September 18, 2015

FDA Approves ICD for MRI Scans

Device giant Medtronic has scored the FDA’s blessing to market an implantable cardioverter defibrillator system for use with MRI scans — the first approval of its kind. The Medtronic Evera MRI SureScan ICD System is approved for scans on any part of the body. Previously, patients with ICD systems were contraindicated from receiving such scans because of potential interactions between the MRI and device function.

It is estimated that about 36 percent of patients implanted with an ICD will need an MRI within four years. The approval was based on safety and efficacy data from the Evera MRI global clinical trial that enrolled 275 patients.

Physio-Control Nabs Irish AED Maker

Redmond, Wash.-based Physio-Control has agreed to buy Northern Ireland’s HeartSine Technologies for an undisclosed amount. HeartSine makes automated external defibrillators, and the combined company is expected to be one of the world’s largest providers of AED solutions. HeartSine’s offerings include the Samaritan PAD line of public access AEDs, and technologies such as CPR Advisor, which provides real-time CPR feedback.

Qualcomm Life Buys Capsule Technologie

A unit of wireless telecommunications giant Qualcomm has extended its reach into the field of medical device integration with its buyout of Capsule Technologie for an undisclosed amount. The acquisition gives Qualcomm Life, which focuses on remote home healthcare, access to Capsule’s hospital clientele.

Andover, Mass.-based Capsule provides medical device integration to more than 1,900 hospitals around the world, according to a Qualcomm statement. The Capsule acquisition will allow Qualcomm to supply delivery connectivity solutions across the continuum of care — from hospital to home.

Seegene, BD Partner on Diagnostic Assays

Seoul-based Seegene has signed a pact with BD Life Sciences to develop multiplex real-time polymerase chain reaction reagents for the BD MAX system. Seegene will develop and manufacture multiplex tests based on novel technologies, while BD will have worldwide commercialization rights to these tests. Seegene CEO Jong-Yoon Chun says the agreement represents a major step in his company’s expansion into the molecular diagnostics market.

Unilife Reduces Workforce

As part of a business realignment initiative, York, Pa.-based Unilife has laid off about 50 employees —about 17 percent of its workforce.

Announced during its fourth quarter and full year 2015 results, the company says the initiative will help it direct resources to support customer ramp schedules under existing supply agreements, as well as develop other relationships.