Oct. 15, 2014, 7:34 AM| Comment!
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Oct. 1, 2014, 10:05 AM
- In response to the ever-increasing risk of security breaches, the FDA issues final guidance for device makers entitled, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." The agency recommends that device manufacturers consider cybersecurity risks at part of the design and development of their products and submit documentation to the FDA about the risks identified and the controls in place to mitigate them. The agency also recommends that companies submit their plans for patches and upgrades to device operating systems and medical software.
- The agency will hold a public workshop on October 21, 2014 to discuss how all the constituency groups can work together to improve cybersecurity in medical devices and protect the public health.
- ETFs: IBB, BIB, IRY, IXJ, BIS, DRGS
- Some related tickers: (MDT -0.2%)(BSX -0.9%)(STJ -0.3%)(ABT -0.6%)(JNJ -1.4%)(OTCQX:RHHBY +0.1%)
Sep. 15, 2014, 11:51 AM
- The FDA and EC issue 510(k) and CE Mark clearances, respectively, to St. Jude Medical (STJ -1.1%) for its Optis Integrated System, which is directly installed into a hospital's cardiac catheterization laboratory. It fully integrates optical coherence tomography (OCT) and fractional flow reserve in percutaneous coronary intervention (PCI) workflow.
- It is the first PCI optimization system to offer OCT and angiography co-registration. It supports procedural decisions by providing high-resolution 3D OCT views of coronary anatomy while mapping the exact location of the current view via angiogram.
- It also integrates the company's PressureWire fractional flow reserve measurement technology which provides hemodynamic information during PCI.
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Jul. 16, 2014, 8:21 AM
- St. Jude Medical (NYSE:STJ) Q2 results: Total Revenues: $1,448M (+3.2%); ICD: $462M (+1.8%); Pacemakers: $271M (+2.7%); AF: $257M (+8.4%); Cardiovascular: $351M (+3.2%); Neuromodulation: $107M (-0.9%).
- COGS: $433M (+13.4%); R&D Expense: $178M (+2.9%); SG&A Expense: $523M (+7.0%); Net Income: $270M (+134.8%); EPS: $0.93 (+132.5%); Quick Assets: $1,580M (+29.5%).
- Gross Profit: $1,015M (-0.6%); COGS%: 29.9% (+9.8%); Gross Margin%: 70.1% (-3.7%); Operating Profit: $314M (-12.5%); Operating Earnings Yield: 21.7% (-15.3%); Net Earnings Yield: 18.6% (+127.5%).
- 2014 EPS guidance raised to $3.96 - 4.01 from $3.76 - 3.81 on revenues of $5.64B - 5.76B.
Jul. 16, 2014, 7:31 AM
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Jul. 14, 2014, 9:58 AM
- St. Jude Medical (STJ -0.8%) enters into a definitive agreement to acquire privately-held NeuroTherm, a maker of interventional pain management therapies, for ~$200M in cash. The company expects to conclude the transaction in late Q3. NeuroTherm will add $10M - 15M to STJ's top-line sales in 2014.
- NeuroTherm's technology utilizes radiofrequency ablation (RFA) to treat spinal pain.
May. 28, 2014, 12:58 PM| Comment!
May. 14, 2014, 7:54 AM
- Surgical teams at Los Angeles' Cedar Sinai Hospital and New York's Lenox Hill Hospital successfully implant St. Jude Medical's (STJ) Portico Transcatheter Aortic Heart Valve signifying the start of the PORTICO clinical trial. The product is fully repositionable until fully deployed. Trial patients will be those who have a high or extreme surgical risk for open-heart surgery.
- The product is CE Mark-designated in Europe but investigational in the U.S.
May. 7, 2014, 12:18 PM
- The FDA approves the Entovis pacemaker system with ProMRI technology made by Berlin, Germany's Biotronik. The device allows patients to undergo MRI scans with a limited exclusion zone. Entovis patients need only to alert radiology staff and they will verify that they are eligible to undergo the imaging. The company believes that this is a significant advantage over MRI-conditional pacers. The FDA's approval covers both single and dual chamber pacemakers when implanted with Setrox leads.
- Recent research finds that there is a 50 - 75% probability that patients implanted with a pacemaker or defibrillator will need an MRI at some point in their lives.
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St Jude Medical Inc develops, manufactures and distributes cardiovascular medical devices for global cardiac rhythm management, cardiovascular, atrial fibrillation therapy areas and neurostimulation medical devices for the management of chronic pain.
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