Notizia - Recent Pharma, Healthcare and Biotech Happenings

Centinel Spine’s Prodisc C Match-the-Disc Cervical TDR System; Reflow Medical’s DEEPER OUS Trial; FDA Approval to Endologix’s Detour System; FDA Clearance to Smith+Nephew’s Shoulder Replacement System; SunMed Acquired Avanos’s Respiratory Health Business; BD’s Automate Clinical Flow Cytometry

Centinel Spine® Completed Enrollment in First-of-its-Kind 2-Level IDE Trial Evaluating prodisc® C Match-the-Disc™ Cervical TDR System On June 13, 2023, Centinel Spine®, LLC, a leading global medical device company addressing cervical and lumbar spinal disease by providing the most robust and clinically-proven total disc replacement technology platform in the world, announced the completion of enrollment in a first-of-its-kind Investigational Device Exemption (IDE) study which aims to evaluate the safety and effectiveness of the prodisc C Vivo and prodisc C SK cervical total disc replacement (TDR) system. The trial which enrolled 431 subjects at 29 sites t...

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medtech-news-for-suneva-abiomed-medtronic-endo-tools-diadem

Suneva Medical-Viveon Health merger update; Smith+Nephew acquires Engage Surgical; Abiomed’s preCARDIA technology; Medtronic’s DTM Spinal Cord Stimulation; Endo Tools Therapeutics’s Endomina System; Diadem’s AlzoSure predict prognostic blood test

pharma-news-for-algernon-pieris-gaumard-hekka-labs

Algernon’s NP-120 (ifenprodil); Pieris’s cinrebafusp alfa (PRS-343) clinical trial; Gaumard Scientific’s multidisciplinary patient simulator HAL S5301; Hekka Labs’s decentralized healthcare ecosystem

medtech-news-for-abbott-abiomed-medtronic-alcon-calon-cardio-technology

Leman Micro Devices’ e-Checkup system; Calon Cardio-Technology & Leviticus-Cardio announced Breakthrough; Alcon buys Ivantis; Medtronic to acquire Affera; Abiomed’s Impella 5.5 with SmartAssist; Abbott’s EnSite X EP System with EnSite OT

pharma-news-for-noxxon-nuvalent-stryker-exact-sciences

Noxxon’s NOX-A12 clinical trial; Exact Sciences buys PreventionGenetics; Nuvalent’s clinical trails for NVL-520; Stryker acquires Vocera Communications

medtech-news-for-siemens-paragon-28-pulnovo-endotronix-abbott

Siemens Healthineers’s COVID-19 Antigen Self-Test; Paragon’s R3ACT Stabilization System; Pulnovo Medical’s PADN-CFDA trial; Endotronix’s PROACTIVE-HF trial; Abbott’s Proclaim XR SCS System; RTI Surgical spins off businesses

pharma-news-for-accutar-bio-thera-nykode-heat-biologics-elusys

Accutar’s Phase I clinical trial for AC0176; Bio-Thera’s cancer drug, BAT6005; Nykode’s Covid-19 vaccine trial; Heat Biologics acquires Elusys

medtech-news-for-cerner-scanwell-zynex-envista-sight-sciences

Cerner, Scanwell Health and Personal Genome Diagnostics Acquisition; Zynex’s Fluid Monitoring System, CM-1500; Sight Sciences’ TearCare System; Envista’s Nobel Biocare N1 Implant System

pharma-news-for-biogen-eisai-quidel-accutar-boehringer

Biogen-Eisai’s Aduhelm; Quidel acquires Ortho Clinical Diagnostics; Accutar Biotechnology’s AC0176; Boehringer’s Spesolimab

medtech-news-for-zynex-foldax-bd-ge-edwards

Sky Medical’s Geko™ device; Fist Assist Devices obtains Breakthrough Device designation; Edwards obtains FDA approval; BD launched instrument for testing; GE acquires BK Medical; Zynex’ CM-1500; Foldax’s TRIA biopolymer heart valve

pharma-news-for-edwards-lineage-novartis-koios-medical

Edwards’ Sapien 3 with Alterra Prestent; Koios Medical’s breast, thyroid cancer-spotting AI; Lineage Collaborates with Genentech; Novartis, BeiGene ink deal

medtech-news-for-baxter-medtronic-atacor-brainq

BrainQ’s EMAGINE Trial; AtaCor’s EV-ICD study; Urotronic’s Optilume Urethral Drug-Coated Balloon approval; Medtronic receives 510(k) clearance; Baxter acquires Hillrom

medtech-news-for-boston-scientific-bd-roche-linus-helioliver

Boston Scientific’s MODULAR CRM System; Restore Medical’s ContraBand clinical trial result; BD acquires Venclose; Roche differentiates mutations in Omicron; Linus’s StrandDx-ASD; HelioLiver launches liquid biopsy test

