news
Nov 09, 2021
Alcon to acquire Ivantis; Philips to takeover Cardiologs; Flunked cancer drug progresses in I-O in pancreatic cancer models; Indigo system CAT RX catheter meets primary endpoint in trial
Alcon to acquire Ivantis for USD 475 Million Alcon announced that it intends to buy glaucoma surgery device maker Ivantis for USD 475 million upfront. Geneva, Switzerland-based Alcon aims to support its portfolio across cataract, refractive, retina and glaucoma offerings by taking over Ivantis and its n...
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Nov 04, 2021
Smith+Nephew’s LEGION CONCELOC; Renew Bioscience’s Cerezen; Perimeter Medical’s ATLAS AI Project; SAGA Diagnostics-AZ’s Deal; Magnus Receives Breakthrough Device Designation; ReValve’s Transeptal Mitral Valve Replacement
ReValve Solutions, Inc. declares successful first human use of the Transeptal Mitral Valve Replacement On November 01, 2021, ReValve Solutions, Inc., a company operating in the field of transcatheter structural heart replacement and repair, announced the successful first human use of its transcatheter, Palmetto...
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Nov 02, 2021
Magnus Medical’s tech gets breakthrough status; Prolacta develops tests for pathogens detection; Renovia gets breakthrough designation for leva system; Hinge Health secures $600M funding
Magnus Medical’s neurostimulation technology gets FDA breakthrough status to treat MDD Magnus Medical has secured a breakthrough device designation from the US Food and Drug Administration (FDA) for its neurostimulation technology for major depressive disorder (MDD) treatment. The individualised, rapid-acting...
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Oct 28, 2021
FDA 510k clearance to Naviswiss’s Naviplan; FDA approved to TYRVAYA; Centinel Spine’s STALIF Integrated Interbody System; Smith+Nephew’s IODOSORB; AlloSource’s AlloMend Extra-Large ADM; SpinaFX and StarFish’s strategic commercialisation contract
Naviswiss secures FDA 510k clearance for Naviplan, an advanced planning solution for hip replacement surgery On October 21, 2021, Naviswiss, a Swiss-based medical technology company, received approval from the FDA to commercialise Naviplan in the United States. Naviplan is a digital pre-operative planning ...
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Oct 26, 2021
Ocular Therapeutix’s insert fails in phase 2; Click Therapeutics raises $52M funding; Roche introduces AVENIO Tumour Tissue CGP Kit; Blue Wolf Capital to acquire CIVCO Radiotherapy
Ocular Therapeutix’s dry eye disease insert fails in phase 2 trial Ocular Therapeutix declared that its OTX-CSI (cyclosporine intracanalicular insert) for dry eye disease (DED) has flunked to reach the primary endpoint in the phase 2 clinical trial. The company has conducted the US-based, randomised, double-m...
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Oct 21, 2021
Hologic to acquire Bolder Surgical; Breakthrough Device Designation to Biological Dynamics; Luminopia declares FDA approval; HistoSonics secures Breakthrough Device Designation; Phillips-Medisize expands worldwide; PolyNovo launches NovoSorb BTM tech
Hologic to acquire Bolder Surgical for USD160 Million, expanding its Surgical Franchise On October 14, 2021, Hologic, Inc., a global player in women's health, signed a definitive agreement to acquire Bolder Surgical. This US-based company offers advanced energy vessel sealing surgical devices for approxima...
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Oct 19, 2021
Biogen’s ALS drug Tofersen (BIIB067); Phathom’s erosive esophagitis drug trial; Vertex’s islet cell therapy; Natera launches lung DNA test
Biogen’s tofersen fails to meet the primary goal in the Phase III ALS trial Biogen has announced that its investigational antisense drug, tofersen (BIIB067), flunked to meet the primary goal of Phase III VALOR clinical trial in superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS) patients. Althou...
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Oct 14, 2021
Bausch + Lomb’s LuxSmart Intraocular Lenses; Movair’s Luisa Life Supporting Ventilator; Cochlear’s Nucleus and Baha Systems; Laborie Acquires Pelvalon; Know Labs’s SARS-CoV-2 Research; Syntellix’s MAGNEZIX;
Syntellix obtains product approval for India On October 07, 2021, Syntellix obtained the license to bring five different product families of its revolutionary bioabsorbable magnesium-based implants to market from India's Central Drugs Standard Control Organisation (CDSCO) for the Indian market. With this approva...
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Oct 12, 2021
Brickell to Submit New Drug Application to FDA; Twin Health Raises $140M; BMS’ Deucravacitinib; Lando Biopharma’s LABP-104 gets Approval; NIH Grant of $ 3 M to Amydis; FDA Grant to GenSight’ GS030
Brickell Plans to Submit New Drug Application to FDA for gel Brickell Biotech will request the FDA in mid-2022 to approve its gel for excessive underarm sweating after decreasing sweat production and disease severity in two pivotal trials. The gel achieved statistical significance in lessening the sever...
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Oct 07, 2021
Amber Implants VCFix spinal system; iotaMotion’s iotaSOFT Insertion System; Boston Scientific acquires Baylis; ReCor’s Paradise Ultrasound Renal Denervation; Boston Scientific’s Ranger Drug-Coated Balloon; Natera’s Prospera
Amber Implants VCFix® spinal system obtains US FDA Breakthrough designation On October 05, 2021, the US Food and Drug Administration (FDA) granted the Breakthrough Device Designation to VCFix® spinal system, a next-generation spinal implant for spinal injuries developed by Amber Implants, a Netherlands-bas...
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