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The promising new hypertension treatment known as renal denervation is safe in the short to medium term, but more safety information is needed before conclusions can be drawn about its long-term benefits versus standard care in treating treatment-resistant hypertension. Read More
The U.S. Food and Drug Administration’s new custom device exemption does not apply to 510(k)-cleared devices that are modified but still retain their original intended use and could be clinically studied, the agency clarifies in a draft guidance. Read More
Devicemakers must include information on potential pediatric use in most new device submissions under a U.S. Food and Drug Administration final rule that takes effect April 10. Read More
Manufacturers of partial hip, knee and shoulder implants reclassified from Class IIb to Class III may use summary technical reports as interim evidence for inclusion of their devices in the Australian Register of Therapeutic Goods, the Therapeutic Goods Administration says. Read More
Russian regulators are struggling to create guidance that will implement device registration rules that took effect in January 2013, but have yet to be fully enacted. Read More
India’s Ministry of Health and Family Welfare said it will create a Medical Technology Assessment Board to evaluate existing and new technologies and accelerate production by local devicemakers. Read More
Sponsors of clinical trials in India must inform enrollees during videotaped informed consent sessions about potential payments resulting from adverse events, a draft guideline says. Read More
The FDA and American Glaucoma Society will hold a workshop to discuss clinical trial design and safety parameters for minimally invasive glaucoma surgery. Read More
An institutional review board at one of Chicago’s major hospitals was handed an FDA warning letter for a slew of violations — many cited previously — in a medical device clinical trial. Read More
A Kentucky hospital has agreed to pay $16.5 million in restitution to resolve allegations it billed Medicare and Medicaid for cardiac implants that were not medically necessary, in violation of the False Claims Act. Read More