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Ultralow power transistor could power device without batteries
Researchers from the University of Cambridge have developed a new form of transistor that drastically reduces the amount of power used by a device, according to a new study published in Science....
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FDA approves Jarvik Heart trial for pediatric cardiac assist device
Jarvik Heart said today that the FDA approved an investigational device exemption trial of its miniature left ventricular assist device in patients of less than 1 year of age to 10 years. The...
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FDA to docs: Don’t use Multidata’s radiation therapy devices
The FDA today released a warning over issues with devices manufactured by Multidata Systems International. The federal watchdog said it knows of “at least 2” Multidata medical devices that the company...
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Heater-cooler issue expands to snare Maquet
Getinge‘s (PINK:GETI B) medical subsidiary Maquet Medical Systems is the latest to announce issues with bacterial contamination associated with its surgical heater-cooler units, according to a field...
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Teleflex recalls tracheostomy sets on disconnection risk
Teleflex (NYSE:TFX) today issued a recall for select Willy Rusch TracheoFlex tracheostomy tube sets due to possible disconnection issues. The federal watchdog labeled the recall as Class 1, indicating...
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FDA clears pediatric spine implants from Medicrea
Medicrea (EPA:ALMED) said today it won FDA 510(k) clearances for is Pass XS posterior fixation and LigaPass XS band connector components designed for pediatric spinal deformities in small stature...
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US regulators propose labeling submission rules for higher-risk home use...
By Stewart Eisenhart, Emergo Group EMERGO SUMMARY OF KEY POINTS: The US FDA has proposed requiring electronic submission of labeling data for Class II and III home-use devices. Submitted data would be...
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Wright Medical closes $32m large joints sale to Corin Orthopaedics
Wright Medical (NSDQ:WMGI) said today that it closed the $32.3 million sale of its large joints business to Corin Orthopaedics Holdings last week, for net proceeds of about $20 million. The €29.7...
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Merit Medical reveals U.S. Justice Dept. subpoena
Merit Medical (NSDQ:MMSI) said last week that the U.S. Justice Dept. issued a subpoena seeking information on its marketing practices. The Oct. 19 subpoena seeks “documents and other information...
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Philips soars on Q3 profit surge
Third-quarter profits surged more than 18% for Royal Philips (NYSE:PHG), sending its share price to a 19-month high as the Dutch conglomerate continues its shift toward healthcare. Philips posted...
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ConforMIS lures ex-Integra Lifesciences prez Augusti for CEO spot | Personnel...
Augusti ConforMIS (NSDQ:CFMS) said today that it named Integra LifeSciences (NSDQ:IART) president Mark Augusti to succeed founder Dr. Phillip Lang as president & CEO effective Nov. 14. Augusti, who...
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Bacterial nanostructures developed to locally deliver proteins
panish researchers demonstrated that bacterial inclusion bodies, non-toxic nanostructures, hold promise for a sustained, local delivery of protein drugs by mimicking components of a mammal’s endocrine...
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Cytori touts regenerative cell therapy data
Cytori Therapeutics (NSDQ:CYTX) touted the publication of preclinical safety and efficacy data for its cell therapy treatment for combined radiation and thermal injury. The San Diego-based company...
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Svelte Medical wins CE Mark for Direct coronary stent
Svelte Medical Systems said today that it received CE Mark approval in the European Union for its Direct sirolimus-eluting coronary stent. The stent uses a coating of sirolimus and a natural, amino...
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NovioSense closes 4th financing round for tear glucose sensor
NovioSense said today that it closed a 4th financing round to support the upcoming clinical validation phase of its smartphone-based tear glucose sensor device. The round included existing investors...
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Outside firm backs up short-seller’s claims against St. Jude Medical
Short-selling firm Muddy Waters said today that outside cybersecurity experts validated its claim that cardiac rhythm management devices made by St. Jude Medical (NYSE:STJ) are vulnerable to malicious...
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MDT launches MiniMed Connect app for Android
Medtronic (NYSE:MDT) said today that its MiniMed Connect app, which allows patients with diabetes to see a real-time glucose measurement on their smartphone, is available for Android devices. The app,...
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Legal win leaves Vascular Solutions CEO Root weary of the corner office
Root After being acquitted of federal felony charges for off-label marketing and a prosecution that spanned 5 years, Vascular Solutions (NSDQ:VASC) CEO Howard Root said he’s still recovering from the...
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FDA is working with hospitals to modernize data collection about medical devices
By: Jeffrey Shuren, M.D., J.D. America’s hospitals and their dedicated staff helps us fight disease and suffering by delivering life-saving and life-enhancing care every day in an astounding variety of...
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FDA seeks to improve hospital reporting of device injuries
(Reuters) – The U.S. Food and Drug Administration is seeking to improve hospital reporting of injuries and deaths associated with medical devices after inspections at 17 hospitals revealed widespread...
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