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Medical software that allows caregivers to noninvasively evaluate blood flow in patients with coronary artery disease gained marketing clearance from the FDA late last month. Read More
The Brazilian government is providing more clarity around a voluntary program that encourages public-private partnerships to expand access to affordable medical devices and diagnostics, but questions remain about the program’s transparency. Read More
Greiner Bio One Brasil Produtos ran afoul of the FDA after documenting design changes in informal meetings with informal notes, a recent warning letter shows. Read More
A government report shows increasing consolidation in the diabetes test strip market since stricter parameters on Medicare coverage of mail-order testing supplies took effect. Read More
Medical devices labeled as latex-free or lacking latex need updated labeling with the more scientifically accurate statement “not made with natural rubber latex,” according to FDA final guidance. Read More
Navilyst Medical, a subsidiary of AngioDynamics, received an FDA warning letter for quality issues at two facilities, including the sale of sterile product that contained foreign matter such as hair. Read More
Indian regulators are establishing quality manufacturing standards for medical devices and diagnostics to align the country’s requirements with international standards and move away from its system of regulating the products under rules designed for drugmakers. Read More
The FDA is ratcheting up safety controls on infusion pumps, mandating that developers of new pumps follow stricter requirements for design validation and verification and provide more detailed applications to address safety hazards associated with pumps used in the home. Read More
Devicemakers are breathing a collective sigh of relief following the Indian government’s decision to let companies affix labels with India-specific information on their products after they enter the country. Read More
The FDA is ordering manufacturers of power morcellators to add a black box warning to the devices and telling consumers the products are unsafe in almost all instances. Read More