Medical Devices News and Research

RSS

Class I recall for Vital Signs HCH/Anesthesia Breathing Circuit

In April 2011, Vital Signs Devices, a GE Healthcare Company, initiated a voluntary worldwide field correction of the Vital Signs Hygroscopic Condenser Humidifier (HCH)/Anesthesia Breathing Circuit.

30 Jul 2011

FDLI conference to discuss IOM study on 510(k) Clearance Process

On the heels of the release of the highly anticipated Institute of Medicine (IOM) report, Public Health Effectiveness of the FDA 510(k) Clearance Process, The Food and Drug Law Institute (FDLI) is holding a "Dialogue" on the report August 4 in Washington, D.C.

30 Jul 2011

FDA to open docket to seek public comments on IOM's report on 510(k) program

The FDA today announced that it will open a public docket to begin receiving public comments on the Institute of Medicine's report on the 510(k) program, the most common pathway to market for lower-risk medical devices.

30 Jul 2011

FDA makes regulatory process for previously cleared 510(k) medical devices less challenging

The U.S. Food and Drug Administration today issued draft guidance that clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission.

28 Jul 2011

Wolters Kluwer announces divestment of Pharma business

Wolters Kluwer, a market leader in the professional health content and clinical decision support market, today announced a plan to divest its Pharma-related business. The company is well-positioned to benefit from healthcare reform trends globally to support the Health division's growth strategy.

27 Jul 2011

Covidien third quarter net sales increase 14% to $2.93 billion

Covidien plc today reported results for the third quarter of fiscal 2011. Net sales of $2.93 billion increased 14% from the $2.56 billion reported in the third quarter a year ago.

26 Jul 2011

Resolute drug-eluting stent superior to Taxus DES for coronary artery disease

The Resolute drug-eluting stent (DES) from Medtronic, Inc., showed superiority to Boston Scientific Corp.'s Taxus DES on the primary endpoint of the RESOLUTE Japan clinical study: in-stent late lumen loss at eight months.

26 Jul 2011

Scientists identify bacterial attack pathway

When competing for food and resources, bacteria employ elaborate strategies to keep rival cells at bay. Scientists have now identified a pathway that allows disease-causing bacteria to attack other bacterial cells by breaking down their cell wall.

22 Jul 2011

Enrollment complete in Sapheon's clinical study of saphenous vein reflux disease treatment

Sapheon Inc. announced successful enrollment in a 30-patient, prospective, single-arm clinical study of the Sapheon Closure System — a single-use, minimally invasive approach to the treatment of saphenous vein reflux disease.

22 Jul 2011

Flying is riskier than hospital says World Health Organization

According to a World Health Organization (WHO) announcement this Tuesday, millions of people die each year from medical errors and infections linked to health care and going into hospital is far riskier than flying.

21 Jul 2011

Neovasc to fund Tiara project with $4 million private placement

Neovasc Inc. today announced that it intends to complete a non-brokered private placement with accredited investors of up to four million equity units at the price of $1.00 per unit for aggregate gross proceeds of up to $4.0 million. The company expects that insiders will purchase approximately half of the units.

21 Jul 2011

RCSI introduces 30 minute magazine style surgical podcast

The Royal College of Surgeons in Ireland (RCSI) has launched 'Surgery Now', a magazine style surgical podcast which allows surgeons to easily access the latest information about clinical practice and surgical technology at the touch of a button.

21 Jul 2011

Alliqua acquires global license for wound care dressings from Noble Biomaterials

Alliqua, Inc., an advanced biomedical products company focused on the development and manufacturing of proprietary drug delivery and wound care technologies today announced that it has acquired from Noble Biomaterials, Inc. a 10 year exclusive global license for two wound care dressings, with an additional 10 year renewal option.

21 Jul 2011

Caltech, Zcube collaboration will bring painless transdermal drug delivery to patients

Zcube Srl, a research venture of the Italian pharmaceutical company Zambon, and the California Institute of Technology (Caltech) have signed an exclusive research and option agreement to develop and commercialize skin patches that contain embedded carbon nanotubes for delivering drugs. The patches will first be developed to painlessly administer drugs through the skin; other applications are envisioned for future use. Mory Gharib, Hans W. Liepmann Professor of Aeronautics and professor of bioinspired engineering, is the principal investigator at Caltech.

21 Jul 2011

FDA to monitor medical apps

The Food and Drug Administration (FDA) has stepped in to regulate the rapidly expanding field of medical applications, or apps, for smart phones and other handheld devices. With the rise of the iPhone, Android and other mobile devices has come a flood of applications designed to help people stay healthy. Industry analysts estimate there are already more than 17,000 medical applications available, ranging from calorie counters to programs that let doctors view medical scans on their phones.

20 Jul 2011

Dossia introduces innovative health management system for employees

Dossia, a leading Personal Health Record System provider, today announced the launch of the Dossia Health Manager, an innovative health management system.

20 Jul 2011

DJO Global launches Turon Modular Shoulder System

DJO Global, Inc., a global provider of medical device solutions for musculoskeletal health, vascular health and pain management, today announced the introduction of the Turon Modular Shoulder System developed by the Company's surgical division, DJO Surgical.

20 Jul 2011

ICON second quarter net revenue increases 4.2% to $233 million

ICON, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today reported its financial results for the second quarter ended June 30, 2011.

20 Jul 2011

Clinipace Worldwide selected to manage Spectranetics' cardiovascular device clinical study

Clinipace Worldwide, a global digital clinical research organization (dCRO), announced today that Spectranetics Corporation, a developer, manufacturer, marketer and distributer of single-use medical devices used in minimally invasive procedures within the cardiovascular system, has selected Clinipace to manage all aspects of a pivotal cardiovascular device clinical study that will serve as the basis for 510(k) notice submission.

20 Jul 2011

FDA seeks input on proposed oversight approach for mobile medical apps

The U.S. Food and Drug Administration today announced it is seeking input on its proposed oversight approach for certain mobile applications specific to medicine or health care called mobile medical applications that are designed for use on smartphones and other mobile computing devices.

20 Jul 2011