Company	Product name	Countries	Approval type	Product description	Indication	Date reported
Terumo BCT	Spectra Optia Apheresis System	Europe	CE mark	Plasmapheresis device	Centrifugal therapeutic apheresis and cell collections platform and is the first and only device on the European market today approved to treat uillain-Barré Syndrome and myasthenia gravis using therapeutic plasma exchange.	4/6/17
iVascular S.L.U	iVolution	Europe	CE mark	Cardiovascular - "Last generation" nitinol peripheral stent	200 mm length of self-expandable stent. Combines high flexibility and conformability with high radial strength. For TASC II C and D femoro-popliteal lesions.	4/3/17
Reva Medical Inc.	Fantom Bioresorbable Scaffold	Europe	CE mark	Cardiovascular - Bioabsorbable coronary stent	CE mark based on the FANTOM II clinical trial, which showed a 2.1% six-month MACE rate in 240 patients with lesions in native coronary arteries with average reference vessel diameter 2.5mm to 3.5mm.	4/3/17
Shanghai MicroPort Medical	Firehawk Rapamycin Target Eluting Coronary Stent System	Colombia	INVIMA approval	Cardiovascular - Drug-eluting stent	Coronary DES with in-groove abluminal coating design and target-eluting technique to allow same clinical efficacy with significantly low drug loading, benefiting vascular early healing, according to the company.	4/10/17
Contego Medical	Vanguard IEPa	Europe	CE mark	Cardiovascular - Peripheral angioplasty balloon system	Peripheral balloon with integrated embolic protection for lower lower-limb angioplasty	4/27/17
Occlutech	PmVSD Occluder	Europe	CE mark	Cardiovascular - Septal defect closure	Nitinol mesh closure device indicated for the minimally invasive closure of perimembranous ventricular septal defects.	4/4/17
Cardinal/Cordis	Railway	Europe	CE mark	Cardiovascular - Sheathless access system for radial arterial catheterization procedures	Allow direct access to the radial artery with a guiding catheter, but without a sheath, which reduces the size of the arterial puncture site up to 2 F, compared to a conventional sheath system.	4/18/17
New Valve Technology	Allegra	Europe	CE mark	Cardiovascular - Transcatheter aortic valve	Three difference valve sizes for annulus size ranging from 19 mm to 28 mm in diameter with the Allegra delivery system, and the Allegra loading system.	4/3/17
Milestone Scientific	CompuFlo	Australia/New Zealand	Approval	Drug delivery - Epidural system	Features Dynamic Pressure Sensing to provide feedback that allows anesthesiologists to correctly identify the epidural space.	4/4/17
Milestone Scientific	CompuFlo	Australia/New Zealand	Approval	Drug delivery - Intraarticular computer controlled injection system for osteoarthritis	Improves accuracy of drug-delivery to reduce patient discomfort and prevent needle deflection.	4/4/17
Singulex Inc.	Sgx Clarity System for ACS	Europe	CE mark	IVD - Cardiac troponin (cTnl) assay for Sgx Clarity system	Sgx Clarity test for acute coronary syndrome	4/3/17
Singulex Inc.	Sgx Clarity System	Europe	CE mark	IVD - Fully-automated, in vitro diagnostics platform, powered by Single Molecule Counting.	IVD platform with Single Molecule Counting technology measures biomarkers at the lowest levels.	4/3/17
Roche Holding AG	cobas Liat PCR System for diagnostic platform	Europe	CE mark	IVD - PCR system with four assays	Real-time PCR nucleic acid test platform	4/3/17
Roche Holding AG	cobas C.diff test for clostridium	Europe	CE mark	IVD for clostridium difficile	Automated, in vitro diagnostic, real-time PCR test for cobas Liat PCR system	4/3/17
