news
Mar 03, 2022
Noninvasix’s LIVOx™ Central Venous Oxygenation Monitor; LivaNova’s aura6000 System; Oxford BioDynamics’s EpiSwitch® CiRT; Masimo’s SedLine® Brain Function Monitoring and the SedLine Pediatric EEG Sensor; Medtronic’s NuVent™ Eustachian Tube Dilation Balloon; Conformis’s published data for Bilateral Knee Implant Study
Noninvasix Granted the US FDA Breakthrough Device Designation for Non-Invasive Monitoring Technology for Sepsis On February 23, 2022, Noninvasix, Inc. received the US FDA breakthrough device designation for its LIVOx™ Central Venous Oxygenation Monitor. It is a non-invasive device and provides real-time, ...
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Mar 01, 2022
GSK’s Covifenz; Idorsia’s Quviviq; GSK’s ZEJULA; EMA Expands its Nod for BMS, Eli Lilly, and Novartis Drugs; Cantex Secures Global Licence to Develop Azeliragon; Biocon Acquires Viatris’ Biosimilar Business
GSK’s Covifenz, A Plant-Based COVID Vaccine, Receives First Approval The recombinant COVID-19 vaccine developed by Medicago, now known as Covifenz, has received approval in Canada, the company's home country. Covifenz employs Coronavirus-Like Particle (CoVLP) technology, with the vaccine consisting of recombinan...
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Feb 24, 2022
Motus GI’s Pure-Vu EVS System; EvoEndo’s Single-Use Unsedated TNE System; Orthofix’s OpusTM BA; Invitae’s CE-IVD Cancer Testing Kits; PolyActiva’s PA5108 Ocular Implant; Ra Medical’s DABRA excimer laser system
US FDA grants 510(k) clearance to Motus GI’s Pure-Vu EVS System On February 15, 2022, The Pure-Vu® EVS System received 510(k) clearance from the US Food and Drug Administration, according to Motus GI Holdings, Inc., a medical technology company that provides endoscopy solutions that improve clinical outcomes and...
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Feb 22, 2022
Sandoz’s Generic Revlimid; Agios’ Pyrukynd; Organon Announces 4Q & Full-year Earnings Report; BMS’ CAR-T Drug Breyanzi; Sanofi & Regeneron’s Dupixent Trial; AZ & Daiichi’s Drug Enhertu; Bayer’s Drug Kerendia; Lilly Releases Mirikizumab Data
Sandoz Launches generic Revlimid in 19 European Countries, Bringing a Flood of Competition to BMS' Megablockbuster Since Bristol Myers Squibb acquired Celgene and its megablockbuster Revlimid, the company has been bracing for the day when the multiple myeloma superstar would face generic competition. Sandoz, a s...
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Feb 17, 2022
Össur Launches POWER KNEE; DePuy Synthes Acquires CrossRoads Extremity Systems; Myomo’s MyoPro; Accuray’s TomoTherapy System; Theradaptive’s Spinal Fusion Implant; Senseonics’s Eversense E3 CGM System
Össur Launches World’s Actively Powered Lower Limb Bionic Prosthesis- New Power Knee for Amputees On February 09, 2022, Össur announced the launch of the new POWER KNEE, the first actively powered microprocessor-based prosthetic knee in the world. This device is aimed at treating patients with above-knee amputat...
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Feb 10, 2022
Stryker’s Tornier Shoulder Arthroplasty; Genesis Acquires JC Medical; FDA Clearance to Single-Use Gastroscope; BioCardia’s CardiAMP Cell Therapy System; Abbott’s Dual-Chamber Leadless Pacemaker; atHeart’s ASCENT ASD U.S. IDE
BioCardia Receives FDA Breakthrough Device Designation for CardiAMP Cell Therapy System for Heart Failure On February 03, 2022, The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the CardiAMP® Cell Therapy System for the treatment of heart failure, according to BioCardia®, ...
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Feb 08, 2022
Biogen’s Aduhelm; FDA Approves Sanofi’s Enjaymo; NHS & Orchard Signs a Deal; Bristol’s Breyanzi & Abecma; Pharming’s Leniolisib; Eli Lilly’s Verzenio Trial; UCB’ Zilucoplan Trials Result; Eli Lilly’s Alzheimer’s Drug Donanemab
Biogen's Aduhelm Marketing and Approval are Under Scrutiny in New FTC and SEC Investigations Biogen can't seem to get a break when it comes to the Alzheimer's disease drug Aduhelm. Along with limited sales and a constraining Medicare coverage plan, the medicine is now facing additional scrutiny as part of a pair...
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Feb 03, 2022
Insulet’s Omnipod 5 Automated Insulin Delivery System; Alivecor’s KardiaMobile Card; BD Board Approved the Spinoff of embecta; Medtronic’s Hugo Surgery Robot; Artivion’s On-X® Mitral Heart Valve PROACT; OmnySense’s Smart Thermometer Clinical Trial
Insulet Received FDA Clearance for its Omnipod® 5 Automated Insulin Delivery System, First Tubeless System with Smartphone Control On January 28, 2022, Insulet Corporation, a market leader in developing tubeless insulin pumps with its product, Omnipod®, received the FDA approval for its Omnipod® 5 Automated Insu...
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Feb 01, 2022
Immunocore’s Kimmtrak; Samsung Acquires Biogen’s Biosimilar Unit; Novavax’s COVID-19 Vaccine; CHMP Approves Dupixent (dupilumab); Glenmark’s High Blood Pressure Treatment; Roche’s Faricimab; GBT’s Voxelotor
Immunocore Receives FDA Approval for the First Uveal Melanoma Treatment, As Well As the First T-cell Receptor Therapeutics Uveal Melanoma, an aggressive eye cancer, has proven to be a tough nut to crack for researchers seeking a cure. However, with the approval of a new treatment, those with the disorder will ha...
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Jan 27, 2022
Fluidx Medical’s GPX Embolic Device; Cardiovascular Systems & OrbusNeich’s Scoreflex Scoring Balloon; BENDIT’s BENDIT21 Neuro Catheter; Cook Medical Drug-eluting Stent; Zimmer Biomet’s Spinoff; Smith+Nephew’s PICO 7 and PICO 14 System
GPX Embolic Device Success in Challenging Tumor Case On January 20, 2022, In a multi-center clinical study, Fluidx Medical's GPX Embolic Device was utilized to efficiently devascularize a massive tumor with several feeding vessels. The GPX Embolic Device is a cutting-edge embolic device that allows for easy prep...
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