Publication: Medical Device Daily

First reported 17 hours ago - Updated 17 hours ago - 1 reports

Boston Sci gains FDA approval for devices in X4, Mini line

By Omar FordStaff WriterBoston Scientific (Natick, Massachusetts) has received approval for additions to its Mini ICD line, and X4 CRT-D family of devices. The company reported receiving FDA approval for the Dynagen Mini and Inogen Mini ICDs, as well ... [Published Medical Device Daily - 17 hours ago]
First reported Apr 16 2014 - Updated Apr 16 2014 - 1 reports

TransEnterix secures $50M from public offering of shares

By Omar FordStaff WriterEight months ago, TransEnterix (Research Triangle Park, North Carolina) was acquired by SafeStitch (Miami) and became a publicly traded company ( Medical Device Daily , Sept. 5, 2013). Through this action, TransEnterix, which develops ... [Published Medical Device Daily - Apr 16 2014]
First reported Apr 15 2014 - Updated Apr 15 2014 - 1 reports

Medtronic faces debilitating U.S. injunction on CoreValve sales

By Amanda PedersenSenior Staff WriterEdwards Lifesciences (Irvine, California) has won an important battle in a six-year patent war with Medtronic (Minneapolis) over Medtronic's CoreValve transcatheter aortic valve replacement (TAVR/TAVI) system.Friday ... [Published Medical Device Daily - Apr 15 2014]
First reported Apr 12 2014 - Updated Apr 12 2014 - 1 reports

New Boston Sci registry to evaluate Vercise DBS in Parkinson's patients

By Amanda PedersenSenior Staff WriterBoston Scientific (Natick, Massachusetts) has enrolled the first patient in a new registry to evaluate clinical outcomes and the economic value of the Vercise deep brain stimulation (DBS) system in patients with Parkinson's ... [Published Medical Device Daily - Apr 12 2014]
First reported Apr 11 2014 - Updated Apr 11 2014 - 1 reports

3-D implantable marker called 'beacon for the radiation oncologist'

By Amanda PedersenSenior Staff WriterThe BioZorb three-dimensional surgical marker improved the ability of radiation oncologists to target radiation treatment for breast cancer, according to a presentation at this year's American Brachytherapy Society ... [Published Medical Device Daily - Apr 11 2014]
First reported Apr 10 2014 - Updated Apr 10 2014 - 1 reports

Restrospective study is favorable for On-X mechanical heart valve

On-X Life Technologies (Austin, Texas), whose mechanical heart valves have been implanted in more than 150,000 patients in more than 90 countries, reported that results from an independent, 50-year retrospective study show that On-X mechanical heart valves ... [Published Medical Device Daily - Apr 10 2014]
First reported Apr 09 2014 - Updated Apr 09 2014 - 1 reports

Medtronic's DCB beats PTA in landmark study

Medtronic (Minneapolis) stole the show in London this past weekend with results from a landmark clinical study showing that its IN.PACT Admiral drug-coated balloon outperformed standard balloon angioplasty in patients with peripheral artery disease (PAD) ... [Published Medical Device Daily - Apr 09 2014]
First reported Apr 08 2014 - Updated Apr 08 2014 - 1 reports

CardioKinetix unveils results of its pooled analysis study

By Omar FordStaff WriterCardioKinetix (Menlo Park, California), a firm that's in the process of developing a catheter-based treatment for heart failure, reported results of a pooled analysis study of the first-of-its-kind catheter-based Parachute Ventricular ... [Published Medical Device Daily - Apr 08 2014]
First reported Apr 05 2014 - Updated Apr 05 2014 - 1 reports

FDA approves first upgradeable neurostimulation system

By Amanda PedersenSenior Staff WriterSt. Jude Medical (St. Paul, Minnesota) said the FDA has approved its Protégé IPG. According to the company, Protégé is the first neurostimulation system that allows spinal cord stimulation (SCS) technology upgrades ... [Published Medical Device Daily - Apr 05 2014]
First reported Apr 04 2014 - Updated Apr 04 2014 - 1 reports

Deals roundup: Cardinal Health to acquire AccessClosure for $320M

By Omar FordStaff WriterThe acquisition of AccessClosure (Santa Clara, California) by Cardinal Health (Dublin, Ohio) could be considered as a one of the largest Cinderella stories in med-tech this year. The small private firm, that develops the Mynx family ... [Published Medical Device Daily - Apr 04 2014]
First reported Apr 03 2014 - Updated Apr 03 2014 - 1 reports

The 'Waiting Game' in Approval Process: Argentina, Brazil slowest in Lat Am to register devices

By Sergio HeldContributing WriterRegulators in Brazil and Argentina are among the slowest in Latin America when it comes to registering new devices. Complicated processes and a chronic shortage of staff have led to long delays in regulatory approvals. ... [Published Medical Device Daily - Apr 03 2014]
Entities: Mercosur, Argentina, Brazil
First reported Apr 02 2014 - Updated Apr 02 2014 - 1 reports

