Category: Regulatory/ComplianceSyndicate content

FDA postpones orthopedic devices panel on shortwave diathermy devices

April 5, 2013 by Arezu Sarvestani

Scheduling conflicts delay the FDA's Orthopaedic & Rehabilitation Devices Panel, during which the agency was planning to discuss a possible reclassification of shortwave diathermy devices.

FDA logo

The FDA's Orthopaedic & Rehabilitation Devices Panel postponed today's meeting over scheduling conflicts that meant key players couldn't attend.

The meeting was convened to discuss a possible reclassification of shortwave diathermy devices, which are used to therapeutically heat tissue with an electric current with applications in joint inflammation treatments and physiotherapy.

Health Canada: Export equals sale of medical devices

April 5, 2013 by MassDevice

The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.

Global Medicine

By Stewart Eisenhart, Emergo Group

Health Canada official has informed Emergo Group that Canadian medical device manufacturers should consider exports of their products as sales when calculating revenues and determining Medical Device Establishment License (MDEL) fees.

InVivo Therapeutics' spinal cord scaffold wins FDA nod

April 4, 2013 by Brad Perriello

InVivo Therapeutics wins humanitarian use device status from the FDA for its biopolymer scaffold, designed to treat spinal cord injuries, clearing the way for approval of a pivotal trial.

InVivo Therapeutics

InVivo Therapeutics (OTC:NVIV) said the FDA deemed its biopolymer scaffold, designed to treat spinal cord injuries, to be a humanitarian use device.

The designation means the InVivo scaffold can seek expedited approval from the FDA for a pivotal trial of the device. HUD-based exemptions cover devices aimed at treating rare diseases and health problems, so-called "orphan" conditions.

Larger U.S. patients means larger medical devices | MassDevice.com On Call

April 4, 2013 by Arezu Sarvestani

Growing obesity in the U.S. means that medical device manufacturers, along with many other industries, must revise their products to accommodate a "larger" market.

MassDevice On Call

MASSDEVICE ON CALL — Makers of durable medical equipment have had to shift their manufacturing parameters in recent years in order to accommodate the ever-growing rates of obesity in the U.S.

It's sometimes a "heartbreaking" situation for patients, but it's also a potentially lucrative opportunity for device makers and clinicians. Clinics generally pay a premium for bigger devices, but the technology has become a medical necessity.

Diabetes: J&J recalls OneTouch Verio IQ glucose meters over failure to warn at extreme levels

April 3, 2013 by Arezu Sarvestani

Johnson & Johnson's OneTouch Verio IQ blood glucose meters were found to shut off at extremely high glucose levels, prompting a recall of all lots of the device.

Johnson & Johnson, LifeScan OneTouch Verio IQ blood glucose meters

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

FDA's new global cardiovascular registry to start with transcatheter heart valves

April 3, 2013 by Arezu Sarvestani

The FDA announces a public meeting to discuss international cooperation in monitoring and assessing cardiovascular medical devices, with an initial pilot phase to focus on transcatheter heart valves.

FDA logo

The FDA plans to launch a global cardiovascular medical device registry, with initial efforts to focus on coordinated efforts to monitor transcatheter heart valve technology.

The federal watchdog agency will host a public meeting later this month to discuss goals and strategies for organizing such an effort, which the FDA is calling the "International Consortium of Cardiovascular Registries."

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

FDA OKs Hitachi Medical CT scanner

April 3, 2013 by Brad Perriello

Hitachi Medical wins 510(k) clearance from the FDA for its scalable Scenaria Advanced 128 CT scanner

Hitachi Medical

Hitachi (NYSE:HIT) said it won 510(k) clearance from the FDA for its Scenaria Advanced 128 CT scanner, the latest in its line of scalable CT scanners.

Hitachi Medical Systems America said the latest iteration of the Scenaria Advanced includes new low-dose technology designed to reduce patients' exposure to X-ray radiation.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

Built on an AdaptiveTheme using Drupal by Michael Knapp  mknapp