medical device guru

Diagnostics & Healthcare News
Boston Scientific to Restructure, Expects $200M in Cut Costs
Boston Scientific said yesterday that it’s planning a three-year restructuring program that’s slated to cost at least $200 million. The Marlborough, Mass.-based medical device maker said it expects to maintain roughly the same number of workers, although there will be...
November 16, 2018
Cardiovascular / Cardiology
Itamar Medical Gets Favorable CMS Reimbursement Decision for WatchPAT Technology
Itamar Medical Ltd. today announced the release of the 2019 Fee Schedule from the U.S. Centers for Medicare & Medicaid Services (CMS) that should support broad use of its WatchPAT technology. WatchPAT is the only product on the market today...
November 9, 2018
Diagnostics & Healthcare News
FDA Approves Implantable Glucose Monitor Insertion/Removal by Non-Physicians
Senseonics Holdings, Inc., a medical technology company focused on the development and commercialization of a long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, today has announced that the Eversense® Continuous Glucose Monitoring (CGM) System has received FDA approval...
November 7, 2018
Imaging Visualization & Navigation
FDA Clearance for Artificial Intelligence Upgrade to Ninepoint’s Imaging System
NinePoint Medical, Inc., a transformative medical device company pioneering the use of a real-time imaging platform for gastrointestinal applications, announced today that it has received U.S. Food and Drug Administration (FDA) clearance to market its Intelligent Real-time Image Segmentation™ (IRIS)...
November 6, 2018
Orthopedics and Spine
RTI Surgical to Acquire Paradigm Spine for $300M
RTI Surgical, Inc., a global surgical implant company, and Paradigm Spine, LLC, a leader in motion preservation and non-fusion spinal implant technology, today announced that they have entered into a definitive agreement whereby RTI will acquire all outstanding equity interest...
November 2, 2018
Surgery and Surgical Robotics
Is the Appendix the Key to Parkinson’s Disease? 
Parkinson’s disease, a degenerative neurological disorder that impairs brain cells and causes movement problems, could have its origins in the appendix, a new study suggests. The vestigial organ, the researchers say, could be the source of proteins that can find...
November 2, 2018
Diagnostics & Healthcare News
In-Home Fertility Tracking System Wins CE Mark
Concepta plc, the innovative UK healthcare company and developer of the proprietary self-test platform (“myLotus”) and suite of emerging test products targeting the mobile health market is pleased to announce it has received CE-Mark certification for its myLotus branded products for...
November 1, 2018
Diagnostics & Healthcare News
Medical Rep Rebuked by FDA for Misleading Statements during Doctor’s Lunch
The latest admonishment from the FDA’s promo police is an unusual one. In it, the agency scolds an Eisai sales rep accused of misleading healthcare professionals during a presentation on antiseizure drug Fycompa. What’s different about the FDA’s latest untitled...
October 30, 2018
Imaging Visualization & Navigation
Novarad Lands FDA Clearance for its HoloLens-augmented Preoperative System
The possibilities of Microsoft’s HoloLens system have become a hot topic in the medical world in recent years. But last week Novarad’s OpenSight Augmented Reality System received FDA clearance for pre-operative surgical planning using the tech company’s augmented reality headset. The newly FDA-cleared system...
October 30, 2018
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