FDA and Health Canada Approve OneTouch Vibe Plus Insulin Pump December 20, 2016 The device is an insulin pump and a glucose monitoring system. Read More
Anika Therapeutics Scores CE Mark for Tendon-Injury Treatment December 20, 2016 Orthovisc-T is administered via injection into the site of injury. Read More
Foundation Medicine Garners FDA Approval for Companion Device for Rubraca December 20, 2016 The device is a tissue-based, genomic assay. Read More
FDA Grants Marketing Clearance to SalutarisMD’s RBS System December 20, 2016 The SMD-Sr90-DA RBS device is indicated for episcleral brachytherapy. Read More
$11.5 Million Raised for EU Device Startups December 19, 2016 MD Start II will continue to incept, finance, and develop startup companies. Read More
EU Grants Marketing Approval to HiberGene December 19, 2016 The test can detect C. difficile in stool samples within an hour. Read More
Circulatory Technology Hit With Form 483 for Improper Reporting, Evaluations December 19, 2016 The company failed to submit an MDR report within 30 days of becoming aware of a device that had malfunctioned. Read More
FDA Announces Unchanged Final Guidance for IDEs for Neurological Diseases December 19, 2016 The guidance aims to help weigh the risks of medical devices for neurological conditions. Read More
HAS Grants Reimbursement to Theraclion December 16, 2016 The study has been approved to commence in 12 hospitals across France. Read More
FDA Seeking Feedback on Patent And Care-Partner Connection December 16, 2016 The FDA has set a goal for 90 percent of CDRH employees to interact with patients as part of their job duties. Read More
MDUFA IV Would Raise Fees, Reduce Time for Decisions December 16, 2016 The FDA has agreed to cut time-to-decision goals for 510(k)s from 124 to 108 days. Read More
Manufacturers Need Cyber Risk Assessment Team, Framework December 16, 2016 Manufacturers also need to develop a comprehensive risk assessment framework. Read More