news
Apr 07, 2022
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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Apr 05, 2022
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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Mar 31, 2022
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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Mar 24, 2022
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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Mar 22, 2022
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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Mar 17, 2022
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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Mar 15, 2022
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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Mar 10, 2022
Bioventus’s StimRouter Pain Management Device; FDA Approval for eCoin Therapy; SurGenTec Launches ION Screw; Exactech’s Humeral Reconstruction Prosthesis; Boston Scientific’s WATCHMAN FLX LAAC Device; PathMaker Neuro’s MyoRegulator
Bioventus Receives 501(k) Clearance for StimRouter Pain Management Device On March 1, 2022, the US Food and Drug Administration (FDA) gave Bioventus' StimRouter Neuromodulation System 510(k) approval. The next-generation pain treatment device is intended to treat chronic pain caused by peripheral nerves, ex...
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Mar 08, 2022
Lilly & Boehringer’s Jardiance; BMS Secures a Neoadjuvant Market for Opdivo; Amgen & NHS Signs a Deal; Roche’s Alzheimer Drug gantenerumab; Pfizer’s RSV Vaccine; Civica’s Insulin Biosimilars; Eli Lilly & Incyte’s JAK inhibitor Olumiant; Natco Pharma Launches Revlimid Generic
Eli Lilly, Boehringer Ingelheim’s Jardiance Giving Competition to AstraZeneca’s Farxiga with EU Approval Jardiance, the diabetes blockbuster from Eli Lilly and Boehringer Ingelheim, recently received a Heart Failure label expansion in the United States. Now, the drug is expanding into Europe, with a nod that mig...
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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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