Medical Devices Today

FDA Companion Dx Draft Guidance: Broad In Scope, Limited In Detail

Article preview from "The Gray Sheet"- July 18, 2011

FDA's draft guidance on the development of companion diagnostics for drug therapies, released July 12, delivers on a promise to publicly outline how it will address review of those products, but at only 12 pages, it has left some in industry longing for more insight.

Video Tech Boosts Airway Management Market

Article preview from Medtech Insight - January 1, 2011

Innovation in intubation devices, particularly video-enabled technology, is breathing new life into the market for airway management products. At the 2010 meeting of the American Society of Anesthesiologists, held in San Diego in October, manufacturers showcased a variety of new intubation devices designed to improve visualization, avoid complications, and provide fast and simple solutions for patients with difficult airways.

3WIN NV

Article preview from Start-Up - June 1, 2011

Technology originally developed for one of the most sophisticated and advanced active implantable medical devices - cochlear implants - has been key to the development of 3WIN NV's deep brain stimulation device. The Flemish start-up's neurostimulator Synapse is designed to reduce collateral stimulation through the precise delivery of an electrical charge; as well as record the neural response to better target therapy for movement disorders.

Entellus: Helping The Interventional Revolution Balloon In Sinus Therapy

Article preview from IN VIVO - June 1, 2011

The second company in the US looking to replace certain sinus surgeries with interventional procedures, Entellus is looking to further advance this technology by moving treatment from the OR to the doctor's office.

FDA Rejects Device Industry's Two-Year User Fee Plan

Article preview from "The Gray Sheet"- July 11, 2011

FDA says industry's reluctance to put a five-year user fee reauthorization plan on the table for discussion is delaying progress toward 2012 user fee legislation.

Cartilage Repair: The Next Wave in Orthopedics

Article preview from Medtech Insight - January 1, 2011

The musculoskeletal sector continues to be bogged down by the economic downturn, and particularly hard hit is the industry's largest segment: the $13 billion total joint market. Companies are now scouting out the next technology wave in orthopedics, and the record attendance at the recent International Cartilage Repair Society meeting may be one indication of where the action will be for some time to come.

In Deep Brain Stimulation, Sapiens Adopts Wise Model

Article preview from Start-Up - June 1, 2011

In early June, young company Sapiens Steering Brain Stimulation raised the largest Series A round that a device company in Europe, perhaps even in they US, has enjoyed in five years. Sapiens aims to solve several key challenges hindering deep brain stimulation: divorcing the therapeutic effect of stimulation from the unintended side effects, making the device MRI-compatible and providing physicians with an integrated image-guided procedure.

At PCR, Interventional Cardiology Looks East, Not West

Article preview from IN VIVO - June 1, 2011

For many years, the Paris Course on Revascularization, Europe's largest showcase of devices and technology used in interventional cardiology, more often looked like a mini-TCT, the US-based meeting serving interventional medicine as well. But in the last couple of years, it's been hard to miss a somewhat diminished role for US physicians. While fewer US physicians have made the trip to Paris, interventionalists from China and India have been coming to PCR in greater numbers.

Medtronic Infuse Saga Prompts Questions About FDA Approval Process

Article preview from "The Gray Sheet"- July 04,2011

Medtronic, responding last week to suggestions in the Spine Journal that financial ties to the company led researchers to hide serious adverse events associated with the firm's Infuse bone graft when writing up their studies for publication, defended itself by pointing out that the data on which FDA based its approval of the product contained no such omissions.