news
Jul 07, 2022
Collagen Matrix FDA 510(k) approval for Fibrillar Collagen Wound Dressing; Roche’s cancer diagnostics ULTRA PLUS system launch; Insightec IDE Approval for Prostate Cancer; JustLight plc. trial of Sunflower Rx for Alzheimer’s disease; Thoraflex Hybrid Device Implantation in the United States; FDA 510(k) Clearance for the DABRA 2.0 Catheter
Collagen Matrix received FDA 510(k) approval for Fibrillar Collagen Wound Dressing On June 29, 2022, Collagen Matrix, Inc., a leader in regenerative medicine, a global manufacturer of collagen and other biomaterial-based medical devices, and Linden Capital Partners portfolio company announced FDA 510(k) Clearan...
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Jun 23, 2022
CE Mark to Ibex’s Gastric Cancer Detection System; Senseonics’s Eversense E3 Continuous Glucose Monitoring System; NEUSPERA’s NUVELLA SYSTEM; Conformal Medical Initiates CONFORM Pivotal Trial; Meridian Launches New qPCR Master Mixes for Stool Samples; Sentinel Diagnostics Launches SENTiFIT 800
Conformal Medical Announces Launch of CONFORM Pivotal Trial On June 17, 2022, Conformal Medical Inc, is a medical device company manufacturing devices to avoid strokes in patients with non-valvular atrial fibrillation and developing next-generation LAAO technology. Its exclusive technology is intended to make le...
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May 31, 2022
Bristol-Myers Squibb’s Opdivo Approval; Mirati’s KRAS-inhibitor Adagrasib; J&J and Legend Biotech’s CAR-T Carvykti Approval; Roche’s Glofitamab; Arena Pharma’s Etrasimod Phase 3 Trials; FDA Approves Dermavant’s Vtama; FDA Approves Novartis’ Cell Therapy; NICE Approves Merck’s Keytruda
Bristol-Myers Squibb’s Opdivo Gets FDA Approval for Esophageal Cancer The FDA has approved two combination drug regimens based on Bristol-Myers Squibb’s PD-1 inhibitor Opdivo for previously untreated advanced Esophageal Cancer, encroaching on the territory belonging to Merck & Co’s rival Keytruda. The latest...
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May 26, 2022
Accleus’s Toro-L Interbody Fusion System; Labcorp’s New Test for Skin Cancer; SERA Prognostics’s Preterm Test; Endotronix’s SIRONA 2 Clinical Trial; Anumana’s AI Algorithm to Detect ECG Pulmonary Hypertension; Illumina’s Pan-cancer Companion Diagnostic
Accleus Receives Regulatory Approval from US FDA for Toro-L Interbody Fusion System On May 19, 2022, the US Food and Drug Administration (FDA) granted the regulatory approval to Toro-L interbody fusion system developed by Accleus. The device is a biplanar expandable lateral implant designed for a minimal inserti...
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May 19, 2022
Check-Cap’s Pivotal Trial for C-Scan; Curebase and Flow Neuroscience’s tDCS Device; Brainlab Acquires Majority Share in medPhoton; GE Healthcare to Invest in Pulsenmore; Medtronic’s Drug-Eluting Coronary Stent System; Remedee’ Endorphin Stimulation Solution;
Check-Cap Initiated the US Pivotal Trial for C-Scan® On May 11, 2022, Check-Cap Ltd., a clinical-stage diagnostic company initiated the US pivotal trial for C-Scan® at Mayo Clinic in Rochester Minnesota. C-Scan is the first and only patient-friendly, preparation-free screening test to detect polyps before they m...
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May 17, 2022
BMS Sells NY Biologics Plant; FDA Approves Mitsubishi Tanabe’s Radicava, Love Pharma Acquires MicroDoz; Sandoz Launches Generic of Roche’s Esbriet; Pfizer to Acquire Biohaven Pharma; eureKARE’s Cell and Gene Therapy CDMO; Atamyo’s LGMD Gene Therapies; FDA approves Eli Lilly’s Type 2 Diabetes Treatment
Love Pharma Completes the Acquisition of MicroDoz Therapy LOVE Pharma Co. has announced the completion of its acquisition of MicroDoz Theraphy Inc. ("MicroDoz"). Love Pharma holds exclusive manufacturing, marketing, packaging, selling, and distribution licenses in Europe, the United Kingdom, and North America. U...
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Apr 21, 2022
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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Apr 19, 2022
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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Apr 14, 2022
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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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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