medical device guru

Diagnostics & Healthcare News
FDA Releases Plan to Modernize the 510(k) Pathway
The FDA today released plans for updating its 510(k) clearance pathway, including a push to move away from using predicate devices over 10 years old and the creation of a new alternative 510(k) pathway that will allow approval based on...
November 27, 2018
Diagnostics & Healthcare News
Boston Scientific to Acquire BTG for $4.2 Billion
Boston Scientific today announced it has reached an agreement on the terms of a recommended offer to acquire BTG plc., a company headquartered in the United Kingdom, which develops and commercializes products used in minimally-invasive procedures targeting cancer and vascular diseases,...
November 20, 2018
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
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