FDAnews Device Daily Bulletin

The FDA will likely see its budget reduced by $294 million if across-the-board cuts to federal programs go into effect on Jan. 2, 2013, as currently planned; the cuts are needed to comply with a congressional mandate to reduce the federal deficit.

Medical devicemakers should report all adverse events in premarket clinical trials and any device deficiencies that might lead to a serious adverse event (SAE), according to the Global Harmonization Task Force’s (GHTF) final guidance on reportable events.

In a report released Thursday, the FDA outlined a four-step plan to intensify its postmarket medical device surveillance system.

NeuroSigma has obtained European approval for its Monarch external Trigeminal Nerve Stimulation (eTNS) system.

Say “ultrasound,” and most people think of cloudlike images of a baby’s heart, limbs or face inside the mother’s womb.

When podiatric surgeon Scott Roman designed a new device for surgical repair of proximal interphalangeal joint flexion deformity, the often painful condition known as “hammertoe,” a professional associate urged him to contact Patrick Mullaney for assistance in launching the device.

Medical equipment maker Opto Circuits said it has received approval from India’s health regulator for a medical device for heart patients, following which it has launched the product in the market.

The medical-devices industry has been slow to embrace the sustainability trend, according to companies working in the sector.