News

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...

NEWS FLASH--Orpheus Medical gains 510(k) clearance for VOD System for clinical video and imaging documentation platform with mobile app

The U.S. Food and Drug Administration (FDA) has 510(k) cleared Orpheus Medical's new clinical video and imaging documentation platform, which also includes a mobile app.

The company's system provides video capture, archive, and live-stream capabilities from any department and any video source, Orpheus Medical said. It integrates with a facility's electronic medical record as well as its PACS. Its mobile application allows clinicians to capture medical video, images, and audio files...

BioFire Receives FDA 510(k) Clearance for FilmArray® Torch with FilmArray® Respiratory Panel and Submits Special 510(k) Applications for Use with additional FilmArray® Panels

by Business Wire

MARCY L’ETOILE, France--()--Regulatory News: bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, today announced that BioFire Diagnostics, LLC, its molecular biology affiliate, has received Special 510(k)1 clearance from the U.S. Food and Drug Administration (FDA) to market the FilmArray® Torch for use with the FilmArray...

FUJIFILM Announces FDA 510(k) Clearance For Latest Innovation In PACS Technology: Synapse5

by PRNewswire

STAMFORD, Conn., Feb. 17, 2016 /PRNewswire/ -- FUJIFILM Medical Systems U.S.A., Inc. (a division of FUJIFILM Holdings Corporation OTC: FUJIY), a leading provider of diagnostic imaging products and medical informatics solutions, announced it has received FDA 510(k) clearance for the sale and distribution of its most recent innovation in PACS technology, Synapse 5. The latest offering of Fujifilm...

Fewer 510(k) Submissions from US Medical Device Firms in 2015

by Stewart Eisenhart at Emergo

In 2015, fewer US-based medical device companies submitted 510(k) applications to the Food and Drug Administration than at any point in the last five years.

Also last year, more 510(k) premarket notifications were submitted by foreign companies than at any point since at least 2011.

Overall 510(k) application numbers down

According to a new Emergo analysis of FDA 510(k) data, the number of 510(k) applications cleared by the FDA via...

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