Medical Devices News and Research

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Non-surgical weight loss device clinical trial completes enrollment

ReShape Medical® Inc announced today that it has completed enrollment in the pivotal clinical trial for the ReShape Duo® Intragastric Balloon, one of the first non-surgical weight loss devices developed for the U.S. market.

25 Feb 2013

Next generation deep brain stimulation (DBS) therapy to be developed by Sapiens

Sapiens Steering Brain Stimulation B.V. (Sapiens), an emerging medical technology company developing brain stimulation products, today announced that it has raised €7.5 m from the Dutch investment group INKEF Capital, in a further extension of their Series A financing round. The proceeds will be used for the development of its Steering Brain Stimulation implant and procedure solutions to treat Parkinson's disease (PD) and other functional brain disorders.

25 Feb 2013

LINX magnetic device safe and effective in treating gastroesophageal reflux disease

A study published February 21st in the New England Journal of Medicine (NEJM) provides clinical evidence of the safety and effectiveness of a new magnetic medical device to treat gastroesophageal reflux disease (GERD).

24 Feb 2013

Muhammad Ali Parkinson Center in Phoenix launches new clinic

The Muhammad Ali Parkinson Center in Phoenix has launched a new clinic aimed at streamlining the process for the growing number of patients who are potential candidates for Deep Brain Stimulation.

20 Feb 2013

Allergan receives FDA approval for Natrelle 410 breast implant

The U.S. Food and Drug Administration today approved the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age. Natrelle 410 implants are manufactured by Allergan, Inc.

20 Feb 2013

Heart OMics in AGEing project receives European Commission grant

The HOMAGE (Heart OMics in AGEing) project, coordinated by the French National Institute of Health and Medical Research (INSERM), has been awarded a grant by the European Commission for a 6 year period.

20 Feb 2013

NeuroMetrix fourth quarter total revenues decrease to $1.5 million

NeuroMetrix, Inc., a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes, today reported business and financial highlights for the quarter and twelve months ended December 31, 2012.

19 Feb 2013

Otolaryngology, head and neck surgery: an interview with Thomas Cherry, Cook Medical

Cook Medical is the world’s largest privately held medical device manufacturer. The ENT division is Cook’s 10th business unit/clinical division and we are excited to meet the needs of ENT patients.

From COOK MEDICAL INC. 18 Feb 2013

New materials mimic mussel adhesive proteins for three medical applications

When it comes to sticking power under wet conditions, marine mussels are hard to beat. They can adhere to virtually all inorganic and organic surfaces, sustaining their tenacious bonds in saltwater, including turbulent tidal environments.

18 Feb 2013

Fluke Biomedical receives FDA clearance for ESA615 Electrical Safety Analyzer

The United States Food and Drug Administration (FDA) announced today it has granted the new automated, multifunctional ESA615 Electrical Safety Analyzer 510(k) clearance.

14 Feb 2013

FDA grants IDE approval to STS and ACC to study alternative access approaches for TAVR

The Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC) have received a unique investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to study "alternative access" approaches for transcatheter aortic valve replacement (TAVR) using the STS/ACC TVT Registry.

14 Feb 2013

HealthSaaS, iMPak announce white labeling agreement for their Connected Outcomes Platform

iMPak Health, a subsidiary of Meridian Health, today announced a white labeling agreement with HealthSaaS for their Connected Outcomes Platform. This agreement will enhance iMPak's device offerings by bringing patient data into the clinical workflow as an asset while reducing manual data entry and providing actionable information to healthcare providers.

13 Feb 2013

LSR grades for medical device manufacturers and fabricators debuted by Dow Corning at MD&M West

Dow Corning, a global leader in silicones, silicon-based technology and innovation for the healthcare industry, is showcasing at MD&M West (Hall D, Booth# 1751) Dow Corning® QP1 liquid silicone rubber (LSR) grades that give medical device manufacturers and fabricators broader material choices for intricate devices and components.

13 Feb 2013

Underwriters Laboratories announces new non-clinical lab, resources and capabilities for biocompatibility in North America

UL (Underwriters Laboratories), a world leader in advancing safety, announced today the expansion of the South Bend, Indiana analytical laboratory to offer non-clinical testing services for the medical device industry.

13 Feb 2013

STD Med, Pavilion announce joint investment to launch Saphena Medical

Pavilion Medical Innovations L.L.C. of Norwell, MA and STD Med, Inc. of Stoughton, MA are pleased to announce a joint investment to launch Saphena Medical, Inc., a new cutting edge medical device company focused on Endoscopic Vein Harvesting technologies.

12 Feb 2013

Pmt transport system helps develop new type of drug against S. aureus infection

National Institutes of Health (NIH) scientists have identified a promising lead for developing a new type of drug to treat infection caused by Staphylococcus aureus, a bacterium that frequently resists traditional antibiotics.

11 Feb 2013

Shanshi, Tensys Medical enter commercial agreement to distribute T-Line technology

Tensys Medical, Inc., a leader in the development and commercialization of continuous, non-invasive hemodynamic patient monitoring systems, has entered into a commercial agreement with Zhejiang Shanshi Medical Device CO., LTD (Shanshi) for distribution of the company's T-Line technology.

11 Feb 2013

DW Healthcare Partners completes fundraising for third fund

DW Healthcare Partners, a healthcare-focused private equity firm, announced today that it has completed fundraising for its third fund, which has closed with $265 million of committed capital, exceeding its original target of $250 million.

11 Feb 2013

Bipartisan duo introduces Medicare 'doc fix' bill in House

The effort, by Reps. Schwartz and Heck, would change the system known as the sustainable growth rate for Medicare physician payments.

10 Feb 2013

HHS turns down Miss. Insurance Commissioner's bid for exchange

Commissioner Mike Chaney wanted to set up a state-based marketplace for insurance to open next year as part of the health overhaul, but federal officials said the Mississippi governor's opposition made it impossible for the exchange to function as required by law.

10 Feb 2013