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Full market launch of Streamline OCT system

4/24/2014

Streamline OCT System is intended for use in the treatment of spinal stenosis, tumors, degenerative disc disease, and spondylolisthesis.

Bionic eyes? The future is here

4/24/2014

A degenerative eye disease slowly robbed Roger Pontz of his vision – but medical advancements is changing all of that.

Industry resource guides healthcare suppliers, providers

4/22/2014

GS1 Healthcare US releases implementation guideline for using GS1 standards to address FDA unique device identification (UDI).

ICDs in the MINI family

4/21/2014

Boston Scientific’s FDA approval of innovative new defibrillators and heart failure devices extends the company’s offerings.

Feeding tube with integrated camera

4/18/2014

Covidien gets U.S. Food and Drug Administration 510(k) clearance for the Kangaroo Feeding Tube with IRIS technology.

Helping med device manufacturers meet UDI compliance

4/17/2014

Kallik’s AMS360 software is proving vital for medical devices firms who need to meet critical compliance directives.

FDA clearance to market the UltraShape System

4/17/2014

Approval positions Syneron with disruptive product offering in fast growing body contouring and fat treatment market.

Device designed to replace failing aortic heart valves

4/17/2014

CoreValve system enables physicians to treat patients with aortic stenosis who are unable to undergo surgery.

510(k) clearance for the Avance MIS pedicle screw system

4/14/2014

The Avance medical device system will be in limited market release in the Q2 & Q3 of 2014, and is planned for full launch in the Q4 of 2014.

FDA clearance for Ortho Development’s Ovation Tribute hip stem

4/12/2014

Femoral hip prosthesis is intended for cementless use in total hip replacement and hemiarthroplasty procedures.

FDA clearance for Sonic Window handheld

4/12/2014

First-of-a-kind ultrasound system initially targeted for image-guided peripheral intravenous access (PIV); fits in clinicians' pocket.

Modular stand-alone cervical medical device

4/11/2014

Zimmer’s Optio-C system offers a no profile solution and delivers the strength, stability, and fusion potential of a traditional ACDF.

Expect Slimline Needle for use during endoscopic procedures

4/10/2014

Innovative handle design enables physician preferences for precision, comfort, and control when acquiring tissue samples.

Understanding the FDA’s new guidance

4/10/2014

The FDA's new device pre-submission program: What does it mean for you?

FDA health IT framework proposals, recommendations

4/8/2014

Proposed health information technology strategy aims to promote innovation, protect patients, and avoid regulatory duplication.

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