This week's edition of Medtech Insight's Results Recap, the weekly round-up of major device trial-results, features just one entry - long-term data from a prospective, non-randomized, single-arm anatomic and clinical evaluation of chronic refractory angina patients implanted with Neovasc's Reducer at a single medical center as part of the first-in-human clinical study in 2005. The patients treated in the trial showed sustained improvement in angina class out to 12 years and all seven Reducers implanted in the study were still patent, with no signs of strut fractures, dislocation, thrombosis, or migration.
Roche aims to grow its diagnostics sales by mid to high single digits, said CEO of Roche Diagnostics Matt Sause. The company unveiled the Axelios synthesis and sequencing solution and discussed its “long-term commitment” to China, as well as its business strategy for the next five years.
Medtech Insight spoke with Hubert Martens, CEO of Netherlands-based neuromodulation company Salvia Bioelectronics, about the company’s innovative implant for treating chronic migraines, ongoing clinical trials and plans for US clinical trials and commercialization.
A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.
German Bionic’s new exoskeleton Exia helps healthcare practitioners, nurses, and other caregivers to lift and move patients by supporting muscle movement and reducing the risk of injury.
The FDA has stopped accepting data from two Chinese labs due to accuracy issues. Mid-Link and SDWH have been flagged for potentially falsified results and other misconduct. This decision, which follows months of discussions and warnings, emphasizes the FDA's commitment to ensuring data integrity in medical device submissions.