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No End in Sight for Megamerger in Healthcare Technology

February 12, 2015 9:42 am | by AAMI | News | Comments

The megamerger trend in the healthcare technology industry shows no signs of slowing, as companies seek to diversify in additional therapeutic areas and expand their business dealings with hospitals as the market becomes increasingly...

Miniaturized Cardiac Monitors Detect Atrial Fibrillation in Stroke Patients

February 11, 2015 11:01 am | by Medtronic | News | Comments

Medtronic plc today announced the results of a new “real-world” study of patients who have had a cryptogenic stroke (stroke of unknown cause), in which the Reveal LINQ Insertable Cardiac Monitor (ICM) detected atrial...

Country’s Smallest Pediatric Mechanical Heart Valve

February 11, 2015 10:46 am | by St. Jude Medical | News | Comments

St. Jude Medical, Inc.,  a global medical device company, today announced the launch of the HALO U.S. IDE Trial. The trial will evaluate the safety and efficacy of the St. Jude Medical Masters HPTM Series 15mm heart...

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Flex Embolization Device Receives FDA Approval

February 5, 2015 3:38 pm | by Medtronic | News | Comments

Medtronic plc, a global leader in medical technology, services and solutions, announced today that it has received U.S. Food and Drug Administration (FDA) approval for its Pipeline Flex embolization device.  Available through a limited U.S. launch...

The CARDIS Project: Detecting Early-Stage Cardiovascular Disease

February 2, 2015 3:55 pm | by Imec | News | Comments

Imec, Medtronic, Ghent University and their project partners today announced the launch of the CARDIS project. Together they will develop and validate an early-stage cardio vascular disease detection platform using integrated silicon photonics...

CoreValve System Benefits Patients with Prior Coronary Bypass Surgery

February 1, 2015 10:00 am | by Medtronic | News | Comments

Medtronic plc revealed new one-year clinical data showing that transcatheter aortic valve replacement (TAVR) with the self-expanding CoreValve System offers advantages in survival and safety compared to surgical aortic valve replacement (SAVR)...

2015 Will Produce Innovative, Cost Effective Cardiovascular Technology

February 1, 2015 8:30 am | by Dr. Mark Carlson, Chief Medical Officer, St. Jude Medical | Blogs | Comments

This year has been a dynamic year as the medical device sector continues to adapt to the changing healthcare environment. As an industry, we are called to develop innovative solutions that address prevalent, devastating, and costly conditions...

2015 Will Require Implementation of Thorough Security Programs

January 28, 2015 8:30 am | by Michael McNeil, Product Security & Services Officer, Philips Healthcare | Blogs | Comments

In April of 2014, Wired Magazine made the rattling proclamation that “it’s insanely easy to hack hospital equipment,” citing cybersecurity researcher Scott Erven’s two years of medical device vulnerability investigations and the many ways in...

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Medtronic Completes Acquisition of Covidien

January 26, 2015 5:31 pm | by Medtronic | News | Comments

Medtronic plc, a global leader in medical technology, services and solutions, announced today that it has successfully completed the previously announced acquisition of Covidien plc. Under the terms of the acquisition agreement, Medtronic...

FDA Approves Implantable Neurostimulator to Treat Serious Stomach Disorder

January 23, 2015 9:42 am | by The Associated Press | News | Comments

Medtronic, Inc. today announced it has received United States Food and Drug Administration (FDA) approval, under a humanitarian device exemption* (HDE), for the Medtronic Enterra II System. The system is used to treat chronic, intractable...

Using Sound Waves to Heat-Treat Cancer Pain

January 23, 2015 8:51 am | by Focused Ultrasound Foundation | News | Comments

A pioneering clinical trial is testing whether focusing high-frequency sound waves onto the surface of bone where cancer has spread can burn away the source of pain. The cutting-edge technique focuses ultrasound beams to produce heat – just...

Designing a Smarter Trial, Earlier

January 21, 2015 1:58 pm | by Vicki Anastasi, VP and Global Head of Medical Device and Diagnostics Research, ICON | Blogs | Comments

Increased regulatory and reimbursement burden has made development timelines longer than ever. As regulators and payers demand more evidence to demonstrate safety, efficacy, and value, manufacturers must design smarter trials that collect...

