The Medical Device Business Journal — Medical Device News & Articles | MassDevice
Boston Scientific Corp. (NYSE:BSX) launched a new global trial of its next-generation Omega bare-metal stent by enrolling its first patient in Latvia.
The trial will include up to 328 patients across 40 sites in the U.S. and Europe in efforts to determine the safety and effectiveness of the med-tech giant’s bare-metal stent in a single-arm prospective study of coronary artery disease patients.
Oct 5, 2011
MASSDEVICE ON CALL — The newest version of the iPhone, known as the 4S, was unveiled this week with features that are likely to be a step up or tech-savvy health care providers.
While it looks just like the previous generation, the 4S has upped the ante with double the processing power and a camera with six times the resolution of its predecessor
Brainsway Ltd.’s (PINK:BRSYF) transcranial magnetic stimulation device won Israeli Ministry of Health approval to treat major depression, bipolar disorder and negative impairment in schizophrenia patients.
The approval clears Jerusalem-based Brainsway to sell the non-invasive TMS device, which delivers brief magnetic pulses to the brain, to four medical centers specializing in mental disorders.
MASSDEVICE ON CALL — Reps. Erik Paulsen (R-Minn.) and Jim Gerlach (R – Pa.) went to bat for medical device makers, urging that the 2.3 percent excise tax set to go into effect in 2013 will hinder innovation in the field.
Paulsen and Gerlach penned a statement on the med-tech levy, saying that the measure will be directly responsible for some 43,000 lost jobs and put American global competitiveness in peril.
Shares of Edwards Lifesciences (NYSE:EW) lost nearly 7 percent today, after a Centers for Medicare & Medicaid decision to review its coverage policy for a type of replacement heart valve.
CMS said it plans to go over "evidence pertaining to the health outcomes attributable to the use of [transcatheter aortic valve replacement], including evidence on the experience and qualifications of physicians and facilities that affect these outcomes."
The FDA’s circulatory system devices panel has Medtronic Inc. (NYSE:MDT), AtriCure Inc. (NSDQ:ATRC) and Cook Medical in its sights for panel review next month.
Medtronic and AtriCure are both hoping to get the panel’s nod for cardiac ablation devices, and Cook is working toward clearance for its drug-eluting stent.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2011-N-0002]
Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory Committee.
Karen Sandler, the woman in charge of open-source software company GNOME, has been fighting to view the source code for her Medtronic (NYSE:MDT) EnTrust cardioverter since she received the implant in 2008.
Medtronic Inc. (NYSE:MDT) launched a pivotal trial in support of a European regulatory win for its Engager transcatheter aortic valve implantation system.
The trial will include 150 people with severe aortic stenosis, a condition where the aortic valve doesn’t open fully and blood isn’t properly pumped out of the heart.
Study will evaluate new therapy option for patients suffering from valvular heart disease
