Medtronic Inc has confirmed that it had received a warning letter from U.S. health regulators calling for corrective actions based on an inspection of its Mounds View, Minnesota, facility, the headquarters of its cardiac rhythm management (CRM) business, the company’s largest unit. The letter from the Food and Drug Administration comes in the wake of problems Medtronic has had with its leads that are used with implantable cardioverter defibrillators, known as ICDs.

The FDA announced that roughly 5,400 HeartStart FR2+ automated external defibrillators made by Philips have been recalled because they may carry a defective memory chip that can render the life-saving devices inoperable. Although there have been reports of the memory chips in some of the defibrillators failing during routine self tests, none of them have failed during emergencies and caused patient injuries or deaths.

Zoll Medical Corp received the FDA marketing approval for a new model of its LifeVest wearable defibrillator. The LifeVest is worn by patients who are at a risk of sudden cardiac arrest. Zoll said more than 2,000 patients are currently using the product. The company aims to increase its inventory to support further growth.

The U.S. Food and Drug Administration has granted clearance to Physio-Control, Inc. for the commercialization of LIFEPAK 20e defibrillator/monitor in the United States. The device is an enhancement of the LIFEPAK 20. The new features include a stronger (Lithium-ion) battery and an on-screen fuel gauge. The novel version, also, is designed to facilitate easy transportation. This will help the hospitals to meet the standards set by Joint Commission for Accreditation of Healthcare Organizations to ensure the availability of resuscitation services in all the areas.

The Polymer Technology Group (PTG) indicated that its customer, Sunshine Heart Inc., has passed the five-year milestone on durability-testing of its C-Pulse implantable heart assist device. C-Pulse is designed to be a non-blood-contacting heart assist therapy for treating patients with moderate to severe heart failure, a condition in which the heart progressively loses its ability to efficiently pump blood throughout the body. C-Pulse includes two polymers from PTG.

Boston Scientific has received regulatory and reimbursement approvals from Japan for its Acuity Steerable heart failure lead. The company intends to launch the product in Japan immediately. After being implanted, the lead enables physicians to change the stimulation site in the heart without any invasion, the company said.

Boston Scientific Corp. has announced the commencement of the use of its Cognis cardiac resynchronization therapy defibrillator (CRT-D) and Teligen implantable cardioverter defibrillator (TM-ICD) by European doctors. Both these cardiac rhythm management devices received the CE Mark approval in January and are awaiting approval in the US. These are among the smallest and thinnest high-energy devices in the world and offer improved battery life and self-rectifying software.