News

Hologic Announces FDA 510(k) Clearance and Commercial Availability of the Affirm™ Prone Biopsy System, the First 2D/3D™ Imaging-Guided Dedicated Prone Biopsy System

by PR Newswire

MARLBOROUGH, Mass., April 21, 2016 /PRNewswire/ -- Hologic, Inc. (Nasdaq: HOLX) today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance and commercial launch of the Affirm™ prone biopsy system, the first dedicated prone biopsy system to offer both 2D and 3D™ imaging-guided breast biopsies.

“At Hologic, we challenge...

FDA: TransEnterix Surgibot 510(k) submission does not meet criteria for “substantial equivalence”

by Fink Densford for Massdevice.com

TransEnterix (NYSE:TRXC) said today that the FDA responded to the 510(k) application for its robotic surgery SurgiBot system, saying that the platform does not meet the criteria for substantial equivalence based on the data and information in the application.

Research Triangle Park, N.C.-based TransEnterix claims SurgiBot as the 1st patient-side robotically enhanced laparoscopy platform, designed...

510(k) of the day--RECIPROCAL LABS Propeller System

RECIPROCAL LABS (doing business as Propeller Health) had a 510(k) cleared in March 2016 (k152882). The Propeller System clearance works with dry powder inhalers systems (DPIs).  The system includes a sensor that is an accessory device intended for single patient use, to assist physicians and patients in recording and monitoring the actuations of prescribed DPI usage for the Diskus devices.

Save your valuable time with kBLASTER's result management features of sorting, My...

Helius Medical raises $7 million for portable neuromodulation stimulator

by Brad Perriello for Massdevice.com

Helius Medical Technologies (OTC:HSDT) said today that it raised $7.2 million (C$9.2 million) in a Canadian short-form offering and a concurrent private placement in the U.S.

Newtown, Pa.-based Helius said each unit of the offering had a Class A share and a half-share warrant with an exercise price of roughly $1.17 (C$1.50). The company also said it got the go-ahead to list its share on the...

kBLASTER update April 2016: 510(k) search for predicates and successful 510(k) clearance strategy

The kBLASTER database has been updated today with FDA 510(k) clearances from March 2016 and FDA 510(k) splash pages for 510(k)s clearances in April 2016. If you have Saved Searches in your kBLASTER account that meet the parameters of today's imports into the kBLASTER database, you will see blue notification flags in your active kBLASTER account on those Saved Searches, as well as Alert email(s).  

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NEWS FLASH--TRISTAN TECHNOLOGIES Gains 510(k) Clearance for MagView BIOMAGNETOMETER SYSTEM as a Magnetoencephalograph

The U.S. Food and Drug Administration (FDA) announced this week it has 510(k) cleared the MagView BIOMAGNETOMETER SYSTEM neurology product by TRISTAN TECHNOLOGIES. MagView BIOMAGNETOMETER SYSTEM has a product classification code OLY which is described as a Magnetoencephalograph.

Save time with kBLASTER's unique result management features of sorting, My Favorites, Saved Search and Search History to quickly find your primary predicate, multiple predicates or ...

DICOM Grid Announces FDA 510(k) Clearance Of Next Generation Cloud PACS And Zero-Footprint Diagnostic Viewer

New York, NY – April 5, 2016 – DICOM Grid, makers of the leading cloud-based, medical image management suite, today announced FDA 510(k) clearance and new features for managing, viewing, and interpreting medical images with next generation cloud PACS and HTML 5, zero-footprint diagnostic viewer tools. To leverage these and other industry-leading...

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