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Bayer Healthcare’s Essure female contraceptive is facing new FDA scrutiny in the wake of a citizen petition alleging data integrity breaches on the part of the manufacturer. Read More
Australia’s Therapeutic Goods Administration has updated the procedures for determining when fees can be reduced for audits and conformity assessments of medical devices. Read More
The i-Stat system measures the amount of hormone hCG in the blood stream and does not rely on urine, making it more attractive for emergency settings, company says. Read More
The FDA has approved AcuFocus’ KAMRA inlay, the first implantable device to help improve vision in patients with presbyopia who have not had cataract surgery. Read More