Quantel Medical, a France-based provider of technologies for the treatment of ocular diseases, has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its Vitra Multispot laser system. The device, which features ...
Tags: FDA, Multispot laser system, Medical
The US Food and Drug Administration (FDA) has granted 510(k) clearance to RTI Biologics' porcine dermis implant for use in soft tissue repair procedures such as hernia repair. The implant is comprised of non-crosslinked porcine dermis and ...
Tags: FDA, biologics portfolio, RTI Biologics
Invendo Medical, a developer of disposable endoscopy products, has installed its single-use colonoscope at two GI endoscopy centers including NYU Langone Medical Center and NewYork-Presbyterian Hospital/Columbia University Medical Center. ...
Tags: Invendo, colonoscope, Medical
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Royal Philips Electronics' full-field digital mammography (FFDM) system. Having the capability to enable future Single-Shot Spectral Imaging applications like ...
Tags: FDA, clinicians, FFDM
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Dallen Medical's Compressyn Staple, designed for use in rigid small bone fixation, specifically in foot, ankle, and hand applications. Using the company's patented ...
Planmed Oy has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its Planmed Verity Extremity Scanner for providing fast 3D imaging of subtle extremity fractures that have been missed when using 2D radiographs at ...
US-based Modern Plastics has announced that a spinal implant device using Evonik's VESTAKEEP PEEK (polyetheretherketone) has obtained 510(k) clearance from the US Food and Drug Administration (FDA). The implant device, which exhibits ...
Tags: Modern Plastics, Evonik, VESTAKEEP PEEK, FDA
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Stanmore Implants' Sculptor Robotic Guidance Arm (RGA) for unicompartmental knee replacement surgery, also known as partial knee resurfacing. Partial knee ...
Tags: FDA, surgical, orthopaedic market
US gastrointestinal endoscopy company EndoChoice has purchased German-based endoscope manufacturer RMS Endoskopie-Technik. Under the acquisition, Full Spectrum Endoscope, a portfolio product of Peer Medical which is now merged with ...
Tags: EndoChoice, RMS Endoskopie-Technik, purchase, endoscope
In keeping with its commitment to excellence and innovation, Masimo announced the debut of the iSpO2 pulse oximeter cable and sensor with Measure-Through Motion and Low Perfusion Masimo SET technology for use with iPhone, iPad or iPod touch ...
Tags: Masimo, iSpO2, iPhone, iPad, iPod touch
SinuSys has received regulatory approvals from Health Canada and Australian Therapeutic Goods Administration (TGA) for its AerOs sinus dilation system, designed for the treatment of chronic sinusitis. Designed for use in office-based ...
Tags: SinuSys, Health Canada, Australian Therapeutic Goods Administration
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Medical Modeling's Virtual Surgical Planning (VSP) system product line. The products, which utilize the company's VSP system technology, include VSP Orthognathics ...
Tags: FDA, VSP system product line, US, approval
Tensys Medical's new continuous, non-invasive hemodynamic patient monitoring system has obtained 510(k) clearance from the US Food and Drug Administration (FDA). The TL-300 system, a member of T-Line family, is designed for use in ...
Tags: Hemodynamic Patient Monitor, FDA Approval, TL-300 system
The US Food and Drug Administration(FDA)has granted 510(k)clearance to PhysioSonics'cranial blood flow monitoring system. The Presto 1000 Flow Monitor,which uses the company's proprietary Flash Doppler,maintains the flow of information ...
Tags: FDA, PhysioSonics cranial blood flow monitoring system
The US Food and Drug Administration(FDA)has granted 510(k)clearance to Ascendx Spine's minimally invasive Ascendx VCF Repair system,designed for the treatment of vertebral compression fractures(VCFs). The VCF Repair system,unlike the ...