SpineGuard has received 510(k) clearance from the US Food and Drug Administration (FDA) for three new products, designed to enhance pedicle screw penetration of small and/or difficult-to-access pedicles. The two miniaturized versions of ...
Tags: Pediguard Products, SpineGuard
Medical device company LDR has received approval from the US Food and Drug Administration (FDA) for commercial sale and distribution of its Mobi-C Cervical Disc (Mobi-C), for two-level indications in the US. The Mobi-C is designed for ...
Tags: Medical device, LDR
Australia-based Allied Healthcare Group has received CE mark approval for its lead regenerative product called CardioCel, which is used in treating congenital heart disease and repairing heart valves. The approval will help the company to ...
Tags: Cardiocel, CE Mark Approval
Surgical products developer Zimmer Holdings has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its Patient Specific Instruments (PSI) Shoulder system. The system enables surgeons to plan the implant ...
Tags: Shoulder System, Surgical products
Abbott has completed its acquisition of Idev Technologies, a privately held firm that manufactures next-generation medical devices for use by interventional radiologists, vascular surgeons and cardiologists, for $310m. Abbott believes ...
Tags: Abbott, Idev Technologies
Oasis Medical, a US-based manufacturer and distributor of high quality disposable surgical instruments and ocular lubricating and cleansing solutions, has launched its new 6.25mm Oasis Iris Expander for pupil dilation and sustaining ...
Tags: Oasis Medical, Medicine
CoAlign Innovations, a US-based medical device company, has received the US Food and Drug Administration (FDA) approval for its AccuLIF XL lateral expandable interbody fusion devices. The new AccuLIF interbody system utilizes low-profile ...
Northwestern's Bluhm Cardiovascular Institute has recently enrolled first patient in ABSORB III, a clinical trial to compare the performance of Abbott's drug eluting Absorb Bioresorbable Vascular Scaffold (BVS) device with other traditional ...
Tags: Absorb device, Medicine
c has submitted 510(k) application to the U.S. Food and Drug Administration (FDA) for marketing clearance of its MicroCutter XCHANGE 30, a cutting and stapling device designed to be used in multiple open and minimally invasive surgical ...
Tags: Microcutter Device
Century Medical, a Japanese medical device distributor, has sought clearance from the country's Pharmaceuticals and Medical Devices Agency (PMDA) for Cardica's MicroCutter XCHANGE 30 cutting and stapling cartridge, which is intended for ...
IMRIS has obtained CE mark for its specialized multifunctional surgical theater called VISIUS iCT, designed for spinal and neurosurgical needs. Claimed to be the first ceiling-mounted intraoperative CT solution available in the market, ...
Tags: CE Mark, CT Solution
The US Food and Drug Administration (FDA) Ophthalmic Devices Advisory Panel is scheduled to decide on Ocular Therapeutix’s premarket approval application for the ReSure Sealant in September and may suggest some recommendations. ...
Tags: Ophthalmic Devices, Health
A non-profit organization is publishing a quick-reference card to help cycling teams and race officials assess possible concussions. The group, Medicine of Cycling, has collaborated with a group of physicians and researchers with a ...
Tags: Transportation, bike
Sealantis has received the CE Mark for its vascular sealant called Seal-V, a protein-free, safe, bio-compatible, and bio-resorbable vascular sealant designed for surgical reconstruction of large blood vessels such as the carotid, femoral, ...
Tags: CE Mark
Integra LifeSciences has received US regulatory clearance to market its Integra Titan Reverse Shoulder System, which offers greater flexibility for shoulder replacement surgery. The company plans to begin a limited market release in the ...
Tags: Integra Lifesciences