diagnostic & Invasive Cardiology - Jul 11 2014]
Enrolment completed in ESSENTIAL incisionless s... [Published Bariatric News - Jul 10 2014]
USGI Medical fills enrollment for pivotal U.S. ... [Published FierceMedicalDevices - Jul 10 2014]
USGI® Medical Completes Enrollment in U.S. Pivo... [Published Stock Nod - Jul 09 2014]
USGI® Medical Completes Enrollment in U.S. Pivo... [Published Myrtle Beach Sun News - Jul 09 2014]
La Jolla Announces Planned Initiation Of Phase ... [Published BioMedReports - Jul 09 2014]
Cesca Therapeutics Management Provides Regulato... [Published BioSpace - Jul 08 2014]
CESCA Management Provides Regulatory Update on ... [Published GlobeNewswire: Acquisitions News - Jul 08 2014]
CESCA Management Provides Regulatory Update on ... [Published The CW44 Tampa Bay - Jul 08 2014]
CESCA Management Provides Regulatory Update on ... [Published Industrial Info Financials - Jul 08 2014]
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Blogs

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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 ...
Solace Therapeutics Receives Two FDA Clearances... [Published EON Business - Jun 18 2014]
FRAMINGHAM, Mass. FRAMINGHAM, Mass.--(EON: Enhanced Online News)--Solace Therapeutics, Inc., today announced the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Guardian Urethral Sheath and Investigational ...
Solace Therapeutics Receives Two FDA Clearances... [Published EON Consumer - Jun 18 2014]
FRAMINGHAM, Mass. FRAMINGHAM, Mass.--(EON: Enhanced Online News)--Solace Therapeutics, Inc., today announced the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Guardian Urethral Sheath and Investigational ...
Solace Therapeutics Receives Two FDA Clearances... [Published EON Science - Jun 18 2014]
FRAMINGHAM, Mass. FRAMINGHAM, Mass.--(EON: Enhanced Online News)--Solace Therapeutics, Inc., today announced the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Guardian Urethral Sheath and Investigational ...
Solace Therapeutics Receives Two FDA Clearances... [Published Business Wire Professional Services News - Jun 18 2014]
FRAMINGHAM, Mass. FRAMINGHAM, Mass.--(BUSINESS WIRE)--Solace Therapeutics, Inc., today announced the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Guardian Urethral Sheath and Investigational Device Exemption ...
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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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