FDA Clearances

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Business Development & Investment Terms and Frameworks

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*Key People: Department of Energy (DOE)
*SI-BONE received clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System.
2010: AirStrip on iPhone Gets FDA OK for Remote Critical Care and Cardiology Monitoring Solutions (2010)
2010: FDA approves Zephyr’s remote patient monitor (2010)
2011: Boston Scientific gets FDA OK for three defibrillators (2011)
2011: Derma Sciences has announced FDA 510(k) approval of its MEDIHONEY Hydrogel Wound and Burn Dressing. (2011)
2011: FDA Approves BIOTRONIK's Latest Pacemaker Offerings (2011)
2011: FDA approves smartphone-based ultrasound system from Mobisante (2011)
2011: FDA clears first diagnostic radiology application for mobile devices (2011)
2011: FDA Clears Fresenius' 2008K@home Dialysis System (2011)
2011: FDA Clears New MediHoney Hydrogel for Treating Burns (2011)
2011: FDA drafts mobile medical app regulations (2011)
2011: GE Centricity Radiology app receives FDA nod (2011)
2011: Intuitive gets FDA OK for robot accessory (2011)
2011: iPro2 Continuous Glucose Monitoring Device Receives FDA Approval (2011)
2011: IsoRay gets FDA clearance for brain cancer therapy (2011)
2011: Mazor Robotics Received FDA Approval For Integration Of 3D Imaging Capabilities (2011)
2011: Mobile MIM 3.0 Gets FDA OK for Portable Radiology Diagnostics (2011)
2011: Seattle Genetics Wins FDA Approval of First Drug, a New Treatment for Lymphomas (2011)
2012: ACTUATED MEDICAL OBTAINS FDA CLEARANCE FOR TUBECLEAR, A SYSTEM THAT CLEARS PATIENT FEEDING AND DECOMPRESSION TUBES (2012)
2012: FDA clears NinePoint's OCT system (2012)
2012: InTouch Health Receives FDA 510(k) Clearance for Remote Presence Devices (2012)
2012: iRhythm Medical Magnetic Tape Recorder - FDA Clearnace (2012)
2012: Sotera Wireless Received FDA Clearance of Vital Signs Monitoring System (2012)
2012: Vivus Wins FDA Approval for Obesity Drug, After Long, Messy Day(2012)
2014: FDA approves Dexcom smartphone-enabled device for continuous glucose monitor
2014: LG receives FDA clearance, likely for a mobile health app
2016: HHS FY 2017 Budget Highlights_federaltelemedicine
AgaMatrix, Inc.
Ascom’s ClinicalConneX | Cardiomax achieves FDA Clearance (2011)
BMEYE Receives FDA Clearance to Launch ccNexfin, the First Totally Noninvasive Cardiovascular Monitor With BP, CO, and Masimo Rainbow SET(R) Technology in the United States
Canon gets FDA nod for DR detectors (2011)
Covalon Receives FDA Approval for Antimicrobial Silicone Adhesive Film (2012)
Diabetes: FDA releases artificial pancreas guidance (2011)
Endochoice
FDA _ 510(k) Clearance/Approval
FDA approved Momenta’s generic version of Lovenox, a blood-thinning drug from Sanofi (SNY) used in hospitals to prevent thrombosis.
FDA approves iglucose system - PositiveID Corporation™ (2011)
FDA Approves PROVENGE(R) for the Treatment of Men with Advanced Prostate Cancer (2010)
FDA Clears Curos Disinfecting Port Protector (2012)
FDA clears Monica’s wireless fetal heart rate monitor (2011)
FDA-cleared for treatment of early stage breast cancer, skin cancer and endometrial cancer, Xoft
Fluke Biomedical Receives FDA Clearance for ProSim Vital Signs Simulators (2011)
Given Imaging (GIVN:IT)
Glooko
Iconacy
In June Pfizer announced the first FDA-approved clinical drug trial involving all-electronic home-based reporting
Interrad Medical Receives FDA Clearance for the SecurAcath Universal System - A Revolutionary Subcutaneous Catheter Securement Device
K2M Inc.
Lightest and smallest oxygen concentrator on the market with FDA approval for continuous use by patients
Medicis Announces FDA Clearance of LIPOSONIX(R) System (2011)
Navigator DS Ultrasound Guided Drug Delivery System FDA OK'd (2011)
Ocular Therapeutix, Inc. (NASDAQ: OCUL),* Inc, formerly I-Therapeutix*
One of first companies to get 510(k) FDA clearance for mobile health DiabetesManager platform.
OptiMedica gets FDA approval for laser cataract system - Silicon Valley (2011)
Propeller Health, formerly Asthmapolis
Proteus Digital Health, formerly Proteus Biomedical
Sense4Baby
Sotera Wireless (Formerly, Triage Wireless)
Telcare
Tem Systems has received FDA 510(k) clearance on new tests for its hemostasis analyzer(2011)
Tomophase Corp
Topera Medical
U-Systems automated breast ultrasound moves closer to FDA approval (2012)
Vignet’s TeleHealth Manager received Class II 510(k) clearance from the FDA (2012)
Watermark also received 510(k) clearance for software that acted as a home health hub:
WebPAX received U.S. FDA 510(k) clearance in 2005 for viewing images and making geometric measurements on medical images over the Internet.

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