Sapheon Inc. announced today that it submitted the first module of the pre-market approval (PMA) application for the VenaSeal® Sapheon Closure System to the U.S. Food and Drug Administration (FDA). The submission places Sapheon on track for timely FDA review and expected product launch in the first half of 2015.
The CE marked TriGuard is the only device designed to cover all three aortic cerebral branches to minimize the risk of cerebral damage during Transcatheter Aortic Valve Replacement (TAVR) and other cardiovascular procedures. It is the only system designed for placement via one of two femoral artery access ports.
A case study released on the anniversary of medical device giant Elekta's work with Licensale.com revealed that just one year after its launch, Arazy Group's unique, online registration platform is a revolutionary regulatory asset for medical device manufacturers of all sizes.
While all electronic products must comply with electromagnetic compatibility (EMC) requirements, EMC evaluation of medical devices is expanded to include product safety. This step-up is understandable as human health and life are frequently dependent on medical devices in a healthcare setting.
An FDA panel yesterday recommended that the FDA reclassify membrane lung for long-term pulmonary support systems, or so-called extracorporeal membrane oxygenator circuits and accessories, from the highest-risk Class III category to the less burdensome Class II, with special controls.
Federal health regulators have approved the first permanent implant to treat men's urinary problems caused by an enlarged prostate. The Food and Drug Administration says it approved the Urolift system to relieve low or blocked urine flow in men age 50 or older.
FDA/American Gastroenterological Association (AGA) Co-sponsored Public Workshop: Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Metabolic Diseases, October 17-18, 2013September 12, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments
The Food and Drug Administration (FDA) is announcing the following public workshop entitled "Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Metabolic Diseases: How to Estimate and Reward True Patient-Centric Value in Innovation.”
Major contractors hooking up the internal plumbing of President Barack Obama's health care law projected confidence Tuesday that they will be ready to go by an Oct. 1 deadline, even though the system is still being tested. With just three weeks to go before new state health insurance markets launch, efforts are ongoing to reliably link up government agencies, the markets themselves and private health plans.
In a draft guidance document, FDA has placed its summary of ideas regarding biocompatibility and possible changes that could eventually replace FDA G-95 Blue Book Memorandum #G95-1 on biocompatibility. The draft document has been out since April and is widely available, though it has not been formally released.
Meeting Announcement: October 8-9, 2013 Circulatory System Devices Panel of the Medical Devices Advisory CommitteeSeptember 9, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments
On both days the committee will discuss, make recommendations, and vote on devices indicated for use in patients with heart failure (HF). On October 8, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application regarding the expansion of indications supported by the BLOCK HF trial...
Despite widespread adoption by hospitals of surgical robot technology over the past decade, a “slapdash” system of reporting complications paints an unclear picture of its safety, according to Johns Hopkins researchers. In a report published online in the Journal for Healthcare Quality...
FDA regulators put their highest-risk Class I label on Siemens' (NYSE:SI) recall of more than 78,000 of its MicroScan Synergies plus and MicroScan rapID/S plus antimicrobial tests, warning that false test results could hinder patient care.
A new ASTM International standard will provide a consistent method for analyzing hip stems used in hip replacement surgery. The new standard, ASTM F2996, Practice for Finite Element Analysis (FEA) of Nonmodular Metallic Orthopaedic Hip Femoral Stems, was developed by Subcommittee F04.22 on Arthroplasty, part of ASTM International Committee F04 on Medical and Surgical Materials and Devices.
Innovative control technology offers medical professionals and technicians the potential to do much more with diagnostic imaging equipment. “A New Dimension in Diagnostics,” this issue's cover story, looks at intuitive controls for radiological applications.
Guy Francfort, vice president of sales and marketing for MEGA Electronics Inc., was a part of the staff written article, “Portability Is the Name of the Game.” He took time to present a full array of responses that were not able to be included in the article, so they are presented here.
Wet Platinum Premium Personal Lubricant has received Section 510(k) medical device approval from the U.S. Food and Drug Administration, which allows this 100% silicone, latex-friendly product to be marketed in interstate commerce as substantially similar to other legally marketed predicate products.
HeartWare International, Inc., a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that the U.S. Food and Drug Administration (FDA) has approved an IDE Supplement that allows HeartWare to commence enrollment in an additional patient cohort for ENDURANCE...
The FDA took issue with certain manufacturing processes at a Fresenius plant in Puerto Rico, handing the German medical healthcare company its 3rd warning letter this year. Following an April inspection, the FDA raised concerns about product labeling and complaint-handling processes at the blood bag manufacturing plant...
The FDA has made medical device cybersecurity a high priority, even as it stresses that there have been no reported incidents of malicious medical device hacks or of patients harmed by a security-related issue. But that assurance is based more on assumption than fact, experts say.
Canadian healthcare regulators approved InSightec's ExAblate ultrasound system, clearing the device for use against 2 different diseases. Health Canada granted ExAblate indication to break up benign uterine tumors and to alleviate painful symptoms of metastatic bone tumors.
Many medical device companies have long petitioned for a repeal of the 2.3% excise tax on U.S. sales, but analysts say medtech companies have already managed to absorb the tax without taking a hit to the bottom line or jacking up costs for consumers.
No, hyperbaric oxygen therapy (HBOT) has not been clinically proven to cure or be effective in the treatment of cancer, autism, or diabetes. But do a quick search on the Internet, and you'll see all kinds of claims for these and other diseases for which the device has not been cleared or approved by FDA.
Regulations for the Restriction of Hazardous Substances (RoHS) 2 impact the ways in which companies do business, especially in the medical device industry. On July 22, 2014, when a company places a CE mark on medical devices, they are confirming all appropriate measures were taken to ensure each product meets the RoHS 2 directive...
Covidien recalled some lots of its Monoject syringes after discovering a sterilization mishap and labeling problem. The issues affected 14 lots in shipments that went out to customers in the U.S. and Bermuda, the Mansfield, Mass.-based medical products giant said.
Medical device makers issued more than 400 recalls during Q2, 30% more than in the previous quarter. That's higher than reported for the last 5 quarter, according to a report by Stericycle ExpertRECALL. The recalls affected about 9.2 million units, a 50% decrease in the quantity of products affected in Q1.