CardiAQ, Edwards, acquire, acquisition, Fortis, TMVI, mitral valve replacement
Feature | Heart Valve Technology

Edwards Lifesciences Corp. announced that it has agreed to acquire CardiAQ Valve Technologies Inc., a privately held company and developer of a transcatheter mitral valve replacement (TMVR) system.

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sentraheart lariet, LAA occlusion, FDA safety alert
Feature | Left Atrial Appendage (LAA) Occluders

The U.S. Food and Drug Administration (FDA) is alerting healthcare providers and patients of reports of patient deaths and other serious adverse events associated with the use of the Lariat Suture Delivery Device used for minimally invasive surgical closure of the left atrial appendage (LAA)

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21st Century Cures Act, H.R. 6, HR-6, HR 6, medical device innovation
Feature | Cardiovascular Business | Dave Fornell

The U.S. House of Representatives July 10 passed its version of the 21st Century Cures Act (H.R. 6), designed to improve the U.S. healthcare innovation infrastructure. It was approved in a bipartisan vote of 344-77. The bill calls for providing resources to researchers working on next-generation medical devices and therapies. The legislation is aimed at addressing concerns that U.S. healthcare innovation is lagging behind the rest of the world due to large amounts of time-consuming and expensive regulatory oversight requirements that some feel are stifling innovation and the ability of startup companies to bring new products to market.

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platelet-like particles, PLPs, clotting, substitute, Carver, Lyon, NIBIB
Feature | Antiplatelet and Anticoagulation Therapies

Researchers have created tiny gel particles that can perform the same essential functions as platelets. The particles could one day be used to control excessive bleeding following traumatic injury, or in individuals with impaired clotting due to an inherited condition or as a result of certain medications or chemotherapy.

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wearable sensors, Verizon, fitness trackers, smart watches
Feature | Wearables

Wearable sensors are expected to play a big role in healthcare in the coming years, according to Verizon, as data from these devices are integrated into patient electronic medical records. They offer a big-picture view of a patient's health, beyond a yearly checkup. These devices are also expected to play a major role as healthcare organizations look for new ways to engage patients electronically to meet new federal health IT requirements.

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Technology

Opsens Inc. announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the OptoWire and OptoMonitor, its products developed to measure fractional flow reserve (FFR). This measure is used to optimize the diagnostic and guide the treatment of patients with coronary heart disease.

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News | Cardiovascular Business

The Centers for Medicare & Medicaid Services (CMS) and the American Medical Association (AMA) announced efforts to help physicians prepare for the nationwide switch from ICD-9 to ICD-10 ahead of the October 1 deadline. In response to requests from the provider community, CMS is releasing additional guidance that will allow for flexibility in the claims auditing and quality reporting process as the medical community gains experience using the new ICD-10 code set for medical diagnoses and inpatient hospital procedures.

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News | Information Technology

Health data security and patient engagement are top priorities for the nation's hospitals, according to results of the 17th annual HealthCare's Most Wired Survey. The annual survey was released by the American Hospital Association's Health Forum and the College of Healthcare Information Management Executives (CHIME).

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St. Jude Medical, OCT, ILUMIEN III, IVUS, angiography, PCI
Feature | Intravascular Imaging

St. Jude Medical, Inc. announced the launch of the ILUMIEN III clinical trial on June 30. ILUMIEN III is a prospective, international, randomized trial evaluating the clinical benefits of the company's optical coherence tomography (OCT) guidance during stent implantation. The study will compare OCT-guided stent implantation to implantation guided by intravascular ultrasound (IVUS) or angiography alone, diagnostic tools that offer less resolution than OCT during intravascular assessments and percutaneous coronary intervention (PCI).

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News | Ventricular Assist Devices (VAD)

During an event with Massachusetts Gov. Charlie Baker in June, Abiomed announced a major expansion of its U.S. headquarters in Danvers, Massachusetts, and the creation of approximately 100 new, local jobs.

Home July 09, 2015
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News | Cardiovascular Business

Mercom Capital Group llc, a global communications and research firm, released its report on funding and mergers and acquisitions (M&A) activity for the Healthcare Information Technology (IT)/Digital Health sector for the second quarter of 2015. The comprehensive report covers deals of all sizes across the globe.

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Feature | Cardiovascular Business

Sorin S.p.A. and Cyberonics Inc. unveiled LivaNova as the name of their combined company, effective at the close of their proposed merger.

Home July 08, 2015
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News | Computed Tomography (CT)

The Society for Heart Attack Prevention and Eradication (SHAPE) submitted a letter to the U.S. Preventive Services Task Force (USPSTF) strongly supporting the use of coronary artery calcium to assess an individual's risk of heart attack.

Home July 08, 2015
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C.R. Bard, LEVANT 2 results, Lutonix 035 DCB, drug coated balloon, PTA
Feature | Drug-Eluting Balloons

C.R. Bard Inc. announced the publication of results from the LEVANT 2 study in the June 24, 2015, online issue of The New England Journal of Medicine. Results from LEVANT 2 demonstrated superior primary patency for the Lutonix 035 drug coated balloon percutaneous transluminal angioplasty (PTA) catheter over standard PTA, as well as safety consistent with standard PTA balloons. The Lutonix 035 DCB is an angioplasty balloon coated with a therapeutic dose of the drug paclitaxel, and also utilizes standard mechanical dilatation of the vessel to restore blood flow for patients with peripheral arterial disease (PAD) in the femoropopliteal arteries.

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Technology

Masimo announced the CE Mark and full market release of MightySat Rx fingertip pulse oximeter for clinical use in CE countries. The device uses Masimo’s SET Measure-Through Motion and Low Perfusion pulse oximetry.

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