Wednesday, August 14, 2013

Clinica Analysis: Siemens scores top number of approvals in June

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A total of 65 approvals passed Clinica’s news desk in June, up from the 48 recorded in the same month last year, but down from the 73 seen in May 2013.

The June 2013 approvals included:
• 33 510(k) clearances from the US FDA;
• Four premarket approval (PMA) supplements from the FDA;
• One US emergency use authorization;
• 17 CE marks in the EU;
• Three Health Canada approvals;
• Two approvals from Japan’s Ministry of Health, Labour and Welfare (MHLW);
• One approval apiece in Korea and Argentina;
• One approval from the World Health Organization;
• One approval from Australia’s Therapeutic Goods Association.

The cardiovascular segment was again one of the most popular for approvals, in joint first place with in vitro diagnostics. Each sector saw 12 approvals. Diagnostic imaging was next, with seven, while orthopedics and surgery both posted five, and wound care four.

Figure 1. June approvals by type


The cardiovascular market has dominated the approvals chart for much of this year. It topped the list in May, with 19 approvals (, 4 June 2013), as well as January, February and March.

Figure 2. June approvals by product segment

Among the companies that reported product approvals, Siemens Healthcare topped the list with four FDA 510(k) clearances. These included its Immulite anti-CCP IgG assay to aid the diagnosis of rheumatoid arthritis; and its Virtual touch ultrasound elastography application, which is used to visualize tissue stiffness with several applications, for example in the diagnosis of liver disease.

Notable approvals in June 2013 included:

• An emergency use authorization for a test for the Middle East respiratory syndrome coronavirus, developed by the US Centers for Disease Control and Prevention;
 • A US PMA supplement for Lombard Medical Technologies’ Aorflex delivery device for its Aorfix stent, which is used to treat abdominal aortic aneurysms ( 21 June 2013). The approval allows Lombard to start a planned “aggressive” US push for Aorfix, which is scheduled to launch in Q3;
• CE marking of St Jude Medical’s next-generation quadripolar cardiac resynchronization therapy defibrillator (CRT-D), Quadra Assura MP, which the company claims is the industry’s first multipoint pacing system. The device has four electrodes to allow different pacing configurations, which St Jude says means it offers “maximum flexibility”;
• Japanese approval for St Jude’s MRI-safe Accent MRI pacemaker, the second onto this market after Medtronic’s Advisa DR MRI Surescan (, 28 June 2013);
• Japanese approval for Edwards Lifesciences’ next-generation Sapien XT transcathether aortic valve, the first such device to get the go-ahead in the country (, 25 June 2013).

See Clinica’s Approvals Table for more details of all the recorded approvals in June and previously.

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