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 Rastogi2 hours ago

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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 Dixit5 hours ago

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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 Rastogi3 days ago

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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

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Intelligent Bio Solutions and Syrma Johari MedTech Collaborate to Advance Global Production Capability and Margin Expansion

Shots: Intelligent Bio Solutions has entered into a strategic manufacturing partnership with Syrma Johari MedTech to scale production of its Intelligent Fingerprinting Drug Screening Reader and support long-term margin improvement Under the agreement, the partnership advances INBS’ global manufacturing strategy by diversifying suppliers, strengthening supply chain resilience, expanding capacity, and increasing flexibility ahead of anticipated multi-region…

ByDipanshu DixitJanuary 2, 2026

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KORU Medical Systems Seeks FDA Clearance for FreedomEDGE System to Deliver Phesgo in HER2+ Breast Cancer Patients

Shots: The US FDA has received the 510(k) premarket notification for FreedomEDGE infusion system to subcutaneously administer Phesgo (Perjeta/Herceptin/hyaluronidase-zzxf) in HER2+ breast cancer The Infusion System enables efficient large-volume SC drug delivery, addressing unmet needs in oncology infusion centers by improving nurse administration experience while supporting faster, more streamlined clinical workflows The system supports SC…

ByRidhi RastogiDecember 31, 2025

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StimLabs Reports the US FDA 510(k) Clearance of Theracor for Acute and Chronic Wound Management

Shots: The FDA has granted 510(k) clearance to Theracor, a human umbilical cord-derived medical device offered in sheet form, for wound care Indicated for the same wound types as StimLabs’ Corplex P, Theracor is used for partial & full-thickness wounds, pressure, venous, diabetic, & chronic vascular ulcers, tunneled/undermined wounds, surgical sites, trauma-related injuries, & draining…

ByRidhi RastogiDecember 30, 2025

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Bruno Vision Care Reports the US FDA Clearance of Deseyne for Presbyopia

Shots: FDA has cleared Deseyne, a daily disposable soft contact lens for presbyopia that uses patented Extended Depth of Focus technology Deseyne provides continuous near, intermediate, & distance vision through Cataltheia’s patented hyper-refractive central zone, showing a clinical advantage over multifocal lenses with minimal patient adaptation, strong comfort, & no adverse events reported in studies Made…

ByRidhi RastogiDecember 26, 2025

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Pulse Biosciences Receives the US FDA IDE Approval to Initiate Study for nsPFA System in Paroxysmal Atrial Fibrillation (PAF)

Shots: The US FDA has granted IDE approval to initiate the NANOPULSE-AF study of Pulse's nsPFA Cardiac Catheter System for the treatment of PAF The study will assess the primary safety and efficacy of the nsPFA Cardiac Catheter System in ~145 pts for the treatment of drug-resistant symptomatic PAF across 30 sites, incl. 3 outside…

ByRidhi RastogiDecember 19, 2025

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

Intelligent Bio Solutions and Syrma Johari MedTech Collaborate to Advance Global Production Capability and Margin Expansion

KORU Medical Systems Seeks FDA Clearance for FreedomEDGE System to Deliver Phesgo in HER2+ Breast Cancer Patients

StimLabs Reports the US FDA 510(k) Clearance of Theracor for Acute and Chronic Wound Management

Bruno Vision Care Reports the US FDA Clearance of Deseyne for Presbyopia

Pulse Biosciences Receives the US FDA IDE Approval to Initiate Study for nsPFA System in Paroxysmal Atrial Fibrillation (PAF)

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