Category: Regulatory/ComplianceSyndicate content

Prostate cancer: AngioDynamics wins FDA nod for NanoKnife trial

June 20, 2013 by Sony Salzman

The FDA grants investigation device exemption to AngioDynamics for a clinical trial of its NanoKnife prostate cancer device.

Prostate cancer: AngioDynamics wins FDA nod for NanoKnife trial

AngioDynamics (NSDQ:ANGO) won a green light from the FDA for a clinical trial of its NanoKnife device for treating prostate cancer.

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FDA clears OrthoSensor's Verasense knee replacement device

June 19, 2013 by Sony Salzman

The FDA clears OrthoSensor's Verasense device, designed to help surgeons fit knee replacement implants.

FDA clears OrthoSensor's Verasense knee replacement device

The FDA handed OrthoSensor a 510(k) clearance for its Verasense knee system, designed to helps surgeons measure the proper placement and motion during total knee replacement procedures.

The Sunrise, Fla.-based device maker is touting the clearance as the 1st for a system that combines limb alignment and soft tissue-balancing features.

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ArtVentive Medical wins CE Mark for peripheral catheter

June 19, 2013 by Sony Salzman

ArtVentive Medical Group wins CE Mark approval in the European Union for its EOS peripheral vascular endoluminal occlusion device, a self-expanding catheter system.

ArtVentive Medical wins CE Mark for peripheral catheter

ArtVentive Medical Group (OTC:AVTD) announced plans to launch its EOS peripheral vascular endoluminal occlusion system in the European Union following CE Mark approval for the self-expanding catheter device.

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FDA OKs expanded trial for HeartWare's heart pump

June 17, 2013 by Brad Perriello

The FDA grants conditional approval for another arm of HeartWare International's clinical trial of its heart pump as a destination therapy.

FDA OKs expanded trial for HeartWare's heart pump

HeartWare International (NSDQ:HTWR) said the FDA granted conditional approval for an expansion of the Endurance clinical trial to evaluate the effect of closer blood pressure monitoring on neurological events.

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AdvaMed on the 510(k): Leave well enough alone

June 12, 2013 by Arezu Sarvestani

Medical device industry lobbying group AdvaMed urges the FDA to avoid making needless changes to the 510(k) medical device review pathway, particularly to the rules for when device modifications merit a new application.

FDA logo

The FDA's proposal to enhance regulatory oversight of modifications made to already-cleared devices ruffled some feathers among the medtech industry, which warned that more rigid oversight could triple the agency's work without conferring much benefit to public safety.

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EndoChoice nabs 510(k) for its Fuse colonoscopy system

June 11, 2013 by Sony Salzman

The FDA clears EndoChoice’s Fuse colonoscopy system which provides a wider range of view and may help docs catch more tumors during screening.

EndoChoice

EndoChoice got the FDA's green light for the Fuse endoscopy system, which the company says features numerous improvements over traditional endoscopy technology and will help docs catch more tumors.

The Alpharetta, Ga.-based colonoscopy device maker said its clinical trials demonstrated that Fuse only has a tumor "miss-rate" of 8%, compared with 42% with a traditional device.

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Blue Belt touts FDA win for Stride knee implant

June 11, 2013 by Sony Salzman

Blue Belt technologies lands FDA clearance for its Stride unicondylar knee implant system.

Blue Belt Technologies' NavioPFS system

Blue Belt Technologies announced another major regulatory win with FDA clearance for its Stride unicondylar knee device, designed to be paired with the company's U.S.-approved NavioPFS orthopedic implantation system.

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