Publication: Medical Device Daily

First reported Oct 18 2014 - Updated Oct 18 2014 - 1 reports

Medtech Forum 2014: Germans, Dutch launch CED early market access programs

BRUSSELS, Belgium Where coverage with evidence development (CED) programs are well-established, though applied sparingly, in North America such early market access schemes for medical devices are new to Europe. And characteristic of the fragmented regulatory ... [Published Medical Device Daily - Oct 18 2014]
First reported Oct 17 2014 - Updated Oct 17 2014 - 1 reports

Financings: Canaan Partners raises $675M for Fund X after a banner year of exits

After a banner year with a dozen liquidity events, including a handful of exits in the life sciences, Canaan Partners (Menlo Park, California) said it has raised $675 million in commitments for its latest fund, Fund X. The multi-billion venture capital ... [Published Medical Device Daily - Oct 17 2014]
First reported Oct 16 2014 - Updated Oct 16 2014 - 1 reports

Cytomedix undergoes product re-branding along with rebirth

What would probably be considered a huge roadblock for some companies turned into a tremendous opportunity for Cytomedix (Gaithersburg, Maryland) to undergo a re-branding and rebirth. The company develops a wound care product but up until fairly recently, ... [Published Medical Device Daily - Oct 16 2014]
First reported Oct 15 2014 - Updated Oct 15 2014 - 1 reports

Medtronic closer to artificial pancreas, enrolls patients in PLGM tech study

The path towards the development of an artificial pancreas heated up this week, as Medtronic (Minneapolis) reported that the first patients have been enrolled in an investigational device exemption study of its breakthrough Predictive Low Glucose Management ... [Published Medical Device Daily - Oct 15 2014]
First reported Oct 14 2014 - Updated Oct 14 2014 - 1 reports

PPI medications can't keep up in TEMPO, when compared to TIF

Are Transoral Incisionless Fundoplication (TIF) procedures the go-to treatment for relief of GERD symptoms? While it might be a stretch to say that TIF procedures have reached that distinction, one-year results of EndoGastric Solutions'(EGS; San Mateo, ... [Published Medical Device Daily - Oct 14 2014]
First reported Oct 10 2014 - Updated Oct 11 2014 - 1 reports

C.R. Bard scores FDA approval for Lutonix 035 Drug Coated Balloon

C. R. Bard (Murray Hill, New Jersey) reported FDA approval of the Lutonix 035 Drug Coated Balloon (DCB) catheter for percutaneous transluminal angioplasty (PTA), after pre-dilatation, for the treatment of de novo or restenotic lesions up to 150mm in length ... [Published Medical Device Daily - Oct 10 2014]
First reported Oct 10 2014 - Updated Oct 10 2014 - 1 reports

Watchman ekes out narrow win for risk/benefit, but indication an issue

The FDA circulatory system devices panel voted narrowly that the benefits outweigh the risks for the Watchman left atrial appendage (LAA) closure device made by Boston Scientific (BSX; Boston, Massachusetts), putting FDA on the spot for a device the agency ... [Published Medical Device Daily - Oct 10 2014]
First reported Oct 08 2014 - Updated Oct 08 2014 - 1 reports

Payers said to see overwhelming data problem with next-gen Dx

CHICAGO Where healthcare is concerned, "big data" are said to come with big problems, but data associated with so-called next-generation diagnostics are also problematic. An Oct. 7 session at AdvaMed 2014 tackled the subject of how payers react to requests ... [Published Medical Device Daily - Oct 08 2014]
First reported Oct 08 2014 - Updated Oct 08 2014 - 1 reports

AdvaMed 2014: Covidien's Tarnoff welcomes closer collaboration with FDA and CMS

CHICAGO In recent years, FDA and CMS have made great strides towards finding ways to streamline and accelerate patient access to new technologies. Their efforts culminated in a parallel review pilot program that is currently slated to run through 20 ... [Published Medical Device Daily - Oct 08 2014]
First reported Oct 06 2014 - Updated Oct 06 2014 - 1 reports

