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Full market launch of Streamline OCT system


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


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


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

ICDs in the MINI family


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

Feeding tube with integrated camera


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


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


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

Device designed to replace failing aortic heart valves


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


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


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

FDA clearance for Sonic Window handheld


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


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


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

Understanding the FDA’s new guidance


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

FDA health IT framework proposals, recommendations


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

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