medical device guru

Diagnostics & Healthcare News
Itamar Medical Reports Record Third Quarter Results
Itamar Medical, a company that develops, manufactures, and markets non-invasive diagnostic medical devices for sleep apnea with a focus on the cardiology market, today reported financial results for the third quarter of 2018. “We are pleased with the solid increase...
November 28, 2018
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
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
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
Diagnostics & Healthcare News
Psychedelic psilocybin therapy for depression granted Breakthrough Therapy status by FDA
In an extraordinary step forward for the psychedelic drug research community, the US Food and Drug Administration (FDA) has just given psilocybin therapy for treatment-resistant depression a Breakthrough Therapy designation. This classification suggests the treatment has demonstrated significant potential in...
October 25, 2018
Diagnostics & Healthcare News
First US Clinical Trial using Focused Ultrasound for Alzheimer’s Disease Underway
Researchers at the West Virginia University (WVU) Rockefeller Neuroscience Institute have treated the first patient in a new, groundbreaking clinical trial utilizing focused ultrasound to open the blood-brain barrier (BBB) in patients with early Alzheimer’s disease. Led by neurosurgeon Ali Rezai, MD,...
October 23, 2018
1 2 3 21