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Top StoriesMedtronic Agrees To Settle 950 Lawsuits for $22M Over Its Infuse Bone Growth Product
As part of a settlement, Minneapolis-based MedTronic has agreed to pay $22 million to plaintiffs in an estimated 950 lawsuits filed over its Infuse bone growth product, but does not admit to any wrongdoing. An additional 750 cases brought by 1,200 plaintiffs are pending and more claims are expected to be brought. Read more… FDA to Hold Public Workshop on 3D Printing Medical Devices
In a May 19, 2014 Federal Register notice, FDA announces that it will hold a public workshop October 8-9, 2014, on the technical considerations of additive manufacturing, also known as 3-D printing. "The purpose of this workshop is to provide a forum for FDA, medical device manufacturers, additive manufacturing companies, and academia to discuss technical challenges and solutions of 3-D printing. " Read more… Boston Scientific Receives Subpoena Over Cognis, Teligen Defibrillators
Boston Scientific has received a subpoena from the U.S. Health & Human Services Department seeking information regarding its Cognis and Teligen line of implantable cardiac defibrillators (ICDs). In 2009, the company warned of problems in some 8,000 of the ICDs related to 15 cases of inappropriate shocks to patients. Read more… As First Lawsuits Are Filed Over Laparoscopic Power Morcellators, Sale of Alternative Symphion System is On The Horizon
The first federal lawsuit involving laparoscopic power morcellators was filed in the Eastern District of Pennsylvania against LiNA Medical on March 14, 2014 by the family of Donna Burkhart. The lawsuit alleges that the morcellator manufacturer failed to adequately warn surgeons of the risk of disseminating cancer following the use of the device, failed to design a safer "closed" system that would prevent the spread of cancer cells, and failed to act when studies revealed that disseminating cancer was occurring. Read more… FBI Warns That E-Health Records and Internet Connected Medical Devices Are Vulnerable to Cyber Attack
The FBI’s Cyber Division released a Private Industry Notification (PIN) on 8 April 2014 detailing in stark terms that healthcare records and medical devices are poorly defended against cyber intrusions. The problem is exacerbated by the looming 2015 deadline for transition to electronic health records (EHR) as envisioned by the Information Technology for Economic and Clinical Health Act (Public Law 111–5, 123 Stat. 115 (2009)). Read more… Increasing Antiobiotic Resistant Gram-negative Bacterial Infections Pose Serious Threats to Patients
Organizations like the World Health Organization and the U.S. Centers for Disease Control are offering a bleak assessment of our future ability to fight common infections as the antibiotic resistance of common Gram-negative bacteria continues to increase. Gram-negative bacteria (a description derived from the bacterium’s inability to retain the violet stain used to identify it under a microscope) have a relatively impervious outer membrane that helps the bacteria resist antibiotics. Read more… Latest Recalls/FDA Warnings
FDA Warns Sleep Drug Lunesta Can Cause Next-Day Impairment
The FDA is warning that the sleep aid Lunesta (eszopiclone) can cause next-day impairment of driving and other activities that require alertness. As a result, the FDA has decreased the recommended starting dose of Lunesta from 3 mg at bedtime to 1 mg at bedtime. 400,000 bottles of Generic Effexor and Antihistimine Cetirizine Recalled by Sun Pharma
India's largest drug manufacturer Sun Pharmaceutical Industries Ltd., is recalling nearly 400,000 bottles of its generic form of the anti-depressant Effexor (Venlafaxine) and the antihistamine Cetirizine because the pills fail to dissolve properly. J&J Stops Sale of Laparoscopic Power Morcellators Used in Fibroid Surgery
Amid concerns over the potential to spread undetected cancer beyond the uterus, Johnson & Johnson (J&J) has suspended the sale of its power morcellators until their role in fibroid treatment is better understood. Read more… 
FDA Proposes to Reclassify Transvaginal Mesh to Class III High-Risk Device
According to an FDA press release today, the FDA has proposed two orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP). If finalized, the orders would reclassify surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness of surgical mesh used to treat transvaginal POP. Read more... FDA Approvals
Jintronix Software Gets FDA Clearance As Rehab Therapy for Stroke Patients
Seattle-based Jintronix has announced that it received 510(k) clearance from the FDA for its rehabilitation software. Jintronix's system is a set of games and exercises designed for Microsoft's Xbox Kinect system to stimulate recovery in stroke victims. The Kinect's motion-sensing camera allows players to interact with what they see on the screen, providing immediate feedback for patients. Read more... FDA approves Zontivity to Decrease Risk of Heart Attack and Strokes Caused By Blood Clots
FDA has approved a new drug made by Merck & Co., Zontivity (vorapaxar), to decrease the formation of blood clots in patients with a previous heart attack or blockages in the arteries to the legs. Zontivity is an anti-platelet agent designed to decrease the tendency of platelets to clump together to form a blood clot. By decreasing the formation of blood clots, Zontivity decreases the risk of heart attack and stroke. Read more... FDA Approves Zykadia for Late-Stage Lung Cancer
The FDA has granted approval to Zykadia (ceritinib) to treat patients with late-stage (metastatic) non-small cell lung cancer (NSCLC). Zykadia is an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor that blocks proteins that promote the development of cancerous cells. It is intended for patients with metastatic ALK-positive NSCLC who were previously treated with crizotinib, the only other approved ALK tyrosine kinase inhibitor. Read more... For more news see Alerts
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