Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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5. Check-Cap partners with GE to dev indigestible X-ray screening capsule
Check-Cap said yesterday it inked a development and manufacturing validation deal with GE Healthcare for integrating X-ray source production and assembly into Check-Cap’s indigestible capsule designed for colorectal screening.
The deal comes with the possibility for collaboration on the execution of a high-volume manufactuing facility and distribution of the Check-Cap system after completion of the initial deal, according to Israel-based Check-Cap. Read more
4. Endologix releases Q2, updates on Nellix discussions with FDA
Endologix on Wednesday released 2nd quarter earnings and updated on its discussions with the FDA over its Nellix system for treating abdominal aortic aneurysms, saying the agency is requesting additional information and may need an Advisory Committee Panel before it can obtain approval.
The company said that without a required panel, it is hopeful it will receive premarket approval from the FDA for the device in the 1st quarter of 2017. With a required panel, the company expects approval some time in the 3rd quarter of 2017. Read more
3. TransEnterix sees light on Q2 release, shares tick up
TransEnterix hasn’t had the best luck in 2016, with the FDA denying its 510(k) clearance submission in April and shareholders suing the company in June over the nixed project, but things are looking up for the robotics company with the release of 2nd quarter earnings that beat the street and sent shares up nearly 7%.
The Research Triangle, N.C.-based company reported losses of $80.1 million, or 70¢ per share with operating expenses of $80.7 million for the 3 months ended June 30. Read more
2. FDA releases updated draft guidance on 510(k) modification submissions
The FDA today released draft guidance providing updated recommendations for manufacturers on when to submit 510(k) applications for modifications to devices currently on the market.
The recommendations cover how manufacturers should consider the risk of device modifications when determining whether they need to submit a new 510(k) application, and will replace guidance that is 19 years old. Read more
1. Johnson & Johnson wins 5-year, $60m supply DoD contract
Johnson & Johnson’s Health Care Systems won a $60 million 5-year contract deal with the U.S. Department of Defense to supply dental and medical equipment.
The money comes from a fixed-price, indefinite-delivery/indefinite-quantity contract with no option periods. The contract was a competitive acquisition, and J&J was 1 of 121 responses received, according to a government release. Read more
The post MassDevice.com +5 | The top 5 medtech stories for August 5, 2016 appeared first on MassDevice.
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