Approvals

OrbusNeich Gains FDA Clearance for Coronary Dilatation Catheters

The FDA has awarded marketing clearance to OrbusNeich’s Sapphire PTCA balloon dilatation catheters — the Sapphire II PRO and the Sapphire NC Plus.

The Sapphire II Pro has a tapered tip and an ultra-low profile, which allows insertion through tight lesions.

Sapphire NC Plus is indicated for dilatation of in-stent restenosis and post-delivery expansion of balloon expandable coronary stents.

3M’S Tegaderm CHG I.V. Gets FDA Clearance for Expanded Indication of Securement Dressing

The FDA has expanded the indication of 3M’s Tegaderm CHG Chlorhexidine Gluconate I.V. securement dressing to include catheter-related bloodstream infections.

The dressing is a translucent, gel pad applied to the area where an I.V. is placed to allow healthcare professionals to monitor the insertion site for early identification of complications and to minimize catheter movement and dislodgement.

Bayer Wins FDA Clearance of myBETAapp and Betaconnect Navigator

The FDA has approved Bayer’s supplemental Biologics License Application for myBETAapp and the Betaconnect navigator.

The autoinjector is used to administer Betaseron (interferon beta-1b) which uses Bluetooth to connect the autoinjector to the new myBETAapp on a mobile device or computer.

Betaseron is a prescription medicine used to reduce relapses in individuals with relapsing forms of multiple sclerosis.

SpaceOAR System Acquires Approval in Japan

Augmenix has received approval from the Japanese Ministry of Health, Labor and Welfare to market its SpaceOAR system in Japan. The device is an absorbable prostate-rectum spacer that reduces rectal injury during prostate radiotherapy.

The SpaceOAR system is CE marked, FDA cleared, approved in Australia and licensed in Canada.