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Showing 20 results out of 10000

NeoTract obtains FDA de novo clearance for prostate implant

US-based NeoTract has received the US Food and Drug Administration (FDA) authorisation to market UroLift system, which is the first permanent implant designed to relieve low or blocked urine flow in men age 50 and older with enlarged prostates.

Regentis Biomaterials’ knee cartilage repair technology shows impressive recovery rates

Regentis Biomaterials, a tissue repair company, has announced new clinical data demonstrating the efficacy and safety of its GelrinC implant, designed for the treatment of articular cartilage in injured knees.

Vital Access obtains FDA clearance for vascular needle guide

US-based Vital Access has obtained the US Food and Drug Administration (FDA) market clearance for its patented VWING vascular needle guide to provide vascular access for haemodialysis treatment.

Boston Scientific reports positive six-month results from Lotus valve system study

US-based medical device manufacturer Boston Scientific has reported positive six-month results from the first 60 patients enroled in the REPRISE II clinical trial, designed to evaluate the safety and performance of the Lotus valve system in symptomatic patients with severe aortic stenosis considered at high-risk for surgical valve replacement.

Abbott secures CE Mark for blood glucose and ketone monitoring system

US-based Abbott has received CE Marking in Europe for the FreeStyle Optium Neo blood glucose and ketone monitoring system, designed to track glucose trends and log insulin, which may help improve the patient's daily management of diabetes.

AngioDynamics secures Health Canada approval for tip location system

US-based AngioDynamics has announced that its distribution partner, Medcomp, has received Health Canada approval for the Celerity tip location system, designed to be used as an alternative to chest X-ray and fluoroscopy for peripherally inserted central catheter (PICC) tip placement in adult patients.

Ventana and Boehringer Ingelheim to develop companion diagnostic tests for oncology programmes

Ventana Medical Systems (Ventana), a member of the Roche Group, has signed a collaboration agreement with a German pharmaceutical group Boehringer Ingelheim to develop companion diagnostic tests for Boehringer's oncology programmes.

Crosstrees Medical secures FDA 510(k) approval for its PVA pod system

US-based Crosstrees Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) for the Crosstrees PVA Pod System, designed to control bone cement delivery and decrease the risk of PMMA leakage associated with vertebroplasty and kyphoplasty, the standard surgical treatments for vertebral compression fractures.

Sapheon submits first 'PMA' module for VenaSeal closure system

US-based Sapheon has submitted its first pre-market approval (PMA) module to the US Food and Drug Administration (FDA) for VenaSeal sapheon closure system, which is designed for the treatment of varicose veins caused by venous reflux disease.

Ocular Therapeutix secures favourable votes from FDA panel for post-surgical sealant

US-based Ocular Therapeutix has secured favourable votes from the ophthalmic devices panel of the Food and Drug Administration (FDA) for its ReSure sealant, a hydrogel designed for intraoperative management of clear corneal incisions with a wound leak following cataract or intraocular lens placement surgery.

Given Imaging secures Japanese clearance for next-generation PillCam SB system

Israel-based medical devices developer Given Imaging has received clearance from the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan for its third-generation video capsule PillCam SB3 to detect and monitor small bowel illnesses such as Crohn's disease.

FDA releases final guidance governing mobile medical apps

The US Food and Drug Administration (FDA) has issued final guidance concerning the regulation of mobile medical applications that have the potential to harm consumers if they do not function correctly.

Luminex secures FDA and European approval for personalised medicine genotyping assay

a US-based biotechnology company Luminex has received the US Food and Drug Adminstration and European approval for a comprehensive genotyping assay, xTAG CYP2C19 kit, an in vitro diagnostic test used as an aid to clinicians.

Medtronic secures FDA approval for self-expanding stent for use in lower extremities

Medtronic has obtained the US Food and Drug Administration (FDA) approval to market its Complete SE (self-expanding) vascular stent, designed for use in lower extremities, including superficial femoral arteries (SFA) and proximal popliteal arteries (PPA).

Oraya Therapeutics reports positive two-year results from INTREPID study

Oraya Therapeutics has reported positive two-year results from its INTREPID study, designed to evaluate the safety and efficacy of the IRay stereotactic radiotherapy system for the treatment of wet age-related macular degeneration (AMD).

Stryker to acquire Mako Surgical for $1.65bn

US medical equipment manufacturer Stryker has signed a definitive agreement to acquire Mako Surgical, developer of robotic solution and implants for minimally invasive orthopaedic procedures, for $30 per share with an aggregate purchase price of approximately $1.65bn.