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Abbott
NEWS

Abbott’s TactiFlex Duo Ablation Catheter Secures FDA Approval for Atrial Fibrillation

Shots: The US FDA has approved TactiFlex Duo Ablation Catheter, Sensor Enabled to treat patients with challenging cases of atrial fibrillation (AFib) Approval was based on the results from Abbott's FlexPulse IDE study, with data recently presented at the ESC’26 & simultaneously published in EPEuropace, showing favorable safety & effectiveness outcomes in pts with paroxysmal AFib TactiFlex Duo delivers…
9 hours ago

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NEWS

Vara Gains CE Certification for Autonomous Breast Cancer Screening AI

Shots: Vara has secured CE certification under the EU Medical Device Regulation (Class IIb) for autonomous triage in organised breast cancer screening, enabling normal examinations to be reported without radiologist review ATMON (Autonomous-Triage Monitoring) is a real-time system that monitors AI performance, mammography hardware, system health, & site-level signals. If predefined limits are exceeded, the…
September 2, 2026

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NEWS

CorTec Receives Second FDA Breakthrough Device Designation for Brain Interchange system

Shots: The US FDA has granted Breakthrough Device Designation to Brain Interchange system for communication in people with non-progressive quadriplegia, letting users to control a computer cursor through thought alone The new designation builds on Brain Interchange’s April 2026 BDD for stroke motor rehabilitation. The same implant can function therapeutically by stimulating the brain to…
September 1, 2026

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NEWS

Natera and Angiex Partner to Monitor AGX101 Response Using Signatera

Shots: Natera has entered into collaboration with Angiex to use longitudinal Signatera testingfor circulating tumor DNA (ctDNA) to assess treatment response monitoring during AGX101 treatment AGX101 is designed to target TM4SF1-expressing tumor cells & tumor-associated endothelial cells, delivering a cytotoxic payload to both the tumor & its vasculature Angiex is conducting a P-I trial of…
August 28, 2026

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NEWS

HighLife Receives CE Mark Approval for Clarity Valve for Use with the HighLife TMVR System

Shots: HighLife received CE Mark approval for its HighLife Clarity Mitral Heart Valve for use with HighLife TMVR System for adults with symptomatic mod. to sev. or sev. mitral valve regurgitation (MR) who are unsuitable for surgery or transcatheter edge-to-edge repair Four-year follow-up of the first 35 consecutively treated pts showed durable valve performance, with…
August 28, 2026

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Roche
NEWS

Roche Reports FDA Approval of HER2 Companion Diagnostics for Gastroesophageal Cancer

Shots: The US FDA has granted approval to expand the use of Pathway HER2 (4B5) & Ventana HER2 Dual ISH tests to identify HER2+ metastatic gastroesophageal adenocarcinoma (GEA), incl. gastric, GEJ & esophageal adenocarcinoma The companion diagnostics can help identify pts who may be eligible for HER2-targeted treatment with two Ziihera (zanidatamab-hrii) regimens for 1L…
August 27, 2026

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Abbott
NEWS

Abbott Secures FDA Authorization for Libre Duo 10 Day, a Dual Glucose-Ketone Sensing Technology

Shots: FDA has approved Libre Duo 10 Day, a dual glucose-ketone sensing biowearable, to provide real-time glucose monitoring while continuously detecting rising ketones for diabetic ketoacidosis (DKA) emergency, with launch expected later this year Libre Duo 10 Day met FDA standards for both integrated continuous glucose monitoring (iCGM) & the new integrated continuous glucose &…
August 26, 2026

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NEWS

Tempus AI Secures FDA Clearance for AI-Enabled Pulmonary Hypertension ECG Tool

Shots: Tempus AI has received FDA 510(k) clearance for Tempus ECG-PH, an AI-enabled software device that analyzes standard 12-lead ECGs for signs associated with pulmonary hypertension (PH) Designed for patients aged 40 and older with cardiovascular symptoms but no known PH history, Tempus ECG-PH identifies ECG patterns associated with elevated mean pulmonary artery pressure Tempus…
August 25, 2026

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Roche
NEWS

Roche’ Elecsys pTau217 Test Receives the US FDA Clearance to Rule in or Rule Out Alzheimer’s-Related Amyloid Pathology

Shots: The US FDA has granted clearance to Elecsys pTau217 to measure the phosphorylated Tau (pTau) 217 protein to help rule in or rule out Alzheimer’s-related amyloid pathology in people (≥55yrs.) with signs or complaints of cognitive decline In adults aged 55+ with cognitive decline associated with Alzheimer’s disease, Elecsys pTau217 showed high agreement with…
August 24, 2026

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NEWS

Masimo Secures CE Mark for smartSedLine to Advance Anesthetic Management

Shots: Masimo has received CE Mark approval for smartSedLine, a brain function monitor featuring an AI-powered Patient State Index (PSi) algorithm designed to provide greater responsiveness to brain activity & improved stability during anesthesia smartSedLine continuously displays four real-time bilateral frontal EEG waveforms & key parameters, incl. the 0–100 PSi reflecting sedation level, supporting more…
August 19, 2026

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