FDA Approval Archives - Page 4 of 5

Patient Opinions on Devices Important to FDA

“New draft guidance from FDA gives industry more clarity on what patient perspective information can be considered for agency review, how best to collect this data, and how to incorporate the information into labeling” according to an article via...

Ever-Changing FDA Rules to Affect Class II Devices in September ’16

In a new article from MDDIonline.com, “FDA rules require medical device labelers to submit data to the Global Unique Device Identification Database (GUDID) for the highest-risk medical devices and will soon expand to moderate risk (Class II) devices in September...

FDA Grants Premarket Approval for New Heart Pump

The FDA has approved the first hemodynamic support device from AbioMed. The Impella 2.5 System has gained “premarket approval for use during high risk PCI procedures” according to an article via Forbes.com. The blood pump will be a temporary device for...

FDA Approves New Atrial Fibrillation Device

The FDA has approved Boston Scientifics new device for stroke patients with irregular heart rhythm known as atrial fibrillation, and will be made available to U.S. centers involved in Boston Scientific’s clinical studies and additional specialized centers,...

How to Win with the FDA

Getting regulatory approval from the FDA can prove to be a lengthy and frustrating process, with many procedures and processes that must be followed. Take a look at this article about “a heated public debate that took place during a recent FDA advisory...

« Older Entries

Next Entries »

VantagePoint Performance trains Salespeople to be more fluent and comfortable across different situations needing different sales approaches, and we train Sales Managers to be better coaches and team leaders, with more focus and less stress.

We’re different from the average sales training company because:

We don’t believe that one approach, one system, or one methodology is absolutely superior. All have something to offer, and the “best approach” or “best system” depends on the sales situation. This is what our applied, academic research tells us.
Our use of data science, specifically Machine Learning, helps us learn about our clients more meaningfully. We provide insights from each client’s data to help them understand what drives the success of their top-performing Salespeople and Sales Managers.
We are constantly feeding what we learn back into our training products, and we invest a bigger slice of our total energy into this innovation than the average sales training company. Our clients can access always-refreshed intellectual property and content through our training subscriptions.

Visit Sponsor Website