Medical Devices Today

St. Jude To Acquire CardioMEMS As FDA Approves Heart Failure Monitor

Article preview from “The Gray Sheet”- May 28, 2014

 FDA approved the CardioMEMS HF wireless heart-failure monitor, and St. Jude has exercised itsoption to buy the technology and its manufacturer. The approval is based on the results of the CHAMPION pivotal trial, which showed that patients monitored with the remote, implantable system needed fewer hospitalizations.

 

FDA Office Of Device Evaluation: People, Products On The Move

Article preview from “The Gray Sheet”- May 19, 2014

With a recent reorganization and user-fee-program ramp-up, there is a lot of hiring and promotion activity at ODE, and also some occasional head scratching about a device’s appropriate review-branch home, according to Christy Foreman, who directs the office that serves as a U.S.-market gatekeeper for many medical devices.

K2M Funds Its Focus On The Complex Spine With IPO

Article preview from “The Gray Sheet”- May 15, 2014

The 10-year-old spine firm initiated its initial public offering this month, transforming from the largest private spine device firm to another public player in a highly competitive market. CEO Eric Major K2M’s focus on complex spinal deformities will help distinguish it from the pack.

FDA Catches Heat For Plans To Raise Standards For Hospital Glucose Meters

Article preview from “The Gray Sheet”- May 6, 2014

An FDA draft guidance issued earlier this year on hospital glucose meters has attracted an unusual amount of attention, including criticism from clinicians, companies and others who worry it could cut off access to point-of-care glucose testing in patient cases where it is needed. The agency says it is taking appropriate measures to address a safety issue, and that some of the criticism is misdirected.

 

Efforts Accelerate To Add Unique Device IDs To Insurance Claims

Article preview from "The Gray Sheet"- April 10, 2014

Groups are mobilizing now to ensure that UDIs for high risk implantable devices are incorporated into claims, although it will likely be several years at least before that becomes a reality. The goal is to facilitate better data collection and more effective product recalls.

Medicare Dx Payment System Will Be Market-Based, More Transparent Under New Law

Article preview from "The Gray Sheet"- April 3, 2014

A new law makes vast changes to how clinical laboratory tests will be reimbursed by Medicare over the long term. Although the changes ultimately may lead to payment reductions, both test kits makers and laboratories applaud the new provisions. Reimbursement will better reflect the value that lab tests bring to the health care system, they say.

What Makes A Device Class III? FDA Proposes New Language To Clarify

Article preview from "The Gray Sheet"- March 24, 2014

FDA issued a proposed rule that introduces five newly defined categories that describe situations for devices when a class III designation, requiring a PMA and other heightened standards, will always be necessary.

 

Benvenue Medical Touts Next-Generation Treatment For Vertebral Compression Fractures

Article preview from Medtech Insight Newsletter - October 28, 2013

At the recent CIRCE meeting, researchers presented positive clinical data comparing Benvenue Medical Inc.’s Kiva vertebral compression fracture system versus Medtronic’s market-leading Kyphon kyphoplasty system, providing a boost for Benvenue, which is awaiting FDA 510(k) clearance of its device.

Device Firms See No Correlation Between Series A And Exit

Article preview from Start-Up - December 9, 2013

Large or small, Series A rounds in the device sector don’t have a statistical correlation with exit value, but there is some evidence that initial runway has some influence.

SYMPLICITY Results Make Life Difficult For Renal Denervation Programs

Article preview from IN VIVO - January 24, 2014

The big slice of the device industry, from large-cap firms to venture capitalists, with some stake in the renal denervation opportunity are trying to understand the new reality now that Medtronic’s pivotal Symplicity renal denervation device trial missed its endpoint.