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Three years in the making, FDA has released a final guidance for medical device development tools that would allow developers to qualify their MDDTs and give medical device manufactures access to new tools that could help them prove safety and effectiveness of their products sooner.
Latest From Clinical Trials
Five-year mortality and major morbidity results from a large randomized trial run by the Veterans Affairs found no advantages to so-called off-pump "beating heart" coronary bypass graft surgery over traditional on-pump bypass surgery in which the patient is supported by a cardiopulmonary bypass machine.
The quality of studies used to support panel-track PMA supplement approvals need upgrading, as fewer than half were randomized, blinded or controlled and many relied on surrogate endpoints, says a study published in JAMA. In an accompanying editorial, former FDA commissioner Robert Califf, says it "raises concerns" that the US regulatory system has gotten "too permissive."
The TRILUMINATE trial will evaluate safety and effectiveness of its Tricuspid Valve Repair System for treating symptomatic moderate-to-severe tricuspid regurgitation. The device is similar to Abbott's successful MitraClip catheter-based device for treating mitral regurgitation.
US FDA has issued a temporary guidance to allow researchers to conduct "minimal-risk" clinical studies without consent and harmonize the agency's policy with the federal Common Rule for human subject research. The guideline implements a provision in the 21st Century Cures Act.
Scientists at the Institute of Cancer Research, London have developed a computer-based test that can identify women at high risk of relapsing from breast cancer within 10 years of diagnosis. The new image analysis tool looks at tissue samples taken as part of routine clinical practice and looks at the spatial distribution of immune cells in and around breast cancer, automatically.
Liquid biopsy company Angle plc, has reported positive results for its first large-scale study in Europe and the US using its Parsortix system to detect ovarian cancer. The study evaluated 400 patients for the detection of ovarian cancer in women with a high-risk pelvic mass.
Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial initiations, completions, and suspensions each month. This month's edition, covering the period between mid-June and mid-July, represents a wide variety of devices and companies, including many of the biggest medtech players.
Results of the MINDACT trial, which show that Agendia BV's MammaPrint 70-gene lab test can identify about half of the early-stage breast cancer patients who do not need chemotherapy, has led the American Society of Clinical Oncology to specifically recommend the test in its guidelines.
The US Medicare agency opened a national coverage analysis to reconsider coverage indications for implantable cardioverter defibrillators and received input from 35 individuals, organizations, and companies during the initial public comment period. The agency did not specify any particular issues or deficiencies that it wants to address by updating its coverage policy, but CMS has not reconsidered the national coverage policy on ICDs since a major coverage expansion was implemented in 2005.
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