American College of Cardiology 2014 Meeting: Maisel: UDI not a panacea for adverse event reporting snags

By Mark McCartyWashington EditorWASHINGTON Clinicians are typically the first to have a grasp of the precise contours of an adverse event related to a drug or medical device, and FDA is rolling out two programs designed to close some of the gaps in device ... [Published Medical Device Daily - Apr 02 2014]

Quotes

...those with a smaller frame," said Hans-Joachim Trappe, PhD, from University Marien Hospital Herne , Hospital of Ruhr-University (Bochum, Germany). "The Mini ICD not only improves patient comfort, but also provides these patients with innovative technology to help treat life-threatening arrhythmias of the heart."
"I think certainly the public markets and being public is ideal if your company's circumstances support it," he said. "For our company, we have a very dynamic technology that's really going to create a new paradigm in surgical robotics. We have a very big and growing market in surgical robotics. Our price point is at a very attractive place and certainly our features really speak to what surgeons and hospital executives are wanting in the next generation of robotics. For all those reasons I think our public story was really embraced. But I certainly think that the public markets aren't for all med-tech companies. Sometimes companies are playing into a market that's not quite as big; that isn't quite growing that much; or just not as established. I think that's more difficult in the public markets for med-tech investors. I think if all the ingredients come together it's a very viable option and we're glad to be public and we think it suits us well for where we're going in the future."
...[Medtronic's] extreme risk label alone," Wise said. "Also, the lack of a 29 mm Sapien valve would be obviated with XT approval. We would expect [Edwards] to err on the side of generosity to not lose the PR battle and alienate doctors and patients."
...improve the quality of life for patients," said Maulik Nanavaty, president of Boston Scientific's Neuromodulation business in a company statment. "This registry will enable us to provide physicians with a comprehensive, long term view of real world experience and results with the Vercise DBS system for the many patients affected by Parkinson's disease."

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sort by: Date | Relevance
Boston Sci gains FDA approval for devices in X4... [Published Medical Device Daily - 17 hours ago]
TransEnterix secures $50M from public offering ... [Published Medical Device Daily - Apr 16 2014]
Medtronic faces debilitating U.S. injunction on... [Published Medical Device Daily - Apr 15 2014]
New Boston Sci registry to evaluate Vercise DBS... [Published Medical Device Daily - Apr 12 2014]
3-D implantable marker called 'beacon for the r... [Published Medical Device Daily - Apr 11 2014]
Restrospective study is favorable for On-X mech... [Published Medical Device Daily - Apr 10 2014]
Medtronic's DCB beats PTA in landmark study [Published Medical Device Daily - Apr 09 2014]
CardioKinetix unveils results of its pooled ana... [Published Medical Device Daily - Apr 08 2014]
FDA approves first upgradeable neurostimulation... [Published Medical Device Daily - Apr 05 2014]
Deals roundup: Cardinal Health to acquire Acces... [Published Medical Device Daily - Apr 04 2014]
The 'Waiting Game' in Approval Process: Argenti... [Published Medical Device Daily - Apr 03 2014]
American College of Cardiology 2014 Meeting: Ma... [Published Medical Device Daily - Apr 02 2014]
American College of Cardiology 2014 Meeting: Co... [Published Medical Device Daily - Apr 01 2014]
Study supports Covidien's ablation therapy for ... [Published Medical Device Daily - Mar 29 2014]
Industry Deals: Baxter is latest firm to split ... [Published Medical Device Daily - Mar 28 2014]
Benvenue launches Kiva VCF, unveils results fro... [Published Medical Device Daily - Mar 27 2014]
Latin America: Lack of accredited importers mai... [Published Medical Device Daily - Mar 26 2014]
NewCo on the Go: Arch Therapeutics going after ... [Published Medical Device Daily - Mar 25 2014]
Castlight IPO indicative of Health IT bubble [Published Medical Device Daily - Mar 22 2014]
EndoChoice shown to detect more pre-cancerous p... [Published Medical Device Daily - Mar 19 2014]
New assay may enable blood test of concussions/... [Published Medical Device Daily - Mar 18 2014]
New MRI can 'see through' metal screws after hi... [Published Medical Device Daily - Mar 15 2014]
Venaxis obtains positive top-line results for A... [Published Medical Device Daily - Mar 13 2014]
Karl Storz launches Flex-Xc Flexible Uretero-Re... [Published Medical Device Daily - Mar 13 2014]
Financings roundup: Med-tech hits a daily doubl... [Published Medical Device Daily - Mar 12 2014]
Corindus launches feasibility study to treat pa... [Published Medical Device Daily - Mar 11 2014]
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