medical device guru

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

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