FDA Rejects First Digital Medicine
Instead of an approval, FDA has sent Proteus Digital Health and Otsuka Pharmaceutical a complete response letter asking for more information about their digital drug-device combination product.
New Device Aims to Ease Burden of Treating Ureteral Blockages
Severe ureteral obstructions require two invasive procedures, but a startup aims to pack a one-two punch to tackle the problem. Arundhati ParmarUreteral obstruction can be painful because it blocks the flow of urine and can ultimately affect the kidneys.Sometimes the blockage is so severe that ...
Medtech Startup Showdown 2016: Finals
These two startups have made it to the final round of our Medtech Startup Showdown. Vote for your favorite and tell us why that company deserves to win!
New Kit Gives OEMs a Chance to Tinker
Tekscan's FlexiForce OEM Development Kit gives engineers a chance to explore new designs without spending a significant amount of time or money on the process.
Dexcom Issues CGM Receiver Recall
Dexcom announces a recall of its G4 Platinum and G5 Mobile continuous glucose monitors because the devices' audible alarm may not sound in hyperglycemia or hypoglycemia situations.
Medtech Startup Showdown 2016: Round 3—LineGard Med vs VuVatech
LineGard Medvs.VuVatech Describe your device and how it will benefit healthcare.Clinical studies show that 7% of all I.V. lines are dislodged. In the United States alone, there are over 200 million I.V. lines placed annually. I.V. Dislodgment is estimated to cost the U.S. healthcare...
Medtech Startup Showdown 2016: Round 3
These medical device startups have made it to the Final Four of our Medtech Startup Showdown. Your vote will determine which two companies make it to the finals.
Medtronic Wins Pacemaker Approval Race Against St. Jude
FDA approves the first transcatheter pacemaker made by Medtronic that has no leads in the heart.Arundhati ParmarIn what will likely be a surprise for analysts who were expecting the green light later in the year, FDA announced Wednesday that that it has approved the first leadless pacemaker in the U...