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Sorin Group initiates PERSIST-AVR trial to evaluate Perceval sutureless aortic valve against standard sutured bioprostheses

Sorin Group, a global medical device company and a leader in the treatment of cardiovascular diseases, today announced the initiation of PERSIST-AVR, the first international, prospective, post-market randomized multi-center trial evaluating the Perceval sutureless aortic valve compared to standard sutured bioprostheses in patients with aortic valve disease.

7 Oct 2015

Vertera Spine receives FDA 510(k) clearance for COHERE Cervical Interbody Fusion Device

Vertera Spine, a developer of medical devices with advanced functional surface technologies for spine applications, today announced it has received U.S. Food and Drug Administration 510(k) clearance for its COHERE Cervical Interbody Fusion Device.

6 Oct 2015

MU Health Care wins global HIMSS Enterprise Nicholas E. Davies Award of Excellence

University of Missouri Health Care has received the global HIMSS Enterprise Nicholas E. Davies Award of Excellence for health care technology innovations that are improving patient outcomes.

6 Oct 2015

Researchers design specialized catheter for fixing holes in the heart

Researchers from Boston Children's Hospital, the Wyss Institute for Biologically Inspired Engineering at Harvard University, Harvard John A. Paulson School of Engineering and Applied Sciences and the Karp Lab at Brigham and Women's Hospital have jointly designed a specialized catheter for fixing holes in the heart using a biodegradable adhesive and patch.

6 Oct 2015

Oraya therapy is effective in maintaining vision with reduced injections for wet AMD patients

The results show that Oraya Therapy is effective in maintaining vision with reduced injections for patients at different stages of their disease—from chronic patients in discontinuous treatment to treatment-naive patients with new diagnosis—and following different treatment pathways.

1 Oct 2015

New Cerebral Aneurysm and AVMs modules broaden scope of NeuroVascular Quality Initiative

The Society of NeuroInterventional Surgery and M2S, a leading clinical registry provider, are pleased to announce the launch of the new Cerebral Aneurysm module for the NeuroVascular Quality Initiative (NVQI®), and the planned launch for the Cerebral Arteriovenous Malformations (AVMs) module in early October.

30 Sep 2015

New self-contained device could provide instant results to routine lab tests, accelerate treatment and diagnosis

Researchers at Houston Methodist, along with collaborators at two major Singapore institutions, have developed a lab in a needle device that could provide instant results to routine lab tests, accelerating treatment and diagnosis by days.

29 Sep 2015

Lumenis launches UltraPulse DUO at 119th AAO-HNSF Annual Meeting

Lumenis Ltd., the world's largest energy-based medical device company for surgical, aesthetic and ophthalmic applications, announced the launch of the UltraPulse DUO at the 119th Annual American Academy of Otolaryngology - Head and Neck Surgery Foundation (AAO-HNSF) Annual Meeting, taking place September 27 - 30, 2015 in Dallas, Texas.

From Lumenis Inc. 29 Sep 2015

OJ-Bio to showcase new smartphone-enabled diagnostic testing device at Medica 2015

Advanced smartphone-enabled medical device technology for the rapid and cost-effective detection of infectious diseases will be featured at this year’s prestigious Medica show.

29 Sep 2015

Philip Chapper & Co to showcase new partner products at Europe’s largest pharmaceutical trade fair

Philip Chapper & Company Ltd, a UK company with over 40 years’ experience within medical supplies, is to showcase innovative products from new suppliers at the industry’s largest European trade fair.

28 Sep 2015

Free compliance guide for medical device suppliers solving the clinical evaluation report puzzle

In a bid to help clarify the all-but-transparent requirements needed In a bid to help clarify the all-but-transparent requirements needed to produce a compliant Clinical Evaluation Report (CER), Maetrics, a leading international consulting firm focused on the life sciences sector, has drafted a free go-to guide for Medical Device manufacturers downloadable here: Maetrics guide.

23 Sep 2015

NJIT President Joel Bloom to be honored as Educator of the Year

The Research & Development Council of New Jersey will honor the winners of the 2015 Edison Patent Awards at the 36th Edison Patent Awards Ceremony & Reception on November 12, 2015. Over 50 inventors and 12 New Jersey companies and universities will be recognized at the event.

