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Positive data from a recently published study has backed the use of Inivata's liquid biopsy platform for detecting T790 mutations in lung cancer patients unable to undergo tissue biopsies.
Latest From Clinical Trials
Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial initiations, completions and suspensions each month. Over the last month, 31 new trials started, 25 trial were completed, one trial was "reinitiated," and six trials were terminated or suspended, according to meddevicetracker.
Japan’s “fast-break scheme” is coming soon and will be the country’s fourth procedure for accelerating the approval of important medical devices.
This edition of device debuts highlights a wide variety of innovative devices introduced into commercial markets since the beginning of March, including a new stent for side-branch coronary interventions, an assay that identifies which breast-cancer patients do not need chemotherapy, a full ankle prosthesis, improvements to a negative-pressure wound therapy system, and a robotic system that helps paralyzed people learn to walk again.
A digital video game developed by Akili Interactive Labs for treating cognitive disorders has demonstrated in a pilot study its ability to improve cognitive control test scores of neurotypical children and children with sensory processing dysfunction (SPD). The company is also anticipating a market launch of the device for pediatric attention deficit hyperactivity disorder in 2018.
Results of the LATERAL trial presented at the recent ISHLT conference show Medtronic's HVAD can be implanted safely through a thoracotomy procedure instead of the standard sternotomy approach, which is far more invasive. At the same meeting, subset data from the ENDURANCE trial confirms that the sickest heart-failure patients treated with HVAD have similar outcomes as less sick patients, and results of the ENDURANCE Supplement show that blood pressure management minimizes the risk of stroke with HVAD.
A letter to Abbott's customers states that the company will restrict its Absorb bioresorbable stent to registries in Europe while it investigates possible safety issues flagged in clinical trials.
Preliminary two-year results from the randomized AIDA trial comparing Abbott's Absorb GT1 BVS and Abbott's Xience Prime drug-eluting stent found patients treated with Absorb were almost four times as likely to develop a stent thrombosis. The results are the latest in disappointing clinical news for the bioabsorbable scaffold.
MDxHealth has released results from a prospective study demonstrating biomarkers from its Confirm MDx prostate cancer test identifies men at increased risk of prostate cancer recurrence. The test could help urologists monitor therapy response to improve the personalized treatment of castration resistant prostate cancer (CRPC).
Two-year results of the ABSORB III trial, comparing Abbott's Absorb bioresorbable stent to its Xience metal drug-eluting stent, showed a higher risk of target vessel failure with Absorb, prompting the US FDA to send-out a "Dear Doctor" letter reiterating the importance of following the recommended implantation technique.
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