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Fdanewsdevicedailybulletin

April 24, 2014

Vol. 11 No. 81

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Ohio Groups Partner to Speed Biomedical Innovation

Austen BioInnovation Institute of Akron is teaming up with Cleveland’s Nottingham Spirk to hasten biomedical innovation in Ohio, the groups announced Monday. Read More

Boston Scientific Kicks Off Trial of Next-Gen Acuity and Reliance ICD Leads

Results of the trial will be used to support FDA approval. Read More

HC Refuses to Quash Government Order for Procuring Coronary Stents

Observing that the government can impose stringent technical requirements to provide best possible medical devices for the purpose of public health programs, the Bombay High Court refused to quash and set aside bids issued by the state to procure coronary stents. Read More

Quidel Receives FDA Clearance for Lyra Molecular PCR Assay for Detection of Infections From Pyogenic Streptococcus Group A and C or G

Quidel has received clearance, via the De Novo Request process, from the FDA to market its Lyra Direct Strep Assay, a multiplex real-time PCR assay. Read More

Ethicon Fights Plaintiffs' Remand Bid in Pelvic Mesh Cases

Johnson & Johnson’s Ethicon subsidiary asked a federal judge yesterday to block a bid to send a group of pelvic mesh product liability cases back to a state court in Philadelphia. Read More

Rwanda: New Quick TB Tests Out Next Month

To contribute to the reduction of tuberculosis in the country, the Ministry of Health is set to introduce a new quick-testing method for the disease that will avail results within a week. Read More

Westtown Students Create Robotic Hand for 8-Year-Old

Now, the 8-year-old from Wilmington, who plays lacrosse and golf, swims, skis and bounces on his friend’s trampoline until the two of them collapse, is getting a bit of bionic help from engineering students at the Westtown School in Chester County. Read More

China Device Regulations Overhaul to Take Effect June 1

The People’s Republic of China has announced major revisions to its Regulation on the Supervision and Administration of Medical Devices that will likely affect every medical device manufacturer doing business in China. Read More