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Biosensors International Group Ltd.

Medtech manufacturers must add warning label to drug-eluting PAD devices

June 16, 2020 By Nancy Crotti

UK medtech regulators on Monday announced that manufacturers of paclitaxel-eluting balloons for use in peripheral arteries must add a warning label about the devices’ risks. A meta-analysis published in the Journal of the American Heart Association in 2018 suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for […]

Filed Under: Business/Financial News, Drug-Device Combinations, Drug-Eluting Stents, Featured, Regulatory/Compliance, Stents, Vascular Tagged With: B. Braun, Biosensors International Group Ltd., Biotronik, Boston Scientific, Cook Medical, FDA, Lutonix Inc., LVD Biotech, Medtronic, Spectranetics Corp., U.K.medicinesandhealthcareproductsregulatoryagency

TCT 2019: Medtronic’s Resolute Onyx non-inferior to Biosensors Biofreedom stent

September 27, 2019 By Brad Perriello

A study comparing the Resolute Onyx drug-eluting stent from Medtronic (NYSE:MDT) and the BioFreedom stent made by Biosensors International (PINK:BSNRY) showed the Medtronic device to be non-inferior in patients on a one-month dual anti-platelet therapy regimen, according to results presented yesterday at the annual Transcatheter Cardiovascular Technologies conference in San Francisco. Medtronic launched the 2,000-patient study […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Eluting Stents, Featured Tagged With: Biosensors International Group Ltd., Medtronic, TCT 2019

Statistical error reverses noninferiority finding in head-to-head trial of DES, bioresorbable scaffold

December 4, 2018 By Sarah Faulkner

In a reversal, investigators for a trial comparing Biotronik‘s bioresorbable, drug-eluting Orsiro stent and Biosensors‘ BioFreedom drug-eluting stent reported this week that Biosensors’ device did not meet the criteria for noninferiority. The researchers said that while preparing the study for publication in a journal, they discovered a statistical error that ultimately changed the trial’s conclusion. The results […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Pharmaceutical, Vascular Tagged With: Biosensors International Group Ltd., Biotronik

Biosensors International launches US pivotal for BioFreedom DCS

March 23, 2017 By Fink Densford

Biosensors International said today it enrolled the 1st patient in a pivotal US study of its BioFreedom drug-coated stent. The Singapore-based company’s Leaders Free II study is an ongoing trial examining the use of the BioFreedom DCS in patients at high bleeding risk who receive an ultra-short dual anti-platelet drug regimen of 1 per month. “We […]

Filed Under: Clinical Trials, Stents Tagged With: Biosensors International Group Ltd.

Cardinal Health’s Cordis gets back in the drug-eluting stent game with Biosensors deal

May 12, 2016 By Brad Perriello

Cardinal Health (NYSE:CAH) said today that its Cordis subsidiary is getting back into the drug-eluting stent game via an overseas distribution agreement with Biosensors International (PINK:BSNRY). The deal calls for Cordis to sell the BioFreedom, BioMatrix NeoFlex, BioMatrix Alpha and Chroma stents made by Biosensors in Europe, the Middle East, Australia and New Zealand. Cordis said it plans to gradually […]

Filed Under: Cardiovascular, Distribution, Stents Tagged With: Biosensors International Group Ltd., Cardinal Health, Cordis Corp.

Biosensors’ new CEO is Abbott, Guidant vet | Personnel Moves

June 2, 2014 By Brad Perriello Leave a Comment

Biosensors' new CEO is Abbott, Guidant vet | Personnel Moves

Filed Under: News Well Tagged With: Biosensors International Group Ltd., Personnel Moves

Biosensors lands FDA OK to launch U.S. trial of drug-eluting stent

May 6, 2014 By Arezu Sarvestani Leave a Comment

Biosensors lands FDA OK to launch U.S. trial of drug-eluting stent

Filed Under: Drug-Eluting Stents, Food & Drug Administration (FDA), News Well, Regulatory/Compliance, Stents Tagged With: Biosensors International Group Ltd., Clinical Trials, Investigational Device Exemption (IDE)

Biosensors lowers guidance on weakness in stent market

November 12, 2013 By Arezu Sarvestani Leave a Comment

Biosensors lowers guidance on weakness in stent market

Filed Under: Drug-Eluting Stents, MassDevice Earnings Roundup, News Well, Stents, Wall Street Beat Tagged With: 2013, Biosensors International Group Ltd., Q3

Abbott, Boston Scientific pay almost no taxes in Ireland despite billions in profits | Wall Street Beat

May 31, 2013 By Brad Perriello Leave a Comment

MassDevice.com Wall Street Beat

Filed Under: Food & Drug Administration (FDA), Funding Roundup, Mergers & Acquisitions, News Well, Wall Street Beat Tagged With: Abbott, Biosensors International Group Ltd., Boston Scientific, BTG, defensedepartment, Digirad Corp., Ekos, Exports, InVive Corp., Philips, Scanadu, Spectrum Dynamics

Biosensors International wins CE Mark for latest line of drug-eluting stents

May 20, 2013 By Sony Salzman Leave a Comment

Biosensors

Biosensors International (PINK:BSNRY) said it won a green light from European regulators for its BioMatrix NeoFlex drug-eluting stent, the latest in its DES line.

Filed Under: News Well, Regulatory/Compliance, Stents Tagged With: Biosensors International Group Ltd.

Stung by widening losses, Accuray plans $75M debt offering | Wall Street Beat

February 7, 2013 By MassDevice staff Leave a Comment

MassDevice.com Wall Street Beat

Accuray (NSDQ:ARAY) plans to issue $75 million worth of convertible senior notes as it gears up to restructure its business after a year of widening losses.

The Sunnyvale, Calif.-based medical device company said it will use the proceeds from the offering of debt due Feb. 1, 2018, to shore up its balance sheet.

Filed Under: Funding Roundup, MassDevice Earnings Roundup, News Well, Radiosurgery/Radiation therapy, Wall Street Beat Tagged With: Accuray Inc., Biosensors International Group Ltd., InspireMD, Micro Interventional Devices, Safeguard Scientifics Inc., Sotera Wireless, Terumo

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