News

FDA Nod in Hand, Health IT Software Maker Decisio Hits the Market

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by Angela Shaw for Xconomy

Houston’s Decisio Healthcare, a health IT company that makes software to create a critical care dashboard for ER and ICU staff, is now FDA approved. That distinction is notable, since seeking and obtaining regulatory approval is rare for medtech software companies. Most companies in the electronic health records industry are classified as medical device data systems and, therefore, don’t need the FDA sign-off.

“...

Spinal Simplicity Announces FDA 510(k) Clearance of the Minuteman Lateral Percutaneous Interlaminar Fusion Device

Submitted by kBLASTER Team on

by PRWeb

Overland Park, KS (PRWEB) January 12, 2015.  Spinal Simplicity, LLC, a spinal device company dedicated to the creation of innovative simple solutions to treat complex spinal disorders, announced today that FDA granted 510(k) marketing clearance for the Minuteman system.

The Minuteman, a pre-packaged sterile supplemental posterior fixation system, offers a minimally invasive alternative to traditional pedicle screws and other...

dBMEDx Announces FDA 510(k) Clearance of the BBS Revolution™ Bladder Scanner

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by PRNewswire

LITTLETON, Colo. and SEATTLE, Jan. 6, 2015 /PRNewswire/ -- dBMEDx, Inc., a privately-held, wireless medical device company, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its novel bladder scanner, the BBS Revolution™, a device...

FDA Issues Draft Guidance Titled "Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types"

Submitted by kBLASTER Team on

The FDA issued a draft guidance on January 16, 2015, titled "Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types". The primary goal of this draft guidance was to describe the use of the de novo classification process to classify accessories of a new type under Section 513(f)(2) of the FD&C...

Medtech investment hits 6-year high in Minnesota

Submitted by kBLASTER Team on

January 15, 2015 by Scott Wooldridge for MassDevice

Investment in medical device companies hit a 6-year high in Minnesota in 2014, according to data from LifeScience Alley's annual report on investing in the North Star State.

Investment in Minnesota's thriving medtech scene hit a 6-year high in 2014 and the state saw a significant jump in pharma/biotech investments, according to LifeScience Alley's annual report.

The group's "...

Cartiva Announces 510(k) Clearance for ProxiFuse Hammertoe Correction System

Submitted by kBLASTER Team on

Posted on January 7, 2015 by Josh Sandberg for OrthoSpine News

ALPHARETTA, GA. — Cartiva, Inc., (the “Company”) a developer of innovative solutions for the treatment of cartilage damage, osteoarthritis and other musculoskeletal conditions, announced today that it has received 510(k) clearance for its...

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