Medical Devices News and Research

RSS

Nevro obtains new expanded MR-conditional labeling for Senza SCS system

5 Feb 2015

Clinical trial results of drug-eluting stent for peripheral arterial disease presented at LINC 2015

Historic five-year results from the world’s largest clinical trial of a drug-eluting stent for treating peripheral arterial disease (PAD) were presented last week at the Leipzig Interventional Course, in Germany. The data confirm long-term patency for patients treated with Zilver® PTX®.

From COOK MEDICAL INC. 4 Feb 2015

Trust for America's Health supports President's proposal to end sequestration

The following is a statement from Jeffrey Levi, PhD, executive director of the Trust for America's Health (TFAH) and chair of the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health.

4 Feb 2015

PPDC awards grants to three companies developing new medical devices for children

The Philadelphia Pediatric Medical Device Consortium announces its first three awards to companies developing new medical devices for children.

4 Feb 2015

RTI-HS, FDA partner to study patients' preferences that contributed to approval of new obesity device

RTI Health Solutions, a business unit of RTI International, partnered with the U.S. Food and Drug Administration to conduct a study on patients' preferences which contributed to the Agency's regulatory decision to approve the Maestro Rechargeable System, a first-of-kind device to treat obesity.

2 Feb 2015

SynTheAll Pharmaceutical wins 2015 CMO Leadership Award

WuXi PharmaTech (Cayman) Inc., a leading open-access R&D capability and technology platform company serving the pharmaceutical, biotechnology, and medical device industries with operations in China and the United States, announced today that SynTheAll Pharmaceutical Co., Ltd., WuXi's small-molecule manufacturing subsidiary, has won a 2015 CMO Leadership Award, which is presented by Life Science Leader magazine based on research conducted by Nice Insight.

30 Jan 2015

UofL study investigates safety, effectiveness of EBV for treating emphysema symptoms

The University of Louisville has launched a research trial to study an investigational medical device designed to aid patients with emphysema by shutting off the diseased part of the lung. UofL is the only site in Kentucky among 14 nationwide testing the device.

28 Jan 2015

Bronchial thermoplasty for severe asthma: an interview with Dr. Rob Niven

Internationally, severe asthma is defined as anybody who is on maximum therapy, which has no measurable side effects, but still have symptoms of persistent asthma. In the UK, that effectively means people who require oral steroids for their asthma two or more times a year.

27 Jan 2015

genae announces acquisition of e-novex

genae, a global Contract Research Organization and services provider for the medical industries, announced today the acquisition of e-novex, a leading provider of electronic data tools that change medical research.

27 Jan 2015

Neuromod Devices, Irish Tinnitus Association announce launch of Tinnitus Awareness Week 2015

Saturday 31st of January sees the launch of Tinnitus Awareness Week. This year a public event will take place, hosted by The Neuromod Clinic in conjunction with the Irish Tinnitus Association. This free of charge event will take place at The Hermitage Medical Clinic, Lucan, Dublin at 10.30am on Saturday the 31st January.

27 Jan 2015

Nevro gets FDA approval letter for Senza spinal cord stimulation system

Nevro Corp., a medical device company that has developed and commercialized an innovative, evidence-based neuromodulation platform for the treatment of chronic pain, today announced that it has received a letter from the U.S. Food and Drug Administration informing the company of the approvability of its Premarket Approval Application (PMA) for the Senza spinal cord stimulation (SCS) system.

23 Jan 2015

Gastroenterology publishes landmark data from RESPECT study of Transoral Incisionless Fundoplication procedure

EndoGastric Solutions announces that Gastroenterology, the official journal of the American Gastroenterological Association Institute and the most prominent journal in the field of gastrointestinal disease, has published landmark data from the first-ever blinded, randomized, sham- and placebo-controlled clinical study of the Transoral Incisionless Fundoplication (TIF) procedure.

22 Jan 2015

K2M obtains FDA approval to market MESA 2 Deformity Spinal System

K2M Group Holdings, Inc., a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies, techniques and minimally invasive procedures, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration to market the MESA 2 Deformity Spinal System.

22 Jan 2015

Clarkston Consulting releases 2015 Life Sciences Trends Report

Clarkston Consulting, a management and technology consulting firm specializing in the life sciences and consumer products industries, just released their 2015 Life Sciences Trends Report.

21 Jan 2015

Echo Therapeutics re-establishes operational and strategic partnership with MTIA

Echo Therapeutics, Inc., a medical device company focused on skin permeation, continuous glucose monitoring, and associated technologies, announced today that it has re-established its operational and strategic partnership with Medical Technologies Innovation Asia, Ltd., Hong Kong, and has initiated the technology transfer process.

21 Jan 2015

Johnson & Johnson announces sales of $18.3 billion for Q4 2014

Johnson & Johnson today announced sales of $18.3 billion for the fourth quarter of 2014, a decrease of 0.6% as compared to the fourth quarter of 2013. Operational results increased 3.9% and the negative impact of currency was 4.5%. Domestic sales increased 7.4%.

20 Jan 2015

Gecko Biomedical obtains 1.3 million euros to advance Bio-inspired Surgical Solutions

Gecko Biomedical, a French medical device company developing 'bio-inspired' biodegradable surgical glues and patches for wound closure, announces today it has received 1.3 million euros from Bpifrance to advance its Bio-inspired Surgical Solutions.

20 Jan 2015

First medical device approved for treatment of obesity

The United States Food and Drug Administration approved EnteroMedic's VBLOC vagal blocking therapy, delivered via the Maestro System, which is the first medical device approved for obesity treatment that targets the nerve pathway between the brain and the stomach.

15 Jan 2015

Signostics gets FDA 510k clearance for handheld bladder scanner

Medical device company, Signostics, announced today it has clearance from the U.S. Food and Drug Administration to launch the SignosRT Bladder, the company’s new hand-held bladder scanner.

15 Jan 2015

YODA Project announces availability of clinical trial data for medical devices

The Yale University Open Data Access (YODA) Project is announcing the first-ever broad availability of clinical trial data for medical devices and diagnostics by a company. This historic expansion of data sharing is made possible through collaboration with Johnson & Johnson.

15 Jan 2015

Medical Devices News and Research

Nevro obtains new expanded MR-conditional labeling for Senza SCS system

Clinical trial results of drug-eluting stent for peripheral arterial disease presented at LINC 2015

Trust for America's Health supports President's proposal to end sequestration

PPDC awards grants to three companies developing new medical devices for children

RTI-HS, FDA partner to study patients' preferences that contributed to approval of new obesity device

SynTheAll Pharmaceutical wins 2015 CMO Leadership Award

UofL study investigates safety, effectiveness of EBV for treating emphysema symptoms

Bronchial thermoplasty for severe asthma: an interview with Dr. Rob Niven

genae announces acquisition of e-novex

Neuromod Devices, Irish Tinnitus Association announce launch of Tinnitus Awareness Week 2015

Nevro gets FDA approval letter for Senza spinal cord stimulation system

Gastroenterology publishes landmark data from RESPECT study of Transoral Incisionless Fundoplication procedure

K2M obtains FDA approval to market MESA 2 Deformity Spinal System

Clarkston Consulting releases 2015 Life Sciences Trends Report

Echo Therapeutics re-establishes operational and strategic partnership with MTIA

Johnson & Johnson announces sales of $18.3 billion for Q4 2014

Gecko Biomedical obtains 1.3 million euros to advance Bio-inspired Surgical Solutions

First medical device approved for treatment of obesity

Signostics gets FDA 510k clearance for handheld bladder scanner

YODA Project announces availability of clinical trial data for medical devices

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

Latest News