3D-Printing Method Uses Multiple Materials At Once, Expands Personalized Medicine Options
Researchers from Dresden have introduced additive manufacturing (AM) technology that can work with multiple materials at the same time, giving greater design flexibility to the 3D printing process. Their technique — which can work with any combination of plastic, glass, ceramics, or metal — would allow for the quicker production of more complex and personalized bone implants, dentures, or surgical tools. (Source: Medical Design Online News)
Source: Medical Design Online News - April 13, 2016 Category: Medical Equipment Source Type: news

Profusa Awarded $1.75M NIH Grant To Further Develop Tissue-Integrated Biosensors For Continuous Oxygen Monitoring In PAD Patients
Profusa, Inc., a leading developer of tissue-integrated biosensors, today announced that the National Institutes of Health has awarded it a $1.75 million grant under the Small Business Innovation Research (SBIR) program. Adminis­tered by the National Heart, Lung, and Blood Institute (NHLBI), the funding will support Fast-tracked Phase I and Phase II studies of the company's Lumee™ tissue-integrated biosensors for continuous monitoring of oxygen toward improving the clinical outcomes of patients suffering from peripheral artery disease (PAD). (Source: Medical Design Online News)
Source: Medical Design Online News - April 13, 2016 Category: Medical Equipment Source Type: news

Stroke Prevention: BIOTRONIK Announces FDA Approval Of BioMonitor 2 Insertable Cardiac Monitor
BIOTRONIK, a leader in cardio- and endovascular medical technology, today announced Food and Drug Administration (FDA) approval of BioMonitor 2, an insertable cardiac remote monitor with ProMRI® technology. (Source: Medical Design Online News)
Source: Medical Design Online News - April 13, 2016 Category: Medical Equipment Source Type: news

04.14.16 -- IBM Developing Brain Implant | U.S. TAVR Market Guide
04/14/16Med Device Online Newsletter (Source: Medical Design Online News)
Source: Medical Design Online News - April 13, 2016 Category: Medical Equipment Source Type: news

Nanotechnology Critical Cleaning For Quality & Safety
Nanotechnology is currently employed across a wide range of industrial, research, and academic applications. Stringent cleaning protocols are essential to the successful fabrication of nanotechnology particles, structures, and systems. (Source: Medical Design Online News)
Source: Medical Design Online News - April 12, 2016 Category: Medical Equipment Source Type: news

Study To Evaluate Minimally Invasive Laser Therapy For Refractory Epilepsy Patients
The FDAhas approved Monteris Medical's Investigational Device Exemptionto evaluate its NeuroBlateSystem in medically refractory epilepsy. With this approval, Monteris will initiate theFeasibility Study onLaser Interstitial ThermalAblation for the Treatment of MedicallyRefractoryEpilepsy (FLARE). This multicenter, open-label prospective study is expected to enroll up to 45 subjects at as many as eight clinical sites in the U.S. (Source: Medical Design Online News)
Source: Medical Design Online News - April 12, 2016 Category: Medical Equipment Source Type: news

IBM Aims To Make Brain Implant To Predict, Stop Seizures
IBM is creating a computing system, called a neural network and powered by the company's TrueNorth chip, that can study the brain wave patterns that indicate a seizure. The company hopes that such a system could someday be built into mobile devices which can warn, and possibly even prevent, epileptic seizures. (Source: Medical Design Online News)
Source: Medical Design Online News - April 12, 2016 Category: Medical Equipment Source Type: news

Samsung Manufacturer, British Startup Partner On Touchless Patient Monitoring
Oxehealth, a spin-out of Oxford University, successfully piloted a contact-free video monitoring system last year that can track five different patient vital signs using camera images and computer algorithms. The British startup has now partnered with Hanwha Techwin (formerly Samsung Techwin) to bring the system to market, where it is expected to improve patient monitoring in both hospitals and at-home care environments while alleviating pressure on healthcare staff. (Source: Medical Design Online News)
Source: Medical Design Online News - April 12, 2016 Category: Medical Equipment Source Type: news

St. Jude Medical Announces US Launch And First Commercial Implants Of DRG Stimulation Therapy
St. Jude Medical, Inc., a global medical device company, recently announced the U.S. launch and first post-approval implants of the St. Jude Medical AxiumNeurostimulator System for dorsal root ganglion (DRG) stimulation to treat patients with chronic pain that has been hard to control with traditional spinal cord stimulation (SCS). (Source: Medical Design Online News)
Source: Medical Design Online News - April 12, 2016 Category: Medical Equipment Source Type: news

FDA Approves First-Of-Its-Kind Container Bag For Certain Power Morcellator Procedures
The U.S. Food and Drug Administration (FDA) has approved through the de novo classification process PneumoLiner, a first-of-its-kind tissue container bag for use in certain laparoscopic power morcellator procedures to isolate uterine tissue that is not suspected to be cancerous. (Source: Medical Design Online News)
Source: Medical Design Online News - April 11, 2016 Category: Medical Equipment Source Type: news

04.12.16 -- World's Smallest Pacemaker Approved | Is Medtech Innovation Doomed?
04/12/16 Med Device Online Newsletter (Source: Medical Design Online News)
Source: Medical Design Online News - April 11, 2016 Category: Medical Equipment Source Type: news

FTC: Web-Based Tool Clarifies Law For Mobile App Developers
The Federal Trade Commission (FTC) — in collaboration with FDA, the Office of National Coordinator for Health Information Technology (ONC), and the Office for Civil Rights (OCR) — has launched a new interactive tool that mobile app developers can use to clarify what regulations and laws apply to their health and wellness products. The initiative aims to better protect consumer safety and privacy while encouraging the development of innovative digital health technology. (Source: Medical Design Online News)
Source: Medical Design Online News - April 11, 2016 Category: Medical Equipment Source Type: news

Abiomed Impella® Therapy Receives FDA Approval For Cardiogenic Shock After Heart Attack Or Heart Surgery
Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support technologies, today announced that it has received U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) for its Impella 2.5™, Impella CP®, Impella 5.0™ and Impella LD™ heart pumps to provide treatment of ongoing cardiogenic shock. (Source: Medical Design Online News)
Source: Medical Design Online News - April 11, 2016 Category: Medical Equipment Source Type: news

St. Jude Medical Announces The European Launch Of The Trifecta Surgical Valve With Glide Technology To Improve Options For Patients In Need Of Aortic Valve Replacement
St. Jude Medical, Inc. , a global medical device company, recently announced the European launch of the company’s most advanced tissue valve — the Trifecta valve with Glide Technology (GT) — for the treatment of diseased, damaged or malfunctioning aortic heart valves, which control blood flow from the heart to the rest of the body. (Source: Medical Design Online News)
Source: Medical Design Online News - April 11, 2016 Category: Medical Equipment Source Type: news

New Liquid Biopsy RAS Testing For Metastatic Colorectal Cancer Patients Now Available For Clinical Practices
Sysmex Inostics, a subsidiary of Sysmex Corporation, today announced that its OncoBEAM® RAS CRC test has been granted CE Mark approval. The test, developed by Sysmex Inostics GmbH in collaboration with Merck, can now be accessed by patients with metastatic colorectal cancer (mCRC) across Europe. The OncoBEAM® RAS CRC assay has been shown to have similar performance to conventional tissue-based testing[1]-[3] and can be used to determine which patients would benefit from anti-EGFR therapies, such as Erbitux, as demonstrated by recent data. (Source: Medical Design Online News)
Source: Medical Design Online News - April 8, 2016 Category: Medical Equipment Source Type: news