FDAnews Device Daily Bulletin

A working group comprised of FDA officials and various stakeholders is hoping to draft a “roadmap” to facilitate implementation of the agency’s unique device identifier (UDI) system, one FDAer said.

The FDA’s Cincinnati District Office issued a Form 483 to a maker of electroencephalogram application caps and related supplies due to missing validation and control procedures at its Eaton, Ohio, plant.

Lois Eskind died on Jan. 13, 2003, when she went into cardiac arrest moments after bone cement made by Synthes and its then-subsidiary Norian was injected into Eskind’s spine.

Medtronic announced it has received 510(k) clearance from the FDA for the Aquamantys3 BSC 9.1S Bipolar Sealer with Cutting, a new addition to the orthopaedic portfolio of the company’s Advanced Energy business.

Pneumonia kills more children than any other cause, according to the World Health Organization.

OncoSec Medical has received International Organization for Standards 13485 certification for the design and distribution of its electroporation devices.

As more emphasis is put on health technology and preventive care, new solutions promise to engage patients in taking control of wellness and disease prevention by using interactive, patient-oriented technology that works with data from physicians’ electronic health record systems.

Medical and industrial equipment maker Roper Industries is buying hospital software company Sunquest Information Systems for approximately $1.42 billion.