March 2016

Xtant Medical Announces FDA 510(k) Clearance of the Xspan™ Laminoplasty Fixation System

by Globe Newswire

BELGRADE, Mont., (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development of regenerative medicine products and medical devices, announced that its wholly owned subsidiary, X-spine Systems, received FDA clearance of the Xspan™ Laminoplasty Fixation System.

The Xspan™ System represents the latest generation of laminoplasty fixation. Spinal laminoplasty is a surgical procedure performed to remove pressure from the...

Tenex Health Secures FDA 510(k) Clearance for the TX2 MicroTip, Providing a Minimally Invasive Solution for Chronic Tendinosis

by PR Newswire

LAKE FOREST, Calif., March 29, 2016 -- Tenex Health Inc. has obtained FDA 510(k) clearance for its new TX2 MicroTip. The TX2 MicroTip will primarily be utilized to address tendinosis of the shoulder and hip, two areas that were more difficult to reach using the original TX1 MicroTip due to its length.

Tendinosis of the shoulder and hip affects approximately 5 million persons in the US alone every year. The company plans to make the TX2...

FDA 510(k) Clears CorPath Robotic System for Use in Peripheral Vascular Intervention

WALTHAM, MA - March 29, 2016 – Corindus Vascular Robotics, Inc. [NYSE MKT: CVRS], a leading developer of precision vascular robotics, announced today that the U.S. Food and Drug Administration has 510(k) cleared the CorPath® System for use in peripheral vascular interventions. This is the third clearance for the CorPath System including the initial clearance for percutaneous coronary intervention...

NEWS FLASH--QBTECH AB gains 510(k) clearance for QbCheck described as an Attention Task Performance Recorder

The U.S. Food and Drug Administration (FDA) announced today it has 510(k) cleared the QbCheck neurology product by QbTech AB.  QbCheck has a product classification code LQD which is described as an Attention Task Performance Recorder.

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 reference devices to build a successful 510(k) clearance strategy. Save money by enabling...

FDA 510(k) Clearance Granted to PneumaCare's Ground-breaking Thora-3DI™ Product for Non-contact Respiratory Measurement

by PR Newswire

PneumaCare Ltd (Cambridge, UK) announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Thora-3DI™ imaging device.

Thora-3DI™ is a non-invasive, non-contact device that uses a patented technology known as structured light Plethysmography (SLP) to measure breathing through detection of movement of the chest and abdomen. The technology can be used to accurately measure respiratory status in patients with a wide range of respiratory conditions, including asthma, chronic obstructive pulmonary disease (COPD),...

kBLASTER update March 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 February 2016 and FDA 510(k) splash pages for 510(k)s clearances in March 2016. If you have Saved Searches in your kBLASTER account that meet the parameters of today...

Spirox, Inc. Announces Closing of $45MM Series C Financing

by BusinessWire

MENLO PARK, Calif.--()--Spirox Inc., a privately held medical device company, announced today the closing of a $45 million Series C round of financing led by KKR, a leading global investment firm. In leading the round, KKR joins a strong syndicate of existing investors in the company. Also participating in the financing is new investor HealthQuest Capital along...

Intuitive Surgical wins FDA 510(k) clearance for new EndoWrist stapler

by Brad Perriello for MassDevice

Intuitive Surgical (NSDQ:ISRG) said today that the FDA cleared a new EndoWrist stapler for its next-generation da Vinci Xi root-assisted surgery device.

The 510(k) clearance for the EndoWrist 30 device covers straight and curved-tip staplers and 30mm reloads, the Sunnyvale, Calif.-based company said.

“Combined with the da Vinci Xi surgical system’s...

NEWS FLASH--SENSIMED AG gains de novo clearance for SENSIMED TRIGGERFISH ophthalmic product

by Fink Densford for MassDevice

The U.S. Food and Drug Administration (FDA) announced it has de novo cleared the SENSIMED TRIGGERFISH ophthalmic product with new product classification code PLZ. The FDA last week said it cleared SensiMed’s Triggerfish sensor-embedded contact lens designed to detect fluctuations in the eye’s volume to identify the optimal time to...

Dictum Health’s IDM100 Tablet for remote monitoring of patients and telehealth FDA 510(k) Cleared

reported in MedGadget

Dictum Health, a firm out of Oakland, California, landed FDA clearance for its IDM100 medical tablet. The device is part of the firm’s telehealth system that provides clinicians remote monitoring of patients, including live video and streaming of vitals. It can be used both at the clinic or taken by the patient home and is designed to capture 3 and 12 lead ECG and works as a digital stethoscope. Two cameras are used to either do...