A blog about what is new (and old) in the world of active implantable medical devices 

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Home Archive for category "AIMD Business"
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Submitting AIMD System Applications to China’s State FDA

I just came back from Beijing where we are in the process of registering our AIMD systems.  The process if very different than submitting an application to a EU Notified Body or to FDA.  This is because China’s State FDA (S-FDA) doesn’t accept testing performed abroad.  S-FDA only accepts testing performed at one of the Chinese

 
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St. Jude Medical Announces Q4 2013 Results: CRM Up 4%, Neuromodulation Up 2%

St Jude Medical announced that its Cardiac Rhythm Management sales increased 5 percent on a constant-currency basis over the fourth quarter of 2012.  Neuromodulation sales for the same period increased by 2%.  According to the press release: Cardiac Rhythm Management Total CRM sales, which include implantable cardioverter defibrillator (ICD) and pacemaker products, were $705 million for

 
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Boston Scientific Announces Q4 2013 Results: CRM Up 3%

Boston Scientific announced that it has continued to improve performance in the company’s Cardiac Rhythm Management business, achieving revenue growth of 3 percent versus the prior year period on a constant currency basis from $457M to $468M.

 
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Cyberonics Reports Record Sales for its Fiscal Q2 2014

Cyberonics reported $70.1 million in sales for the quarter (fiscal Q2 2014), up around 12% from than $62.9 million booked in the fiscal 2013 second quarter. Net income grew, but at a more moderate pace. It surpassed $13.8 million, versus $13.5 million in net income booked during the same period a year ago.  Operating result highlights for

 
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Medtronic Reports CRM AIMD Sales Trend Showing Stabilization + Strong Earnings from Neuromodulation AIMDs

Medtronic released today its earning reports for the second quarter of fiscal year 2014, which ended October 25, 2013. Medtronic states in the press release: “Second quarter revenue from Implantable Cardioverter Defibrillators (ICDs) was $713 million, an increase of 4 percent on a constant currency basis in a market that continues to show a trend

 
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Quallion Being Acquired by EnerSys. Medical Battery Technology Said to be Key Strategic Priority.

EnerSys, a global leader in stored energy solutions for industrial applications, announced that it has entered into an agreement to acquire Quallion LLC, a manufacturer of lithium ion cells and batteries for high integrity applications for $30 million.   Quallion’s innovative cells – especially rechargeable Zero-Volt ™ lithium-ion batteries – are used in quite a few implantable

 
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Changes in EU Rules for Medical Device Approvals

There has been some discussion in Europe over the last year to tighten the rules for medical device approvals. This discussion arose due to some scandals with breast implants in recent years.  One of the things being considered was a regulatory approval process similar to the PMA process in the US. The European Parliament has

 
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Boston Scientific Posts 1% Increase in Q3 2013 CRM Sales

From today’s press release: “Improved performance in the company’s Cardiac Rhythm Management and Interventional Cardiology businesses, with CRM achieving growth of 1 percent on a constant currency basis.”  Sales increased from $462M in Q3 2012 to $464M in Q3 2013, which represents a 1% change in constant-currency basis.

 
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St. Jude Q3 2013 AIMD Results: CRM Down 1%, Neuromodulation 3% Up

From today’s press release: Cardiac Rhythm Management (CRM) Total CRM sales, which include implantable cardioverter defibrillator (ICD) and pacemaker products, were $682 million for the third quarter of 2013, a 1 percent decrease compared to the third quarter of 2012. After adjusting for the impact of foreign currency, total CRM sales were flat. Of that

 
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St. Jude Acquires Nanostim, Announces CE Mark of World’s First Leadless Pacemaker

St. Jude Medical today announced the completion of its acquisition of Nanostim, Inc., a privately-owned developer of miniaturized, leadless pacemakers. The acquisition adds the world’s first and only leadless pacemaker to the St. Jude Medical product portfolio. According to the press release: Unlike conventional pacemakers that require a more invasive surgery, the Nanostim™ leadless pacemaker

 
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Cyberonics Reports 12.4% Increase in VNS Sales for Fiscal Q1 2014

Net product sales increased 12.4% to $67.4 million in the first fiscal quarter ended July 26 for Cyberonics, Inc. of Houston, TX. Including license revenue, sales were up 14.2% overall, with Europe in particular contributing a strong performance. Diluted earnings per share were adjusted by $0.17 cents due to a litigation settlement. According to the

 
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Boston Scientific’s Q2 2013 AIMD Results: CRM Down 3%, Neuromodulation Up 21%

Today Boston Scientific announced its Q2 2013 results.  CRM sales were 3% down from $488M for Q2 2012 to $475M this year (2% on constant-currency basis). Neuromodulation went up by a whopping 21% from last year’s Q2 $91M to $111 in Q2 2013.  The press release indicated that Boston Scientific achieved global year-over-year revenue growth

 
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St. Jude Q2 2013 AIMD Results: CRM Down 4%, Neuromodulation 2% Up

From today’s press release: “Cardiac Rhythm Management (CRM) Total CRM sales, which include implantable cardioverter defibrillator (ICD) and pacemaker products, were $718 million for the second quarter of 2013, a 4 percent decrease compared to the second quarter of 2012. After adjusting for the impact of foreign currency, total CRM sales decreased 2 percent. Of

 
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NeuroPace Raises $18M of Planned $50M

NeuroPace is a privately-held company in Mountain View, CA. Their RNS® implantable stimulator, along with depth leads and cortical strip leads are designed for the treatment of medically refractory partial epilepsy. Unlike Cyberonics’ VNS IPGs, the RNS neurostimulator is designed to detect abnormal electrical activity in the brain and respond by delivering electrical stimulation to

 
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Boston Scientific’s Q1 3013 AIMD Results: CRM Down 4%, Neuromodulation Up 6%

Boston Scientific Corporation announced today that it generated sales of $1.761 billion and adjusted earnings per share of $0.16 for the first quarter ended March 31, 2013.  These were the results for their AIMD businesses : Cardiac Rhythm Management declined 5% (4% using constant-currency basis) to $478M in Q1 2013 compared to $501M in Q1 2012. Neuromodulation was up

 
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