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CryoLife On the Path to FDA Approval for Hemostat Device
CryoLife (Atlanta, GA) received an Investigational Device Exemption from FDA regulators for the PerClot bleeding-control device. Armed with an IDE, the company will launch a large-scale study to support its Premarket Approval application.
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Terumo Bolsters Facility in Northern Ireland with 416 New Employees
Terumo BCT (Tokyo, Japan) is bolstering production facility in Northern Ireland with 416 new employees, according to the Belfast Telegraph. The new employees will work in the research and development division for blood transfusion tech.
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Study: Medical Devices Aren't Driver of Skyrocketing Medical Costs
A new study out of Europe refutes the commonly-held idea that medical technology is the core reason for the increase in medical costs. While some types of medical technology do cause a slight increase in the cost of healthcare, many can actually help patients and healthcare providers save money.
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St. Jude's Durata Leads Reborn from the Ashes of Riata
St. Jude Medical may be on the right track with the Durata lead, according to Bloomberg. In the past, the company’s defibrillator leads have been plagued with issues, dampening consumer and investor expectations for the technology.
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Smartphone-Wielding Patients Demand Mobile Healthcare Apps
With many Americans purchasing tablets and smartphones, the demand for mobile health apps is on the rise. However, high demand may exceed the supply of currently-available mobile health systems, according to U.S. News.
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U.S. Medical Costs Dip for the First Time in Decades
The U.S. government’s healthcare reform has received widespread criticism recently—largely for their role in elevating insurance premiums. But the government's policies also could be behind a recent decline in the nation’s healthcare costs. Although the reduction was modest, amounting to 0.1%, it is the first decline in nearly four decades, according to the Wall Street Journal. This time last year, the rate saw a 2.2% increase.
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Analyst Sees Perfect Storm for Medtech Industry
A grim future may await the medical device market, according to Seeking Alpha. If medical device makers fail to adapt to cost pressures and a strict regulatory environment, they could see hampered growth well into the future.
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Medtronic Bone Graft Linked to Male Sterility, Elevated Cancer Risk
The Medtronic Infuse bone graft faces harsh criticism from many players. According to two independent third-party reviews, the device offers performance that is no better than traditional bone grafts. In addition, the Infuse spinal implant carries an increased risk of sterility, cancer, and a variety of other adverse outcomes. The cancer risk, however, seemed to be small, according to data published in the Annals of Internal Medicine.
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Medical Device Hacking Gets Renewed Media Attention
The FDA recently asserted that vulnerabilities in hundreds of medical devices could pose a deadly threat to patients. The mainstream media noticed.
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Siemens Joins Forces With Janssen to Develop Companion Diagnostics
Siemens Healthcare (Malvern, PA) is betting on personalized medicine for the future. As part of this new initiative, the global healthcare giant signed a new deal with Johnson & Johnson for companion diagnostics.
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