medical device
Aug 04, 2022
FDA Clearance to iRhythm’s ZEUS System; Respiri Introduces the Wheezo Device & App; CONMED to Acquire Biorez for $ 85 Million; FDA Clearance to Ambu’s Single-Use Bronchoscope; FDA 510(k) Clearance to Glaukos’s iStent infinite
iRhythm receives FDA clearance for ZEUS System for Zio watch iRhythm Technologies, a leading digital healthcare solutions firm focused on advancing cardiac care, announced that it received FDA 510(k) clearance for the ZEUS (Zio ECG Utilization Software) System for the Zio Watch. It is produced in partnership wit...
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Jul 28, 2022
AbbVie & iSTAR’S Strategic Alliance; Baxter Launches Welch Allyn RetinaVue 100 Imager PRO; Instylla’S Embrace Hydrogel Embolic System; Primary Endpoint Met in the RADIANCE II US Trial; Roche’s Elecsys Amyloid Plasma Panel; EU Approval to Seegene’s Allplex; SARS-CoV-2/FluA/FluB/RSV Assay
ReCor Medical and Otsuka Medical Devices Announce Primary Endpoint Met in the RADIANCE II US Pivotal Trial of the Paradise™ System for the Treatment of Hypertension On July 26, 2022, ReCor Medical, Inc., a completely owned subsidiary of Otsuka Medical Devices Co., Ltd., with its headquarters in Palo Alto,...
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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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Jun 08, 2022
How At-Home Medical Equipment is Improving the Quality of Medical Care?
An essential fact of today's healthcare system is that patients are released from hospitals due to increased stress even when they still need care. As a result, both the patient and professional caregivers utilize various technologies, including some complex mechanisms, in noninstitutional settings to manage their ...
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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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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 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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