MedTech News
Sep 01, 2022
Miracor Medical’s Picso Pivotal Study; Medtronic’s Extravascular ICD; Galaxy Medical’s CENTAURI Pulsed Electric Field System; UltraSight’s Novel Cardiac AI Technology; Oticon Launched the World’s Smallest Hearing Aid; Medtronic Completes Acquisition of Affera
FDA Approved IDE for Picso® Pivotal Study of Miracor Medical On August 23, 2022, Miracor Medical SA, a provider of innovative solutions for the treatment of severe cardiac diseases, announced that the FDA has approved an Investigational Device Exemption (IDE), allowing the company to begin a pivotal study with i...
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Aug 25, 2022
Edwards’s Pascal Precision System; Abbott’s New Spinal Cord Stimulation Device; Imagin to Acquire enCAGE Coil Precision Ablation System; Boston Heart Diagnostics Launches LipidSeqTM; Rocket VR Health Partners with Penn Medicine’s Abramson Cancer Center; Thermedical’s Clinical Trial to Treat Ventricular Tachycardia
Edwards Pascal Precision Transcatheter Mitral And Tricuspid Valve Repair System Receives CE Mark On August 17, 2022, Edwards Lifesciences Corporation, an American medical technology company headquartered in Irvine, California, specializes in artificial heart valves and hemodynamic monitoring. The company announc...
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Aug 18, 2022
CereVasc’s eShunt System Study; FDA Approves NGS-Based CDx for Trastuzumab Deruxtecan; Nanopath Secures $10 Million Funding; BD, Accelerate Diagnostics Announce Collaboration; Avails Medical’s Clinical Trials for eQUANT; Movano Ring Exceeds Accuracy Targets for SpO2 & Heart Rate Monitoring
CereVasc Announces FDA Approval of Second IDE Study of the eShunt® System On August 09, 2022, CereVasc, Inc., a privately held, clinical-stage medical device company developing novel, minimally invasive treatments for neurological diseases, announced that the U.S. Food and Drug Administration (FDA) has approved ...
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Aug 11, 2022
Rapid Medical’s TIGERTRIEVER 13; Glaukos’s Istent Infinite System; GE Healthcare’s Definium 656 HD; NeuroOne’s Signed Exclusive Development & Distribution Agreement with Zimmer; Kaia Health’s Rise-uP Randomized Controlled Trial; Bluejay’s Symphony IL-6 Test
Rapid Medical Obtains FDA Clearance for the World's Smallest and Only Adjustable Thrombectomy Device On July 26, 2022, Rapid Medical, a leading developer of advanced neurovascular devices, received Food and Drug Administration (FDA) 510(k) clearance for TIGERTRIEVER™13 for large vessel occlusions.&n...
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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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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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