Angel Medical Systems' AngelMed Guardian System

The AngelMed Guardian System is a cardiac monitoring system designed for use in patients who have suffered acute coronary syndrome events before, to detect quick ST elevation changes potentially linked to coronary ischemia. 

The system consists of an implantable device, an external component, and a programmer. 

The AngelMed Guardian System's PMA application is being reviewed at the same March meeting of the ...

January 22nd, 2016
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St. Jude Medical's Axium Neurostimulator System

St. Jude Medical's Axium Neurostimulator System came to the company with the acquisition of Spinal Modulation, Inc. in May 2015. Axium is designed to offer pain relief using dorsal root ganglion (DRG) stimulation.

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January 22nd, 2016
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TransEnterix's SurgiBot

TransEnterix is hoping to enter the U.S. robotic surgery market in 2016 with its SurgiBot System. This would be a major entrance, as the market has been dominated by Intuitive Surgical for several years. According to the company's website, the SurgiBot enables the surgeon to perform single-port laparoscopic procedures at the patient's side with robotic assistance.  

The company submitted a 510(k) application to FDA on June 1, 2015 and is anticipating clearance in the first quarter of 2016. If so, a U.S. launch is planned for the...

January 22nd, 2016
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Endologix's Nellix

Endologix's Nellix EndoVascular Aneurysm Sealing (EVAS) system is intended for treatment of patients with abdominal aortic aneurysms (AAA) located below the renal arteries. The device is different from other endovascular AAA repair systems because it is designed to seal the aneurysm sac. 

According to the corporate website, Nellix may offer ease-of-use, ability to be used in a wider range of patient anatomies, and the possibility of fewer reinterventions to treak...

January 22nd, 2016
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Abbott's Absorb GT1

Abbott's Absorb GT1 Bioresorbable Vascular Scaffold (BVS) is a drug-eluting device that is used in angioplasty to open a narrowed coronary artery. The scaffold eventually dissolves, so patients no longer have a foreign device in their arteries.

Absorb received CE Mark back in January 2011, making it the first drug-eluting BVS to be approved. The Absorb GT1 with the GlideTrack catheter received CE Mark in May 2015. Competitor Boston Scientific's Synergy received FDA approval in October 2015 and is the first...

January 22nd, 2016
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With a new year comes new medtech innovation. Here are some of the medical devices that are expected to be ready for the U.S. market in 2016. 

While regulatory approvals and clearances are never certain, there are a number of medical devices poised to make their debut in the United States in 2016. These new products, which range from a robotic surgery system to a quadripolar lead, are expected to energize customers, intrigue early adopters, or help companies regain level footing with competitors.

Here are 10 medical devices expected to receive FDA approval or clearance this year.

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January 22nd, 2016
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As healthcare purchasing changes, medical device companies need to develop new sales strategies to keep up.

Brian Chapman and Pete Masloski

 

Economic pressures on the health system have been mounting for years, pushed by demographics, shrinking reimbursements, increasingly expensive therapies, and, ultimately, payer consolidation and reforms. Hospitals are the fulcrum and the pinch point for these pressures. Medtech companies no longer can afford to focus on clinical benefits without seeking other avenues to drive value for their hospital customers. This has led to the key account management imperative: Find a way to create value beyond the product alone for stakeholders beyond traditional clinical buyers.

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January 21st, 2016
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Several noteworthy changes are anticipated in a new FDA guidance document on biological evaluation and biocompatibility testing of medical devices due out sometime this year. 

Audrey Turley

There has been a lot of chatter over the past two years about FDA’s draft guidance on ISO 10993. This chatter is now turning into action, as can be seen in the feedback medical device manufacturers are receiving from FDA through their submissions. A final version of this guidance was expected in December 2015 and is now anticipated during the first quarter of 2016.

The delay is most likely due to heavy discussions at the ISO meetings held in Lund, Sweden, in June 2015. Throughout these meetings...

January 20th, 2016
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New medtech companies receive a slew of advice on reimbursement, regulatory approval, and funding—but there’s one key step they may be missing.

Marie Thibault

FDA, CMS, private insurers, venture capitalists—it sometimes seems new company executives have a dozen different hurdles to leap over at once. 

Joseph Galatowitsch, president of Dymedex Consulting, acknowledges that there are common issues, like reimbursement, regulatory approval, and intellectual property that are integral to medtech companies. But before those questions come into play, Galatowitsch believe it’s most important to focus on the market opportunity "so you know if it's worth it to spend the next...

January 20th, 2016
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CDRH unveils its "patient power" initiative at the same time that a third patients' group rallies against the Center's medical device safety review process.

Jim Dickinson

The New Year broke amid an unusually acrimonious election season characterized by a heightened sense of public dissatisfaction with Washington—and among patient advocacy groups that definitely included FDA, especially its devices Center.

By the second week of January, CDRH had picked up on this with the publication of an ambitious manifesto, 2016-2017 Strategic Priorities, that put patient power front and...

January 19th, 2016
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