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Covidien announces financial results for first quarter of fiscal 2014

Covidien plc today announced financial results for the first quarter of fiscal 2014 (October - December 2013). First-quarter net sales of $2.64 billion increased 3% from the $2.57 billion in the first quarter a year ago. Operational sales growth in the quarter was 5%, as foreign exchange rate movement lowered the quarterly sales growth rate by two percentage points.

24 Jan 2014

BIDMC receives FDA approval to use new medical device in patients with severely damaged aortic heart valves

Beth Israel Deaconess Medical Center (BIDMC) yesterday became the first institution in the United States to use a new minimally invasive medical device since it received FDA approval last week.

From Medtronic 24 Jan 2014

FDA mandates enrollment and monitoring of women in post-approval studies for medical devices

The U.S. Food and Drug Administration (FDA) mandates adequate enrollment of women in post-approval studies (PAS) of medical devices to ensure that any sex differences in device safety and effectiveness are not overlooked.

24 Jan 2014

ACM Global acquires Phoenix PCS to expand operation in the Asia Pacific region

ACM Global Central Laboratory, a diagnostic central laboratory specializing in delivering high quality testing services which optimize clinical trial outcomes, today announced it has acquired Phoenix Pharma Central Services Pte. Ltd, a premier central laboratory services provider for Asia Pacific clinical trials, with laboratory facilities in Singapore and Shanghai, China. The acquisition enables ACM Global to deliver increased operational and financial efficiencies to clients conducting clinical studies in the Asia Pacific region. Terms of the transaction were not disclosed.

23 Jan 2014

Study: CIEDs used by physicians today were approved as supplements to premarket approved models

The Food and Drug Administration (FDA) ensures that high-risk medical devices, such as implantable cardioverter-defibrillators and pacemakers, are safe and effective through its premarket approval (PMA) pathway, during which manufacturers must collect preclinical and clinical data before the device is approved.

From Medtronic 22 Jan 2014

Trendlines Labs signs deal for collaboration with Roper St. Francis Healthcare

Trendlines Labs (a unit of the Trendlines Group) recently signed an agreement for collaboration with Roper St. Francis Healthcare.

21 Jan 2014

Sigma-Aldrich and Goodfellow Cambridge join forces to distribute ceramics, metals and alloys

Sigma-Aldrich Corporation, a leading Life Science and High Technology Company, today announced the signing of an agreement with Goodfellow Cambridge, Ltd., a leading international supplier of metals and materials for research and industry, to market and distribute Goodfellow's portfolio of materials which includes metals, alloys and ceramics.

21 Jan 2014

BioLineRx gets approval to begin CE Mark registration trial of BL-5010P for skin lesion treatment

BioLineRx, a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today that it has received approval from the German Federal Institute for Drugs and Medical Devices (BfArM) to commence a pivotal, CE Mark registration trial for BL-5010P, for the non-surgical removal of benign skin lesions.

21 Jan 2014

Theravent honored with GOOD DESIGN Award for snoring therapy

Theravent, Inc., a medical device company providing noninvasive solutions for people with sleep disordered breathing, has been honored with a GOOD DESIGN Award in the medical category for the design of its product, Theravent Advanced Nightly Snore Therapy.

16 Jan 2014

Argon gets FDA clearance to market OptionELITE IVC filter over-the-wire delivery technique

Argon Medical Devices, Inc. announced today that the company has received clearance from the US Food and Drug Administration to begin marketing the OptionELITE retrievable inferior vena cava filter with a new over-the-wire delivery technique.

16 Jan 2014

Researchers develop automated venipuncture device that automates phlebotomy procedure

A new medical device has been developed that will provide phlebotomists and clinicians with a technology to enable blood drawing accuracy at first stick. This is particularly important considering the diverse patient demographic each with various levels of difficult venous access.

10 Jan 2014

Zyomyx's MyT4 point-of-care CD4 diagnostic test receives CE mark approval

Mylan, Inc. today announced that Zyomyx's MyT4 point-of-care CD4 diagnostic test has received the CE Certificate of Conformity in the European Union, an important step toward launching this innovative test and expanding access to affordable, accessible and reliable diagnostics for people living with HIV globally.