AdvaMed 2014: Analysis of private payer use of P4P sparks concerns at AdvaMed

CHICAGO It's not news that the payment reform movement is making its way into the private sector, but a recent study has sparked fresh concerns that payers are driving clinical decision making in a direction that might blunt utilization to the detriment ... [Published Medical Device Daily - Oct 06 2014]
First reported Oct 04 2014 - Updated Oct 04 2014 - 1 reports

AdvaMed 2014: Medtronic founder Earl Bakken slated to appear at AdvaMed 2014

The annual meeting sponsored by the Advanced Medical Technology Association (AdvaMed; Washington) will land this year at Chicago's McCormick Place, replete with a fine view of Lake Michigan, but there are two celebrities poised to address the gathering ... [Published Medical Device Daily - Oct 04 2014]
First reported Oct 03 2014 - Updated Oct 03 2014 - 1 reports

GlobalMed touts telemedicine as weapon against Ebola outbreak

The most effective weapon against Ebola may be the use of telemedicine technology, according to Joel Barthelemy, CEO of GlobalMed (Scottsdale, Arizona), a firm that develops integrated telemedicine solutions for healthcare providers and corporate health ... [Published Medical Device Daily - Oct 03 2014]

Quotes

"It might be easier to do you own study, get more countries to participate and get your data really quickly" she suggested
"We invest to an M&A or an IPO exit, we're prepared to follow a company all the way through," Hutton said. "In terms of our medical device strategy, we focus on large market opportunities where there's still an unmet clinical need. We are very interested in areas where we can avoid some of the risks around reimbursement ... clinical areas where reimbursement already exists or there's a large patient-pay component, areas like dermatology or ophthalmology."
"With this coverage decision, now we have the opportunity to take this product into the wound care market place, which is what the company set outout to do back in the beginning, when the product was first developed" he said

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All (22) | News (22) | Reports (0) | Blogs (0) | Audio/Video (0) | Fact Sheets (0) | Press Releases (0)
sort by: Date | Relevance
Medtech Forum 2014: Germans, Dutch launch CED e... [Published Medical Device Daily - Oct 18 2014]
Financings: Canaan Partners raises $675M for Fu... [Published Medical Device Daily - Oct 17 2014]
Cytomedix undergoes product re-branding along w... [Published Medical Device Daily - Oct 16 2014]
Medtronic closer to artificial pancreas, enroll... [Published Medical Device Daily - Oct 15 2014]
PPI medications can't keep up in TEMPO, when co... [Published Medical Device Daily - Oct 14 2014]
C.R. Bard scores FDA approval for Lutonix 035 D... [Published Medical Device Daily - Oct 10 2014]
Watchman ekes out narrow win for risk/benefit, ... [Published Medical Device Daily - Oct 10 2014]
Payers said to see overwhelming data problem wi... [Published Medical Device Daily - Oct 08 2014]
AdvaMed 2014: Covidien's Tarnoff welcomes close... [Published Medical Device Daily - Oct 08 2014]
AdvaMed 2014: Analysis of private payer use of ... [Published Medical Device Daily - Oct 06 2014]
AdvaMed 2014: Medtronic founder Earl Bakken sla... [Published Medical Device Daily - Oct 04 2014]
GlobalMed touts telemedicine as weapon against ... [Published Medical Device Daily - Oct 03 2014]
FDA said to have reclaimed role of 'leading arb... [Published Medical Device Daily - Sep 30 2014]
Intersect ENT touts RESOLVE, begins focus on pi... [Published Medical Device Daily - Sep 29 2014]
Seno completes study enrollment for opto-acoust... [Published Medical Device Daily - Sep 24 2014]
SinuSys' Vent-Os holds up after one year, data ... [Published Medical Device Daily - Sep 23 2014]
TCT 2014: Doc says 40-year old patient may be b... [Published Medical Device Daily - Sep 19 2014]
TCT 2014: BVS outcomes seen as satisfactory, bu... [Published Medical Device Daily - Sep 18 2014]
Early data from ABSORB II seem iffy; device cur... [Published Medical Device Daily - Sep 17 2014]
26th TCT symposium in Washington: Economist say... [Published Medical Device Daily - Sep 15 2014]
UVA doctors explore image-guided, high-dose app... [Published Medical Device Daily - Sep 15 2014]
Blood test shows promise in fight against color... [Published Medical Device Daily - Sep 12 2014]
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