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Thermedical Lands $5.5 in New Funding
Thermedical (Somerville, MA) secured $5.5 million in a Series A2 funding round. In total, the medical device startup has pulled in $7 million in funding. Thermedical manufactures thermal therapy equipment for use in laparoscopic, percutaneous surgery and other operations.
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Johnson & Johnson Will Exit Metal Hip Implant Market by 2014
Johnson & Johnson (New Brunswick, NJ) will exit the ceramic-on-metal and metal-on-metal hip implant markets by 2014. While the 10,000 lawsuits the company faces from concerns with its ASR hip implants might be considered as a factor in the company’s exit, Johnson & Johnson states that it is exiting the market due to upcoming FDA regulations that will make the approval and clearance process for new metal hip implants difficult.
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FDA Approves Thoratec's HeartMate II Pocket Controller
Thoratec (Pleasanton, CA) received FDA approval for its HeartMate II Pocket Controller. The HeartMate II is the user-operable interface of the HeartMate II Left Ventricular Assist Device (LVAD).
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Vascular Solutions Sues Boston Sci over Alleged Patent Infringement
Vascular Solutions (Minneapolis, MN) sued Boston Scientific over alleged patent infringement. The company believes that Boston Scientific’s Guidezilla extension catheter infringes on its patents.
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St. Jude Medical Receives CE Mark for Ilumien Optis PCI System
St. Jude Medical (ST. Paul, MN) received approval from the European Union for its Ilumien Optis PCI optimization system. The new system is designed to model the blood vessels of patients suffering from coronary artery disease. The system can also assist physicians during the placement of stents.
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Hospira Warned by FDA for Infusion Pump Manufacturing Issues
Hospira (Lake Forest, IL) received a warning letter from FDA regulators due to manufacturing concerns with the company’s infusion pump. In this warning letter from May 9th, FDA regulators detail issues with adverse event reporting, document controls, maintenance of records, corrective action and other failures in design.
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Telcare Receives CE Mark for Wireless Blood Glucose Meter
Telcare (Bethesda, MD) received CE Mark approval from the European Union for its wireless blood glucose meter, dubbed mHealth. This CE Mark represents the first entry of a wireless blood glucose meter into the European market.
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China Streamlines Regulatory Process for Domestic Innovations
Regulators at the China Food & Drug Administration have announced changes to the medical device regulatory approval and classification process. The changes are designed to lessen the regulatory issues associated with bringing an innovative medical device to market.
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Tryton Receives CE Mark for Side Branch Short Stent
Tryton Medical (Durham, NC) received CE Mark approval from the European Union for its Tryton Side Branch Short stent. The new stent is designed to increase the number of treatment options in large vessel bifurcations associated with a short main branch landing zone. The new stent is designed to be three millimeters shorter in a patient’s main branch zone when compared to a standard-sized Tryton Side Branch Stent.
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X-spine's Zygafix Facet Fusion System Receives FDA Clearance
X-spine (Miamisburg, OH) received FDA clearance for its Zygafix facet fusion system. The Zygafix system is designed to stabilize and fuse a patient’s facet joint. The surgical operation is used as a second order of treatment when pharmacological and non-surgical approaches have been ineffective.
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