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MedTech News and Updates for Penumbra, Axonics, Stimwave, SonoScape
Penumbra’s Indigo System; Axonics’s F15 Recharge-free SNS; Stimwave’s FREEDOM-1 Clinical Trial; Virtual Incision’s MIRA Platform; SonoScape’s HD-550 Endoscopy system; SMART Medical’s G-EYE Colonoscope Series

Penumbra launched the Indigo® System with Lightning™ 7 and Lightning 12 Intelligent Aspiration in Europe On April 14, 2022, Penumbra, Inc., a leading medical device company focused on developing innovative therapies for neuro and vascular conditions, received the CE mark for its Indigo Aspiration System w...

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Pharma News and Updates for GSK, BriaCell, Gilead, Lilly, Merck, Halozyme
GSK Acquires Sierra Oncology; BriaCell’s Targeted Breast Cancer Immunotherapy; Merck’s Tepmetko; Gilead’s Magrolimab for MDS and AML; Eli Lilly’s Retevmo; Merck’s Pneumococcal Vaccine; FDA Approves Bevacizumab Biosimilar; Halozyme to Acquire Antares Pharma

GSK Acquires Sierra Oncology for USD 1.9 Billion GlaxoSmithKline has agreed to buy Sierra Oncology and its lead drug assets, momelotinib, for anemia caused by the blood malignancy myelofibrosis. GSK is paying USD 55 per share in cash for Sierra, a 39% premium to the company's closing share price yesterday, valui...

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MedTech News for Alcon, I-VASC, Paige, Truvic, and Alucent
Alcon’s Dry Eye Treatment Device; I-VASC Secures Series A Funding; Paige’s AI Medical Device Software; TRUVIC’s Prodigy Thrombectomy System; Alucent’s Natural Vascular Scaffolding Technology; Guardant Presents Data Supporting Efficacy of Blood Test in Detecting Multiple Cancers

Alcon Announces Launch of Dry Eye Treatment Device On April 04, 2022, Alcon Inc. announced the launch of their latest dry eye innovation, the Systane® iLux2® Meibomian Gland Dysfunction (MGD) Thermal Pulsation System. It is an all-in-one handheld device equipped with new imaging technology to capture infrared ph...

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MedTech News Aidoc, Cook Medical, Corvia, Bioventus, GE, Imeka
Aidoc’s Pneumothorax; Cook Medical’s Zenith Thoraco+ Endovascular System; GRAFIX Membrane Study; Corvia’s REDUCE LAP-HF II Trial Results; GE Healthcare and Imeka’s Collaboration; Bioventus to Acquire CartiHeal

Aidoc Expands AI Service to X-ray, Receiving FDA 510(k) Clearance for Pneumothorax On March 30, 2022, Aidoc, the leading developer of healthcare AI solutions, announced that its triage and notification of pneumothorax on X-ray exams has gained FDA 510(k) approval. Aidoc's other seven FDA-cleared clinical AI prod...

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Pharma News and Updates Precigen, Biogen, Cerevance, Sanofi, Clovis
Precigen’s PRGN-3006; Yescarta Approved as a First CAR T-cell Therapy for R/R LBCL; Biogen & Ionis’ BIIB078; Nobelpharma’s HYFTOR (sirolimus topical gel) 0.2%; Cerevance Parkinson’s Drug; Sanofi & Regeneron’s Dupixent; Clovis’s Rubraca for Ovarian Cancer; Immunocore Eye Cancer Cell Therapy Approval

FDA Approves Yescarta as a First CAR T-cell Therapy for Initial Treatment of R/R Large B-cell Lymphoma Until now, existing CAR-T therapies have been reserved for patients with blood cancer who have tried multiple treatments. The FDA has approved Yescarta, a CD19-directed CAR-T therapy developed by Gilead Science...

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MedTech News for Ypsomed Fresenius Kabi Sientra Synchron HLT
Ypsomed-CamDiab’s Collaboration; Vela Diagnostics’s NGS-Based Pan-Cancer Panels; Fresenius’s SMOFlipid Lipid Injectable Emulsion; Sientra Gained Regulatory Nod to Market Breast Implants; Synchron’s Endovascular BCI Stentrode Device; HLT’s TAVR Clinical Studies

Ypsomed Collaborated with CamDiab for Smartphone-based Automated Insulin Delivery On March 22, 2022, Ypsomed, a leading manufacturer of injection and infusion systems for self-medication partnered with CamDiab Ltd, developer of CamAPS FX, an app for the management of glucose levels via insulin pumps using an ada...

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MedTech News for Smithfield, Cynosure, bioMérieux, Artio Medical, HeartPoint, ObvioHealth
Smithfield BioScience and BioCircuit’s Nerve Tape Device; Cynosure-Jeisys Medical’s Partnership; bioMérieux’s VITEK® MS PRIME new MALDI-TOF Mass Spectrometry Identification System; Artio Medical’s Gold Embolization Device; Heartpoint Global’s Implant System; ObvioHealth’s Virtual Urogynecology Clinical Trial

Smithfield BioScience and BioCircuit to Develop New Nerve Tape Device On March 16, 2022, BioCircuit Technologies, a National Institutes of Health (NIH)-funded medical device company primarily focused on developing and commercializing tissue repair and neural interfacing products, and Smithfield BioScience, a uni...

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Pharma News and Updates for BMS, Biogen, Merck, Moderna, and Takeda
Bristol Myers’ Opdivo combo Opdualag for Melanoma; Biogen’s Aduhelm; Marinus’ Ztalmy for CDKL-5 Deficiency Disorder; Merck’s Keytruda + Lynparza; Vitaris’s Breyna; Moderna’s Second COVID-19 Booster Shot; Takeda’s Exkivity; BMS’s First LAG-3 Checkpoint Inhibitor

NHS Grants Fast Track Access to Takeda’s Exkivity Takeda has secured UK approval for its lung cancer therapy Exkivity, with an NHS access deal that could see it prescribed to patients within the next few weeks. The Medicines and Healthcare products Regulatory Agency has granted conditional marketing authorisa...

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MedTech News and Updates for NeuroLogica, Cordis, OSF Ventures, Rockley Photonics, Medtronic, NovaSight and Cardiawave
NeuroLogica’s OmniTom Elite; Cordis’s S.M.A.R.T. RADIANZ Vascular Stent System; Rockley Photonics and Medtronic’s Collaboration; NovaSight’s Amblyopia Treatment Device; Cardiawave’s VALVOSOFT; OSF Ventures invests in wireless seizure detection sensor

NeuroLogica Announces FDA 510(k) Clearance for Photon Counting Computed Tomography Using OmniTom Elite  On March 10, 2022, The state-of-the-art OmniTom Elite acquired 510(k) approval for the addition of Photon Counting Detector (PCD) technology, according to NeuroLogica Corp, a subsidiary of Samsung Electro...

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pharma news and updates for AstraZeneca, AbbVie, Sandoz, Incyte, Venatorx, and Bayer
AstraZeneca and Merck’s Lynparza; Venatorx’s cefepime-taniborbactam; AbbVie’s Qulipta; AstraZeneca’s IL-5 inhibitor Fasenra; Sandoz Acquires Coalesce; Incyte’s Opxelura; Bayer’s Nubeqa; NICE Rejects Keytruda Plus Chemotherapy

FDA Clears AstraZeneca and Merck’s Lynparza as an Adjuvant Breast Cancer Therapy The FDA approved the AstraZeneca and Merck drug for a specific group of patients with high-risk early breast cancer after chemotherapy treatment, either before or after surgery. Lynparza cements its position as the best-selling PARP...

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