Guardant Health Secures the US FDA Approval for Guardant360 CDx as a Companion Diagnostic for Pfizer’s Braftovi

Shots: The US FDA has approved Guardant360 CDx as a companion diagnostic to identify pts with BRAF V600E-mutant metastatic colorectal cancer who may benefit from treatment with Pfizer’s Braftovi (encorafenib) + cetuximab & CT Accelerated approval was backed by P-III (BREAKWATER) trial assessing encorafenib + cetuximab & CT vs SoC, in which Guardant360 CDx, a non-invasive genomic…

ByRidhi Rastogi3 days ago

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CereVasc Completes Patient Enrolment in ETCHES 1 Study of eShunt System for Communicating Hydrocephalus

Shots: CereVasc completed enrollment in the ETCHES-1 Study evaluating its eShunt System in adults with communicating hydrocephalus resulting from elevated intracranial pressure following post-aneurysmal subarachnoid hemorrhage Study will assess changes in intracranial pressure, device performance & safety, with pts monitored for safety outcomes for up to 24mos. following the procedure eShunt System is designed to…

ByRidhi Rastogi4 days ago

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Trisol Medical Reports US Early Feasibility Study Results on Transcatheter Tricuspid Valve Replacement (TTVR) System

Shots: The US Early Feasibility Study assessed TTVR system in 22 pts with severe to torrential tricuspid regurgitation; enrollment in the trans-jugular cohort is complete, with the study continuing via Trisol’s newly developed trans-femoral access route Safety outcomes showed <5% permanent pacemaker need at 30 days, with considerable reduction in tricuspid regurgitation following implantation At 30 days…

ByRidhi Rastogi4 days ago

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SurGenTec Receives the US FDA Clearance for ION-C Facet Fixation System

Shots: The US FDA has granted clearance to ION-C Facet Fixation System, part of SurGenTec’s posterior cervical platform, for the treatment of cervical pseudoarthrosis Clearance was supported by IRB-approved long-term study data showing bridging bone across facet joints with no reported AEs, implant migration, or revision surgeries, & postoperative imaging confirming preserved cervical alignment &…

ByRidhi RastogiJanuary 21, 2026

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Abbott Secures European CE Mark for TactiFlex Duo Ablation Catheter to Treat Atrial Fibrillation

Shots: Abbott has reported CE Mark approval of TactiFlex Duo Ablation Catheter, Sensor Enabled to treat pts with atrial fibrillation (AF) Approval was based on the global FOCALFLEX CE Mark study assessing TactiFlex Duo, which showed clinically meaningful efficacy & favorable safety in the AF pts Also being evaluated in the FLEXPULSE IDE trial in the…

ByRidhi RastogiJanuary 21, 2026

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BD’s EnCor EnCompass System Secures the US FDA 510(k) Clearance for Breast Biopsy

Shots: The US FDA has granted 510(k) clearance for the EnCor EnCompass Breast Biopsy and Tissue Removal System to provide clinicians with flexibility across breast imaging modalities in the diagnosis of breast disease The EnCor EnCompass Biopsy System streamlines breast biopsy procedures by allowing clinicians to use a single integrated system across multiple imaging platforms,…

ByRidhi RastogiJanuary 16, 2026

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Boston Scientific to Acquire Penumbra for ~$14.5B

Shots: Boston Scientific has entered into a definitive agreement to acquire Penumbra, expanding its cardiovascular portfolio As per the deal, Boston Scientific will acquire Penumbra for $374/share, with Penumbra stockholders having the option to receive either $374 in cash or 3.8721 shares of Boston Scientific’s common stock, representing the enterprise value of ~$14.5B; closing expected…

ByDipanshu DixitJanuary 16, 2026

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Medtronic Reports 510(k) Clearance of MiniMed Go System for Diabetes Management

Shots: FDA has granted 510(k) clearance to MiniMed Go app, powering the MiniMed Go Smart MDI system that integrates the InPen smart insulin pen with Abbott’s Instinct glucose sensor for diabetes management; commercial launch expected in spring of 2026 The MiniMed Go system is cleared for people with insulin-requiring type 1 & type 2 diabetes…

ByRidhi RastogiJanuary 13, 2026

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RefleXion Medical Reports the US FDA Clearance of RefleXion X2 Platform for Improved Tumor Detection

Shots: The US FDA has cleared RefleXion X2 with SCINTIX therapy for the treatment of primary & metastatic lung & bone tumors X2 platform provides a 20-fold increase in PET sensitivity, increasing detectable biological signal levels for tumor imaging & potentially broadening the population eligible for SCINTIX therapy based on imaging criteria Its wide field-of-view PET detector…

ByRidhi RastogiJanuary 9, 2026

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Saluda Medical Reports CE Mark Approval of EVA Sensing Technology for Personalized Pain Management

Shots: Saluda Medical has reported the European CE Mark approval of its EVA Sensing Technology to manage pain with spinal cord stimulation, with recognition of this approval in Australia The company is planning a limited commercial launch in EU & Australia for Q1’26, followed by a full commercial rollout in both regions later in the…

ByRidhi RastogiJanuary 9, 2026

Guardant Health Secures the US FDA Approval for Guardant360 CDx as a Companion Diagnostic for Pfizer’s Braftovi

CereVasc Completes Patient Enrolment in ETCHES 1 Study of eShunt System for Communicating Hydrocephalus

Trisol Medical Reports US Early Feasibility Study Results on Transcatheter Tricuspid Valve Replacement (TTVR) System

SurGenTec Receives the US FDA Clearance for ION-C Facet Fixation System

Abbott Secures European CE Mark for TactiFlex Duo Ablation Catheter to Treat Atrial Fibrillation

BD’s EnCor EnCompass System Secures the US FDA 510(k) Clearance for Breast Biopsy

Boston Scientific to Acquire Penumbra for ~$14.5B

Medtronic Reports 510(k) Clearance of MiniMed Go System for Diabetes Management

RefleXion Medical Reports the US FDA Clearance of RefleXion X2 Platform for Improved Tumor Detection

Saluda Medical Reports CE Mark Approval of EVA Sensing Technology for Personalized Pain Management

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