pharma-news-for-aslan-iqvia-reata-recordati-eusa

Aslan Pharma – IQVIA collaboration; Reata’s kidney drug bardoxolone; Alzheimer’s Disease treatment update; Recordati to acquire EUSA

medtech-news-for-lensgen-ge-nevro-hyperfine-immunexpress

LensGen’s Juvene Intraocular Lens; Nevro announces clinical data publications; FDA Clearance to Immunexpress’s SeptiCyte; GE unveils AI and Digital Technologies; Canon launches PIQE DLR and SilverBeam; Hyperfine’s Swoop gets FDA clearance

pharma-news-for-ge-optellum-therapixel-ocugen-blueprint

GE Healthcare-Optellum’s collaboration; Ocugen’s Covid-19 vaccine trial; Blueprint to acquire Lengo Therapeutics; Therapixel’s Mammoscreen

medtech-news-for-neurent-theradaptive-hagar-fujifilm-brain-navi

Neurent Medical’s NEUROMARK; Brain Navi NaoTrac received European CE Mark approval; Theradaptive receives Breakthrough Medical Device Designation; HAGAR GWave awarded Breakthrough Device Designation; Fujifilm launches ColoAssist PRO

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

Suneva Medical-Viveon Health merger update; Smith+Nephew acquires Engage Surgical; Abiomed’s preCARDIA technology; Medtronic’s DTM Spinal Cord Stimulation; Endo Tools Therapeutics’s Endomina System; Diadem’s AlzoSure predict prognostic blood test

Algernon’s NP-120 (ifenprodil); Pieris’s cinrebafusp alfa (PRS-343) clinical trial; Gaumard Scientific’s multidisciplinary patient simulator HAL S5301; Hekka Labs’s decentralized healthcare ecosystem

Leman Micro Devices’ e-Checkup system; Calon Cardio-Technology & Leviticus-Cardio announced Breakthrough; Alcon buys Ivantis; Medtronic to acquire Affera; Abiomed’s Impella 5.5 with SmartAssist; Abbott’s EnSite X EP System with EnSite OT

Noxxon’s NOX-A12 clinical trial; Exact Sciences buys PreventionGenetics; Nuvalent’s clinical trails for NVL-520; Stryker acquires Vocera Communications

Siemens Healthineers’s COVID-19 Antigen Self-Test; Paragon’s R3ACT Stabilization System; Pulnovo Medical’s PADN-CFDA trial; Endotronix’s PROACTIVE-HF trial; Abbott’s Proclaim XR SCS System; RTI Surgical spins off businesses

Accutar’s Phase I clinical trial for AC0176; Bio-Thera’s cancer drug, BAT6005; Nykode’s Covid-19 vaccine trial; Heat Biologics acquires Elusys

Cerner, Scanwell Health and Personal Genome Diagnostics Acquisition; Zynex’s Fluid Monitoring System, CM-1500; Sight Sciences’ TearCare System; Envista’s Nobel Biocare N1 Implant System

Biogen-Eisai’s Aduhelm; Quidel acquires Ortho Clinical Diagnostics; Accutar Biotechnology’s AC0176; Boehringer’s Spesolimab

More Views & Analysis

Sky Medical’s Geko™ device; Fist Assist Devices obtains Breakthrough Device designation; Edwards obtains FDA approval; BD launched instrument for testing; GE acquires BK Medical; Zynex’ CM-1500; Foldax’s TRIA biopolymer heart valve

Edwards’ Sapien 3 with Alterra Prestent; Koios Medical’s breast, thyroid cancer-spotting AI; Lineage Collaborates with Genentech; Novartis, BeiGene ink deal

BrainQ’s EMAGINE Trial; AtaCor’s EV-ICD study; Urotronic’s Optilume Urethral Drug-Coated Balloon approval; Medtronic receives 510(k) clearance; Baxter acquires Hillrom

Boston Scientific’s MODULAR CRM System; Restore Medical’s ContraBand clinical trial result; BD acquires Venclose; Roche differentiates mutations in Omicron; Linus’s StrandDx-ASD; HelioLiver launches liquid biopsy test

Aslan Pharma – IQVIA collaboration; Reata’s kidney drug bardoxolone; Alzheimer’s Disease treatment update; Recordati to acquire EUSA

LensGen’s Juvene Intraocular Lens; Nevro announces clinical data publications; FDA Clearance to Immunexpress’s SeptiCyte; GE unveils AI and Digital Technologies; Canon launches PIQE DLR and SilverBeam; Hyperfine’s Swoop gets FDA clearance

GE Healthcare-Optellum’s collaboration; Ocugen’s Covid-19 vaccine trial; Blueprint to acquire Lengo Therapeutics; Therapixel’s Mammoscreen

Neurent Medical’s NEUROMARK; Brain Navi NaoTrac received European CE Mark approval; Theradaptive receives Breakthrough Medical Device Designation; HAGAR GWave awarded Breakthrough Device Designation; Fujifilm launches ColoAssist PRO

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