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Utepreva Launches Utepreva Endometrial Sampler to Support Early Diagnosis of Endometrial Cancer

Shots: Utepreva has launched the Utepreva Endometrial Sampler, a single-use device designed to improve tissue capture & enable early diagnostic evaluation of endometrial cancer, with availability expected in Oct 2026 The device combines three mechanisms for single-pass sampling: a sponge tip absorbs tissue & fluid, a plunger-driven suction aspirates cells & prevents loss, & the…
April 23, 2026

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Pulnovo Raises $100M Led by Medtronic to Advance PADN System for Pulmonary Hypertension

Shots: Pulnovo Medical secured an oversubscribed $100M financing round led by Medtronic, with existing participation from EQT, Qiming Venture Partners, Gaorong Ventures, OrbiMed, and Lilly Asia Ventures The Pulnovo Medical and Medtronic also entered a strategic commercial agreement to explore future global commercialization opportunities leveraging the commercial synergy between Pulnovo and Medtronic, along with Medtronic’s distinctive and…
April 20, 2026

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Philips Receives US FDA 510(k) Clearance for AI-Powered Spectral CT Verida System

Shots: The US FDA has granted 510(k) clearance to Philips for its Spectral CT Verida system, an AI-powered detector-based spectral CT platform for diagnostic imaging Verida integrates always-on spectral imaging with AI-based deep learning reconstruction to enhance image quality, reduce noise, and improve diagnostic precision across radiology, cardiology, and oncology applications The system enables simultaneous…
April 17, 2026

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TOBY Secures US FDA Breakthrough Device Designation for Urine-Based Multi-Cancer Test

Shots: The US FDA has granted Breakthrough Device Designation to the urine-based Multi-Cancer Early Detection (MCED) test  The non-invasive platform analyzes volatile organic compounds (VOCs) using spectroscopy & machine learning to detect multiple cancers from a single urine sample The test provides an alternative to blood-based screening, supporting scalable population screening, while the designation enables…
April 15, 2026

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Protaryx Medical Secures FDA Clearance for its Transseptal Access Device

Shots: The US FDA has granted 510(k) clearance to the Transseptal Puncture Device to advance minimally invasive access for left-heart procedures, with plans to begin US commercialization  The Device is a next-gen system enabling zero-exchange access to the left heart, integrating RF guidewire tech with standard electrosurgical generators & an echogenic, extendable atraumatic probe to…
April 14, 2026

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Miracell Reports US FDA 510(k) Clearance for SMART M-CELL PRP and Bone Marrow Concentration Systems

Shots: The US FDA has granted 510(k) clearance to Miracell’s SMART M-CELL PRP Concentration System and Bone Marrow Concentration System, including associated blood and bone marrow kits Clearance was based on substantial equivalence to SmartPReP, with the system demonstrating high cell viability, efficient growth factor extraction, and integrated performance across centrifuge and kit components SMART…
April 13, 2026

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Anumana Secures the US FDA 510(k) Clearance for its ECG-AI Algorithm to Detect Risk of Cardiac Amyloidosis Early

Shots: The US FDA has granted clearance to ECG-AI algorithm, a software-as-a-medical-device designed for cardiac amyloidosis (CA), cleared for use with standard 12-lead ECGs ECG-AI algorithm analyzes ECG waveforms to detect CA-related patterns not visible to clinicians, integrating into existing workflows using routine ECGs without additional testing to help identify at-risk pts & guide next…
April 9, 2026

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