| December 11, 2008 | News for medical technology professionals |
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 | Combined Expertise – Superior Protection
When an officer of an early stage technology company became embroiled in a wrongful employment practices charge, the allegation created a distraction from the company's implementation schedule. Click here to read how this situation illustrates the value of having a strong insurer as a risk management partner.
www.medmarc.com www.thehartford.com |
| Business & Market Trends |  |  |
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- Healionics gets $2.6M in funding
Healionics has secured $2.6 million from Bellingham Angel Group and other private investors that participated in a second round of funding. The company plans to use the money to conduct further studies on the efficacy of its product, a biocompatible material used in medical implants. The Seattle Times
(12/11)      
| Science & Health | | |
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| Emerging Technologies | | |
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- Access Scientific gets FDA approval for MicroAccess WAND
The FDA has approved Access Scientific's MicroAccess WAND, a safety introducer that allows doctors to put a catheter or a sheath into the peripheral vasculature during procedures. The clearance enables the clinical facilities to immediately use the device, said the company's CEO, Dr. Steve Bierman. HealthImaging.com
(12/10)
- FDA approves 3-D cardiac application from Viatronix
The FDA has given 510(k) clearance to Viatronix for its V3D-Cardiac module, which offers left-ventricle and coronary-analysis functions in a single application. The product can also be incorporated into PACS workstations and can evaluate cardiac CTC data in real time. HealthImaging.com
(12/10)
| Government & Regulatory | | |
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- Activists blast draft of disclosure rules in Mass.
Health care advocates criticized proposed regulations that would ban Massachusetts doctors from taking drugmakers' free meals and vacations but would not require them to report payments for research or clinical tests. The proposal would allow research payments to remain private in a bid to keep clinical trials in the state, Massachusetts Public Health Commissioner John Auerbach said. Boston Herald
(12/11)
- European Commission proposes new requirements for HIV tests
The European Commission has released a draft document recommending new requirements for HIV antibody/antigen combined tests. The changes are meant to reflect improvements in the sensitivity and performance of in vitro diagnostic device technology, the EC said. FDAnews
(12/10)
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FDA Inspections: What to Expect & What to Do -- Jan. 22, 2009, Orlando, Fla.
Every medical technology company will go through FDA inspections. Knowing what to expect, what FDA expects, common pitfalls, how to prepare employees and handle your response will help minimize the risks and improve the outcome of this unavoidable, sometimes challenging, experience. A leading regulatory attorney, industry experts and FDA investigators teach you the regulatory authority, typical procedures and best practices for managing an inspection. Register now. Medical Technology Learning Institute -- Education Beyond a Degree
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Enhancing Safety Risk Management
During this seminar on Jan. 20, 2009, in Orlando, Fla., you'll learn from FDA and industry leaders: - Causes of safety related recalls and how they could have been prevented
- What to include in your risk analyses, risk evaluation, risk control and post-production information
- Lessons from safety recalls and how they can be prevented
You'll also get a checklist with more than 130 common safety risk mitigation techniques commonly used to reduce risk. Get more information. Medical Technology Learning Institute -- Education Beyond a Degree
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