23 Sep 2015

VolitionRx's NuQ blood test receives CE Mark approval for detection of colorectal cancer

VolitionRx Limited today announced the Company's first CE Mark for its blood-based diagnostic assay, NuQ X001S, for detection of colorectal cancer. The NuQ test utilizes the Company's proprietary Nucleosomics technology platform, which identifies and analyses fragments of chromosomes, called nucleosomes, circulating within the blood for the presence of epigenetic cancer signals.

22 Sep 2015

Patient dedicated blood gas analyzer from Proxima showcased at NVIC Najaarscongres

Sphere Medical, innovator in critical care monitoring and diagnostics equipment, will be exhibiting for the first time in The Netherlands its new patient dedicated arterial blood gas system. Attendees of the NVIC (Dutch Intensive Care Society) Najaarscongres 2015, in Utrecht from 17-18th September will be able to find out how the new Proxima System supports rapid and frequent measurements without leaving the patient’s bedside.

17 Sep 2015

Pipetting Solutions for Sample Screening

Our research focuses on interleukin 1 and the inflammasome and their role in innate immunity and inflammation.

From INTEGRA Biosciences 16 Sep 2015

Fusion IONZ’s non-thermal far infrared technology successfully passes board certified clinical trial

Fusion IONZ has successfully commissioned and passed a three phase human clinical trial. This clinical trial was conducted by the Dr. Lisa Tully and the Energy Medicine Research Institute.

15 Sep 2015

Mitral valve disease patients enrolled in Harpoon’s Early Feasibility Study with 100% procedural success

Harpoon Medical, a medical device company focused on minimally-invasive, beating-heart, mitral valve repair, announced today that ten patients with severe degenerative mitral valve disease are now enrolled in its ongoing Early Feasibility Study at two clinical study sites in Europe.

15 Sep 2015

Philips, Radboudumc introduce first diabetes prototype system

Royal Philips and Netherlands-based Radboud university medical center today introduced a connected digital health prototype that enables people living with diabetes and their health care providers to make more confident care decisions while managing the complexity of diabetes self-care. In its first phase, the solution both organizations are developing will focus on patients living with diabetes type 1.

15 Sep 2015

BfArM approves Greenovation’s moss-aGal phase I clinical trial for Fabry disease

Greenovation Biotech GmbH announced today that it has received approval to begin a phase I clinical trial in Europe for its first drug candidate moss-aGal (agalsidase) from Germany's regulatory authority, the Federal Institute for Drugs and Medical Devices (BfArM).

15 Sep 2015

Surgeons use 3D printed implant in patient diagnosed with chest wall sarcoma

After being diagnosed with a chest wall sarcoma, a 54-year-old Spanish man's surgical team made the decision to remove his sternum and a portion of his rib cage and replace it with an implant.

14 Sep 2015

Medical Devices News and Research

Sorin Group initiates PERSIST-AVR trial to evaluate Perceval sutureless aortic valve against standard sutured bioprostheses

Vertera Spine receives FDA 510(k) clearance for COHERE Cervical Interbody Fusion Device

MU Health Care wins global HIMSS Enterprise Nicholas E. Davies Award of Excellence

Researchers design specialized catheter for fixing holes in the heart

Oraya therapy is effective in maintaining vision with reduced injections for wet AMD patients

New Cerebral Aneurysm and AVMs modules broaden scope of NeuroVascular Quality Initiative

New self-contained device could provide instant results to routine lab tests, accelerate treatment and diagnosis

Lumenis launches UltraPulse DUO at 119th AAO-HNSF Annual Meeting

OJ-Bio to showcase new smartphone-enabled diagnostic testing device at Medica 2015

Philip Chapper & Co to showcase new partner products at Europe’s largest pharmaceutical trade fair

Free compliance guide for medical device suppliers solving the clinical evaluation report puzzle

NJIT President Joel Bloom to be honored as Educator of the Year

VolitionRx's NuQ blood test receives CE Mark approval for detection of colorectal cancer

Patient dedicated blood gas analyzer from Proxima showcased at NVIC Najaarscongres

Pipetting Solutions for Sample Screening

Fusion IONZ’s non-thermal far infrared technology successfully passes board certified clinical trial

Mitral valve disease patients enrolled in Harpoon’s Early Feasibility Study with 100% procedural success

Philips, Radboudumc introduce first diabetes prototype system

BfArM approves Greenovation’s moss-aGal phase I clinical trial for Fabry disease

Surgeons use 3D printed implant in patient diagnosed with chest wall sarcoma

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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