Great Basin Scientific	Stool Bacterial Pathogen Panel for Infectious Disease	Europe	CE mark	IVD for Salmonella species, Shigella species, Shiga Toxin-producing E. coli (stx1, stx 2, O157 serotype-specific genes), and Campylobacter species (C. jejuni and C. coli)	Great Basin says the test better supports customer needs with an easy-to-use workflow of less than two minutes hands-on steps, and a turnaround time of under two hours, compared to conventional tests that are labor intensive, requiring multiple individual tests with poor sensitivity and long turnaround times.	4/12/17
Soterix	HD-tDCS	Brazil	ANVISA approval	Neurostimulator - High-Definition Transcranial Direct Current Stimulation	For neurology indications including chronic pain and Down's syndrome	4/13/17
Soterix	Depression LTE	Brazil	ANVISA approval	Neurostimulator - Limited Total Energy Transcraial Direct Control stimulator	For bipolar disorder and major depressive disorder	4/13/17
Soterix	PainX tDCS	Brazil	ANVISA approval	Neurostimulator - Non-invasive, non-systemic delivery of low-intensity direct current to a region of the cerebral cortex to either control perception of pain or modulate reaction to painful experiences	Approved for Migraine, other headaches, fibromyalgia	4/13/17
Soterix	1x1 tDCS	Brazil	ANVISA approval	Neurostimulator - Transcranial Direct Current Stimulation	For neuropathic pain, motor recovery, mild cognitive impairment, major depressive disorder, and chronic pain.	4/13/17
Silver Bullet Therapeutics	OrthoFuzion Antimicrobial Bone Screw System	Europe	CE mark	Orthopedics - Bone screw	Features advanced silver ion technology that allows for rapid ionization of the silver and creation of an antimicrobial zone around the screw to prevent microbial colonization of the implanted devices.	4/21/17
Amedica	Valeo VBR for disc and spine repair	Australia/New Zealand	Approval	Orthopedics - interbody fusion device for spinal fusion	Interbody fusion device made of Amedica's proprietary medical grade silicon nitride ceramic, which offers nanostructured surface, osteoconductivity, osteoinductivity, anti-microbial properties, and ease of radiographic imaging.	4/24/17
Amedica	Valeo Spacer System for Disc and Spine Repair	Australia/New Zealand	Approval	Orthopedics - interbody fusion device for spinal fusion	Interbody fusion device made of Amedica's proprietary medical grade silicon nitride ceramic, which offers nanostructured surface, osteoconductivity, osteoinductivity, anti-microbial properties, and ease of radiographic imaging.	4/24/17
Amedica	Valeo OL Interbody Fusion Device for Disc and Spine Repair	Australia/New Zealand	Approval	Orthopedics - interbody fusion device for spinal fusion devices	Interbody fusion device made of Amedica's proprietary medical grade silicon nitride ceramic, which offers nanostructured surface, osteoconductivity, osteoinductivity, anti-microbial properties, and ease of radiographic imaging.	4/24/17
Amedica	Valeo II Interbody Fusion Device for Disc and Spine Repair	Australia/New Zealand	Approval	Orthopedics - interbody fusion device for spinal fusion devices	Interbody fusion device made of Amedica's proprietary medical grade silicon nitride ceramic, which offers nanostructured surface, osteoconductivity, osteoinductivity, anti-microbial properties, and ease of radiographic imaging.	4/24/17
NICO Corporation	BrainPath	Europe	CE mark	Surgery - Brain access system	Helps neurosurgeons access the subcortical space with an atrumatic tip that gently displaces brain tissue to create a corridor to the tumor or hemorrhage site.	4/4/17
Creo Medical Ltd.	Speedboat RS2	Europe	CE mark	Surgery - Electrosurgery platform	For the application of microwave energy to coagulate bleeds in the colon.	4/3/17
Intuitive Surgical	da Vinci X	Europe	CE mark	Surgery - Surgery robot	Lower-cost version of da Vinci surgical robot	4/26/17
Z-Medica	QuikClot	Brazil	ANVISA approval	Wound healing - Line of hemostatic products	For severe wounds. Will be marketed to Brazilian military, hospitals and emergency medical services.	4/11/17

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