Postmarket Safety

NIST Issues Cybersecurity Framework With New Focus on Supply Chain Risk

The National Institute for Standards and Technology released a new cybersecurity framework that focuses on supply chain risks and risk management. Read More

Abbott Issues Firmware Update for Implantable Cardiac Devices

Abbott released a firmware update for certain high-voltage implantable cardiac devices that strengthens their security and adds a vibrating battery performance monitor. Read More

FDA Restricts Distribution of Essure to Establish Additional Safeguards

The FDA ordered a restriction on marketing and distribution of Bayer’s permanent birth control device Essure amid fears that patients were not given enough risk information to make informed decisions about the product. Read More

FDA Issues Advisory on Neurovascular Embolization Coils

The FDA sent a letter to health care providers warning of the potential for increased image voids when using magnetic resonance angiography (MRA) imaging for follow-up of certain post neurovascular embolization coil procedures. Read More

FDA Warns Olympus, Fujifilm, Pentax for Failing to Comply With Postmarket Surveillance Order

The FDA issued warning letters to duodenoscope manufacturers Olympus, Fujifilm and Pentax for failing to comply with federal law… Read More

TGA Issues Alert for Blood Treatment Device

Australia’s Therapeutic Goods Administration is investigating a safety concern involving Therakos’ Cellex photopheresis system. Read More

Gottlieb: FDA to Continue Analyzing Safety of Bayer Birth Control Device

FDA Commissioner Scott Gottlieb said the agency is evaluating thousands of adverse event reports for Bayer’s permanent birth control device Essure received in the past year. Read More

Cybersecurity Researchers Find Medical Imaging Devices at Risk

Cyberattacks on medical imaging devices such as CT and MRI devices are poised to become a major challenge for device manufacturers, according to researchers at Ben Gurion University of the Negev, Israel. Read More

Regulatory Hurdles for Design Changes Stall BSI’s Market Comeback

Boston Scientific is facing regulatory hurdles with its proposed manufacturing process and design changes to bring its transcatheter aortic valve back to the U.S. and EU markets. Read More

FDA Flags Spate of Repeat Nonconformities at Zimmer Biomet

In a rare exception to the FDA’s normal practice, the agency posted a Form 483 flagging several GMP and MDR nonconformities — most of which are repeat observations — at a Zimmer Biomet medical device manufacturing facility in Indiana. Read More