Archives
Is Dexcom on Its Way to No More Fingersticks?
Dexcom is gearing up to support its request to FDA for a non-adjunctive, dosing claim for its continuous glucose monitors.
(April, 2016)
Abbott, St. Jude Combining to Create Medtech Giant
Abbott announced a $25 billion deal to acquire St. Jude Medical, a move that will transform it into a major medical device company with a much broader reach.
(April, 2016)
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.
(April, 2016)
Boston Scientific Earns FDA Approval for MR-Conditional Pacing System
FDA approves Boston Scientific's MR-conditional pacing system, including the first U.S. passive fixation pacing lead for MR scans.
(April, 2016)
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 ...
(April, 2016)
Lawmakers Want Speedy Medicare Reimbursement for Breakthrough Devices
Legislators propose a bill to reduce the time it takes to secure Medicare reimbursement for innovative medical technology.
(April, 2016)
Medtech Startup Showdown 2016: The Winner Is...
Which startup emerged victorious from the final round of our Medtech Startup Showdown?
(April, 2016)
FDA Proposes Ban on Controversial Electrical Stimulation Devices
A month after proposing a ban on powdered medical gloves, FDA announces it wants to ban electrical stimulation devices used to target aggressive or self-injurious behavior.
(April, 2016)
Patients, Clinicians Advocate for Cranial Electrotherapy Stimulators
Commenters write in to support cranial electrotherapy stimulators, Class III devices that FDA has recommended be reclassified into Class II for insomnia or anxiety use but be subject to a PMA for a depression indication.
(April, 2016)
Medtech Startup Showdown 2016: Finals—LineGard Med vs. Procyrion
 LineGard Medvs.Procyrion  Describe your device and how it will benefit healthcare.                           Clinical studies show that 7% of all I.V...
(April, 2016)
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!
(April, 2016)
Abbott Wins FDA Approval for First Companion Diagnostic in Leukemia
FDA has approved Abbott's companion diagnostic to detect a specific gene deletion in certain leukemia patients, part of its pairing with a drug intended to treat such populations.
(April, 2016)
A Blueprint for More U.S. Early Feasibility Studies
The Medical Device Innovation Consortium has released a practical guide to U.S. early feasibility studies in hopes of increasing participation by medtech companies.
(April, 2016)
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.
(April, 2016)
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.
(April, 2016)
Medtech Startup Showdown 2016: Round 3—NERv Technology vs Procyrion
 NERv Technologyvs.Procyrion  Describe your device and how it will benefit healthcare.                      NERv is developing an implantable biochip to monitor a patient's he...
(April, 2016)
New Bone Graft Aims to Make Fusions of the Neck Stronger
Cerapedics has developed the only FDA-approved bone graft approved for the cervical spine, which it believes can improve spinal fusion procedures.
(April, 2016)
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...
(April, 2016)
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.
(April, 2016)
New Material Can Stick It out in GI Tract
A team from MIT and Brigham and Women’s Hospital creates a pill device that sits in the gastrointestinal tract and enables extended drug release.
(April, 2016)
Abiomed Adds Cardiogenic Shock to Approved Indications
FDA approves use of the circulatory support company's Impella products for cardiogenic shock patients, a year after approving the high-risk PCI indication.
(April, 2016)
Changes Coming to FDA's Combination Product Oversight
FDA has started announcing shifts in the way combination products will be reviewed at the agency, as part of an effort to improve and clarify the process.
(April, 2016)
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...
(April, 2016)
More Patients On Digital Medicines Can Lower Blood Pressure
In a pilot study, patients using digital therapies with high blood pressure and type 2 diabetes were able to lower their blood pressure and bad cholesterol more than patients on regular care. 
(April, 2016)
Moving Closer to a National Device Evaluation System
A new planning board report details the role of a coordinating center to facilitate the much-anticipated national medical device evaluation system.
(April, 2016)