FDAnews Device Daily Bulletin

Premarket submissions for internet-connected medical devices should include cybersecurity risks considered during the product design, established cybersecurity controls and a traceability matrix linking the controls to the risks they mitigate, according to a draft guidance.

EU lawmakers seemed lukewarm, at best, on the idea of subjecting the riskiest medical devices to a U.S.-style premarket approval mechanism during a May 29 debate by members of the Committee on the Environment, Public Health and Food Safety.

A new Indian mental health bill expands rights granted to the mentally ill in the country; among those rights is the right to receive anesthesia with electric shock therapy.

Japan’s Ministry of Health has decided to cover breast implants for women who have had mastectomies to remove cancer.

NBC News highlights the case of one patient who underwent a robotic hysterectomy – with an unbelievable complication – in order to question whether robotic surgery is really safe.

Two Irish medical devicemakers have been chosen to participate in a European Commission project to develop new ways to manufacture medical devices.

Edwards announced impressive durability results for its bovine heart valves.

A Belgian study claims that clinical trial results of renal denervation could be misleading.