I tried hard to find a topic other than the coming medical device excise tax to write about, however, either my brain didn’t have any more room to fit another topic or there’s just not that much else going on in the medical device industry (which is much less likely). I was also hesitant to write the column because, unlike with the web, there is a period of time that passes from the moment I complete the column until the time it is published and mailed where the content is out of my hands while outside forces can wreak havoc on the topic and the timing of its appearance.
Many medical device component manufacturers have to adjust their product formulations to meet growing market demand for protein-free alternatives to natural rubber and natural rubber latex (NR/NRL). As simple as this may sound, this change not only requires the use of unfamiliar raw materials, but also requires new processes and a certain amount of trial and error before manufacturers discover the best NR/NRL alternatives for their formulations. One thing they can agree upon is that not all NRL alternatives are created equally.
It’s not the journey, it’s the destination. In the case of interventional cardiovascular devices, both the journey and the destination are vital. These devices need to navigate the tortuous pathways of the vasculature in order to access and treat complex distal lesions. Getting there isn’t always easy.
When a manufacturer picks up a cardiovascular device, they literally hold someone’s life. There is no room for flaws in the quality of this product, or any other in the cardiovascular realm. These devices are shrinking, while becoming increasingly advanced—more intricate parts achieve more complex functions, within a surface area that leaves only enough space for perfection. So the case has never been greater for quality assurance. Conducting risk analysis through variation analysis software can satisfy it.
High Levels of Estradiol, Progesterone During Pregnancy Associated With Increased Risk for HR-negative Breast CancerOctober 18, 2012 3:00 pm | by AACR | News | Comments
Pregnancy hormones linked to HR-negative tumors diagnosed before age 50. IGF-1 and testosterone associated with HR-positive disease. ANAHEIM, Calif. — Increased concentrations of the pregnancy hormones estradiol and progesterone were associated with an increased risk for hormone receptor-negative breast cancer diagnosed before age 50, according to the results of a nested case-control study presented at [...]
Sunshine Heart's Feasibility Study Data to Be Presented at 2012 Transcatheter Cardiovascular Therapeutics ConferenceOctober 18, 2012 2:15 pm | by The Associated Press | News | Comments
Sunshine Heart, Inc. (NASDAQ: SSH) (ASX: SHC), a global medical device company focused on innovative technologies for moderate heart failure, today announced that its flagship C-Pulse Heart Assist System will be featured in two clinical presentations at the 24th annual Transcatheter...
Molex Expands Global Medical Electronics Market Capabilities with Acquisition of Affinity Medical TechnologiesOctober 18, 2012 12:40 pm | by Molex Incorporated | News | Comments
Molex Incorporated, global manufacturer of complete interconnect solutions, announced today it has acquired Affinity Medical Technologies LLC, based in Costa Mesa, Calif. Affinity Medical Technologies specializes in designing and manufacturing custom medical interconnect products.
Fluke Biomedical announced today the release of the new Training Tablet. An Apple iPad® loaded with over 80 training modules, application notes, whitepapers and operational guides, the new training tool is the perfect companion for medical device quality assurance and safety professionals.
Medtronic, Inc. (NYSE: MDT), today announced the Japanese regulatory approval and launch of the Advisa DR MRI™ SureScan™ pacing system. The Advisa MRI system is the first and only MR-Conditional pacemaker available to patients in Japan, the world’s second largest market for medical devices.
VuCOMP lands FDA approval for its 2nd-generation M-Vu computer-aided detection system for automatic analysis of digital mammography images. Medical imaging analysis devices maker VuCOMP touted FDA premarket approval for its new M-Vu system for helping radiologists detect breast cancer earlier. The Version 2 M-Vu system's new indication allows the company to market its devices as an computer-aided detection adjunct to digital mammography. News Well, Breast Cancer, Food & Drug Administration (FDA), Imaging, Mammography, Pre-Market Approval (PMA), Regulatory/Complianceread more
MOCON Inc., the world’s leading manufacturer of permeation instrumentation, now is offering the ability to increase throughput of oxygen testing for rigid packages. A new RACK-6™ conditioning system...
Methods Machine Tools, Inc., a leading supplier of innovative precision machine tools, automation and accessories, has introduced FEELER FT-Series High Performance CNC Turning Centers featuring a new all-boxway design to significantly increase cutting capacity.
At IMTS 2012, Mahr Federal unveiled a revolutionary way to measure surfaces. Mahr Federal introduced a new Android App that lets users measure common surface roughness parameters using their Smartphones...
element14, the first collaborative community and electronics store for design engineers and electronics enthusiasts and a part of global electronics distributor Premier Farnell, today announced its continued partnership...
Risk for death from colorectal cancer reduced by 17 percent. Allergy-related immune system responses could be potential mechanisms. ANAHEIM, Calif. — People with both hay fever and asthma — but not people with only one of these two conditions — experienced an approximately 17 percent lower risk for dying from colorectal cancer, according to data [...]