9 Jan 2014

MicroPort Scientific, Sorin Group form joint venture to market CRM devices in China

MicroPort Scientific Corporation and Sorin Group, announced today that they have entered into a definitive agreement to form a joint venture to market and develop cardiac rhythm management devices (implantable pacemakers, defibrillators, cardiac resynchronization devices and related devices) in China. MicroPort will hold a 51 percent stake in the joint venture entity, while Sorin will hold the remaining 49 percent interest.

9 Jan 2014

Bio-inspired biodegradable surgical glue repairs defects of heart and blood vessels

Gecko Biomedical, a French medical device company developing 'bio-inspired' biodegradable surgical glues and patches for wound closure, announces that the Company's co-founders have published data demonstrating the potential of its paradigm-shifting technologies for minimally invasive reconstructive heart surgery.

9 Jan 2014

Teleflex includes Vidacare vascular products in ARROW Vascular Access family

Teleflex Incorporated, a leading global provider of medical devices for critical care and surgery, will be showcasing ARROW Vascular Products along with the newly acquired Vidacare vascular product line at the annual Society of Critical Care Medicine, January 9-13 in San Francisco, California.

9 Jan 2014

Kalila Medical receives CE mark approval for Vado Steerable Introducer Sheath

Kalila Medical, a privately held medical device company focused on the development of next-generation steerable catheter technologies, today announced it has received CE mark approval for its Vado Steerable Introducer Sheath for vascular and intracardiac access including Atrial Fibrillation procedures.

8 Jan 2014

FDA completes inspection of LSNE's medical device manufacturing facility in Manchester

Lyophilization Services of New England, a New Hampshire based contract manufacturing organization is pleased to announce that the Food and Drug Administration recently completed an inspection of their Manchester manufacturing facility.

8 Jan 2014

Qardio launches revolutionary blood pressure monitor at 2014 CES show

Qardio, a technology company dedicated to transforming the way we manage our heart health and track our wellness, is formally announcing the launch of the QardioArm at the 2014 CES show. QardioArm is a revolutionary blood pressure monitor.

8 Jan 2014

A&D Medical to partner with Salutron to expand Wellness Connected platform

In a strategic business decision to provide its customers with an optimized connected health experience, A&D Medical, a global manufacturer of precision measurement solutions for the healthcare industry, announced today it will partner with Salutron, the industry leader in wearable activity monitoring technology with heart rate. With this alliance, A&D Medical will include Salutron's LifeTrak family of Bluetooth Smart activity monitors as a core component of its new Wellness Connected Platform and device suite.

8 Jan 2014

A&D Medical releases secure, flexible platform to help people manage their health

For everyone from patients to quantified selfers, A&D Medical today announced the release of its next generation Wellness Connected®, a secure, flexible platform to help people increase physical activity and manage their health.

7 Jan 2014

Medical Devices News and Research

Covidien announces financial results for first quarter of fiscal 2014

BIDMC receives FDA approval to use new medical device in patients with severely damaged aortic heart valves

FDA mandates enrollment and monitoring of women in post-approval studies for medical devices

ACM Global acquires Phoenix PCS to expand operation in the Asia Pacific region

Study: CIEDs used by physicians today were approved as supplements to premarket approved models

Trendlines Labs signs deal for collaboration with Roper St. Francis Healthcare

Sigma-Aldrich and Goodfellow Cambridge join forces to distribute ceramics, metals and alloys

BioLineRx gets approval to begin CE Mark registration trial of BL-5010P for skin lesion treatment

Theravent honored with GOOD DESIGN Award for snoring therapy

Argon gets FDA clearance to market OptionELITE IVC filter over-the-wire delivery technique

Researchers develop automated venipuncture device that automates phlebotomy procedure

Zyomyx's MyT4 point-of-care CD4 diagnostic test receives CE mark approval

MicroPort Scientific, Sorin Group form joint venture to market CRM devices in China

Bio-inspired biodegradable surgical glue repairs defects of heart and blood vessels

Teleflex includes Vidacare vascular products in ARROW Vascular Access family

Kalila Medical receives CE mark approval for Vado Steerable Introducer Sheath

FDA completes inspection of LSNE's medical device manufacturing facility in Manchester

Qardio launches revolutionary blood pressure monitor at 2014 CES show

A&D Medical to partner with Salutron to expand Wellness Connected platform

A&D Medical releases secure, flexible platform to help people manage their health

Industry Focus eBook - Medical Devices (3rd Edition) eBook

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

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