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The FDA is trying to address barriers to more widespread use of over-the-counter (OTC) hearing aids, including cost, access and state and federal regulations, through a proposed rule and draft guidance published today in the Federal Register. Read More
It can be faster in some cases to make use of the FDA’s 510(k) marketing clearance pathway than to apply for Emergency Use Authorization (EUA), a medical device regulatory consultant says. Read More
Marlborough, Mass.-based obstetrics-gynecological device company, Hologic, is expanding its portfolio of laparoscopic devices through a $160 million purchase of Bolder Surgical, a privately held company in Louisville, Colo., that specializes in vessel-sealing surgical devices. Read More
In a Complete Response Letter (CRL) to United Therapeutics, the FDA declined to approve the company’s Tyvaso DPI (treprostinil) drug-device combination for improving exercise capacity in patients with pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. Read More
Australia’s Therapeutic Goods Administration (TGA) has offered advice to devicemakers in a new guidance about how to apply for consent to import, supply or export a medical device that doesn’t comply with the agency’s Essential Principles for safety and performance. Read More
Many device manufacturers are guilty of engaging in practices that leave their software components open to computer attack, a software security professional said. Read More