Medical Devices News and Research

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First Edition: September 30, 2013

Today's headlines include reports about the readiness of the health law's online marketplaces and other key provisions the day before their Oct. 1 launch date even as the looming government shutdown becomes more of a reality.

30 Sep 2013

House votes to delay health law, repeal medical device tax

Senate Democrats say they cannot accept the provisions in House GOP's newest bill to fund the government. Without agreement between Senate and House, the government could shut down Tuesday.

30 Sep 2013

JDRF applauds FDA approval of Medtronic's MiniMed 530G with Enlite system for T1D

JDRF, the leading global organization funding type 1 diabetes research, today applauded the U.S. Food and Drug Administration for its commitment to ensuring patients in the United States can access insulin pumps that can temporarily stop insulin delivery once sensor glucose levels fall below a predetermined threshold.

From Medtronic 29 Sep 2013

BD, WHO commit to develop and launch Odon Device for assisted delivery of newborns

BD, a leading global medical technology company, and the World Health Organization, together with Saving Lives at Birth: A Grand Challenge for Development partners, today announced a commitment to develop and launch the Odon Device, an innovative new obstetrical instrument for assisting the delivery of newborns during circumstances of troublesome labor.

From BD (Becton, Dickinson and Company) 27 Sep 2013

GOP considers shutdown alternatives

Republicans are exploring a possible new strategy: shifting the fight over President Barack Obama's health-care law to a separate bill that would raise the nation's debt limit. Other media outlets report that the debt limit deadline is Oct. 17 -- about two weeks earlier than had been anticipated.

27 Sep 2013

Allergan Licenses Rights To Medytox Candidates, In Up-To-$362M Deal

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26 Sep 2013

Biosearch Technologies Acquires Majority Stake In Lightspeed Genomics

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26 Sep 2013

First Edition: September 26, 2013

Today's headlines include details regarding the ongoing congressional battle over the future of the health law in the context of avoiding a government shutdown, as well as the developments on the ground as the Oct. 1 launch of the health law's insurance marketplace nears.

26 Sep 2013

Lawmakers weigh deal giving FDA reater clout after meningitis outbreak

House and Senate negotiators appear to be making progress towards stiffer regulations over the type of drugs that caused last year's outbreak. In other Capitol Hill news, the GOP pushes to repeal a tax on medical devices, and rural health care providers ask for more time to meet electronic health record deadlines.

26 Sep 2013

FDA awards grants to boost development, availability of medical devices for children

The U.S. Food and Drug Administration today announced it has awarded seven grants totaling more than $3.5 million to various pediatric device consortia to boost the development and availability of medical devices for children.

26 Sep 2013

New computational model to improve treatment of dangerous reactions to medical implants

A team from The University of Texas at Arlington has used mathematical modeling to develop a computer simulation they hope will one day improve the treatment of dangerous reactions to medical implants such as stents, catheters and artificial joints.

25 Sep 2013

FDA says most smartphone health apps won't get regulatory scrutiny

The federal agency will reserve its attention for apps that function like medical devices.

25 Sep 2013

Red River partners with Firetide to launch new healthcare IT division

New Hampshire-based Red River, a leading information technology services provider, announced a partnership today between Red River Healthcare and Firetide, a provider of wireless infrastructures that enable multimedia services for federal and commercial customers, as part of the launch of Red River's new healthcare IT division.

24 Sep 2013

First Edition: September 24, 2013

Today's headlines include reports about Senate action on the effort to defund the health law as well as a scheduled appearance by former President Bill Clinton and President Barack Obama to kick off the roll out of a key part of the overhaul.

24 Sep 2013

FDA approves revised labeling for Sapien Transcatheter Heart Valve

The U.S. Food and Drug Administration today approved revised labeling for the Sapien Transcatheter Heart Valve, making the device available to an expanded group of patients who have inoperable aortic valve stenosis, a disease of the heart valves that causes narrowing of the aortic valve, restricting blood flow from the heart.

24 Sep 2013

Digital devices may contribute to pulse oximetry's role as 'fifth vital sign'

Do you have a smartphone in your pocket or purse? If so, you may be carrying the future of mobile medical monitoring technology, according to a special article in the October issue of Anesthesia & Analgesia, official journal of the International Anesthesia Research Society (IARS).

24 Sep 2013

Rice University researchers come up with touch-to-access security for implanted devices

Pacemakers, insulin pumps, defibrillators and other implantable medical devices often have wireless capabilities that allow emergency workers to monitor patients. But these devices have a potential downside: They can be hacked.

24 Sep 2013

FDA's final guidance outlines tailored approach to mobile medical apps

Today, the U.S. Food and Drug Administration issued final guidance for developers of mobile medical applications, or apps, which are software programs that run on mobile communication devices and perform the same functions as traditional medical devices. The guidance outlines the FDA's tailored approach to mobile apps.

24 Sep 2013

Plenary sessions at AdvaMed 2013 conference to explore new Medicare payment initiatives

The second day of AdvaMed 2013: The MedTech Conference at the Walter E. Washington Convention Center in Washington, D.C., will feature plenary sessions honoring two of the industry's congressional champions and exploring the impact of new Medicare payment initiatives on patient access to medical innovations.

23 Sep 2013

Advamed 2013 conference to focus on global opportunities and challenges in medical technology industry

AdvaMed 2013: The MedTech Conference begins today at the Walter E. Washington Convention Center in Washington, D.C. with a major emphasis on the opportunities and challenges facing the medical technology industry in an increasingly global marketplace.

23 Sep 2013