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FDA News Device Daily Bulletin
- Insight Gets 483 Citing Complaint Handling
Insight Instruments received a Form 483 with several references to its handling of complaints, including ones involving difficulty removing a mini-light from patients’ eyes.
- Allergan Drops Suit Challenging FDA’s Off-Label Enforcement
The device industry may have lost its best shot at challenging how the FDA regulates off-label use when Allergan agreed to drop its First Amendment lawsuit seeking the right to tell physicians how to safely use a product off label.
- K2M’s Anterior-Lumbar Stabilization System Cleared
K2M has received 510(k) clearance for its Chesapeake anterior-lumbar stabilization system, a device that uses an anterior approach to stabilizing the spine.
- Scientists Make Leap Forward in Early Detection for Alzheimer’s, Cancer
Scientists at the UK’s National Physical Laboratory have developed a new strategy for quicker and more precise detection of biomarkers — proteins which indicate disease. The work could pave the way for new tools to detect early stages of Alzheimer’s and cancer at the molecular level.
- Wireless-Life Sciences Alliance Submits Recommendations to FCC, FDA
In a recent filing with the Federal Communications Commission (FCC) and the Food and Drug Administration (FDA), the Wireless-Life Sciences Alliance makes four sets of policy recommendations for federal agencies as they craft guidelines and regulations for wireless health technologies.
- Luminex MAGPIX System More Cost Effective and Efficient
Luminex Corporation Wednesday announced that initial results from a study conducted at the NMI Natural and Medical Sciences Institute at the University of Tubingen in Germany demonstrate that its MAGPIX system provides more cost effective and efficient results than a conventional microtiter plate based ELISA method.
- BARRX Medical Signs Distribution Agreement With Medico’s Hirata
BARRX Medical, Inc., a world leader in endoscopic treatment solutions for treating precancerous lesions of the esophagus as well as other chronic gastrointestinal diseases, announced Wednesday that the company has signed an exclusive agreement with Medico’s Hirata for distribution of the HALO Radiofrequency Ablation System in Japan.
- Alliance to Push for Medical Innovation
Worried that pressure to control health care costs will lead to lower prices for drugs and medical devices, making it less attractive to invest in life sciences companies, a group of venture capitalists and entrepreneurs is set to launch a national alliance Wednesday to promote policies and regulations that favor US medical innovation.
- Surgery for Obese Would ‘Save Millions of Pounds’
Offering more obese patients weight-loss surgery would save the economy hundreds of millions of pounds each year, leading surgeons said Wednesday.
- CDRH Touts Proposed 510(k) Changes as Good News for Device Industry
CDRH is trying to sell devicemakers on suggested changes to the 510(k) process, saying the changes would increase regulatory predictability.
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