Using Light to Beat the Winter Blues

January 21, 2015 10:13 am | by Philips Healthcare | News | Comments

Join Royal Philips, the global leader in lighting to beat the most depressing day of the year. According to a study by Cliff Arnall, the most depressing date of the year is today and is amongst others due to the weather conditions and lack of sun...

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Insulin Pump Moves One Step Closer to an Artificial Pancreas

January 21, 2015 9:42 am | by Medtronic, Inc. | News | Comments

Medtronic, Inc. today announced the start of the global launch of the MiniMed 640G System, the next breakthrough toward an artificial pancreas.  With the introduction of Medtronic's exclusive SmartGuard technology, MiniMed 640G is designed to...

Philips and Indica Labs Team Up for Advanced Image Analysis of Cancer

January 15, 2015 10:52 am | by Philips | News | Comments

Royal Philips today announced that it will further support oncology researchers’ efforts to analyze pathology samples by offering advanced image analysis algorithms from Indica Labs, Inc. as part of its Digital Pathology Solutions offerings...

FDA Approves Fetal Monitoring System that Allows Freedom of Movement During Labor

January 9, 2015 10:14 am | by Philips | News | Comments

Royal Philips today announced that it received 510(k) clearance from the U.S.A. Food and Drug Administration (FDA) to market its Avalon CL Fetal Monitoring solution (Avalon CL). The solution provides consistent monitoring of the... 

Drug-Coated Angioplasty Balloon Approved for Peripheral Arterial Disease Patients

January 9, 2015 9:27 am | by Covidien | News | Comments

Covidien plc today announced it has received CE Mark approval for its Stellarex drug-coated angioplasty balloon (DCB). The Stellarex DCB is used to restore and maintain blood flow to the arteries of the leg in patients with peripheral arterial...

Top Five Healthcare Trends of 2014

January 2, 2015 10:31 am | by Kalorama Information | News | Comments

Kalorama Information has identified its “Top Five Trends in Healthcare in 2014.” The healthcare market research firm publishes 40-50 detailed studies in healthcare markets every year. The firm said several events in 2014 will have business planners...

Big Data and Analytics Still a Driver for Future Change

December 26, 2014 8:02 am | by Andrew Rebhan, Analyst for Medical Devices & Healthcare IT, IHS Inc. | Blogs | Comments

Healthcare delivery models have already started the shift away from volume-based care in order to focus more on delivering higher value for patients. The need for integrated care and interoperability among disparate IT systems, along with the rise in newly...

Device Market Reaches $361 Billion in 2014

December 23, 2014 10:12 am | by Kalorama Information | News | Comments

The global market for medical devices was estimated to reach 361 billion dollars by year’s end. While that’s a lot of revenue, the report says it reflects slower growth than many in the industry would have liked to see. With 3% average growth, the healthcare...

Stryker Will Pay About $80M to End Investigation

December 9, 2014 11:46 am | by The Associated Press | News | Comments

The medical device maker Stryker will pay about $80 million to end a federal investigation into its acquisition of a company that the U.S. said was marketing a product that hadn't been approved by regulators. The company said that the U.S...

Sale of Three Siemens Healthcare Units Raises Questions About Firm’s IVD Future

December 3, 2014 10:41 am | by Kalorama Information | News | Comments

The announced sales of three healthcare units within Siemens Healthcare may indicate the company is looking to expand in non-healthcare areas, says Kalorama Information. Siemens hasn’t announced any further sales. The healthcare market research...

Medtronic-Covidien Transaction Gains Key Clearances

December 1, 2014 9:17 am | by Medtronic | News | Comments

Medtronic, Inc. and Covidien plc have announced the receipt of U.S. Federal Trade Commission (FTC) clearance of Medtronic's proposed acquisition of Covidien. "This regulatory clearance represents an important milestone in bringing our companies...

2014: The Year of Healthcare M&As

November 24, 2014 12:04 pm | by Linda A. Johnson and Steve Rothwell, AP Business Writers | News | Comments

Some big, U.S. pharmaceutical, biotech and medical device companies have been trying to acquire overseas rivals, allowing them to move their headquarters to a country with a lower tax rate. The deals also give the buyer access to billions in...

Cancer Device Gets Stronger Warning from FDA

November 24, 2014 11:58 am | by The Associated Press | News | Comments

U.S. regulators have strengthened their warning against use of a once-popular device for gynecologic surgery that can spread unsuspected cancer, saying its risk is only justified in a fraction of patients. The Food and Drug Administration is updating...

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