Motif Neurotech Receives FDA IDE Approval to Initiate RESONATE Trial of Motif XCS System in Treatment-Resistant Depression

Shots: The US FDA has granted IDE approval to initiate RESONATE Early Feasibility Study of Motif XCS System in pts with treatment-resistant depression, who have received ≥2 medications The trial will assess 12mos. safety of Motif XCS System & procedure post-implantation & measure symptom reduction, quality of life, anxiety, & cognitive function using standard assessments…

ByRidhi RastogiApril 27, 2026

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FLEX Vascular Presents 12-month Real-World Data for FLEX Vessel Prep System at CX Symposium 2026

Shots: FLEX Vascular reported 12mos. results from the FLEX FIRST AV Registry at Charing Cross Symposium 2026, showing strong safety with 0% serious adverse events at 30 days & durable performance in hemodialysis access patients The study (n=130) demonstrated 40% primary patency in cephalic arch lesions & 100% secondary patency in AV grafts at 12mos.,…

ByRidhi RastogiApril 24, 2026

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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…

ByRidhi RastogiApril 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…

ByPrince GiriApril 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…

ByPrince GiriApril 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…

ByRidhi RastogiApril 15, 2026

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American Industrial Partners to Acquire Avanos Medical for ~$1.272B

Shots: Avanos Medical has entered into a definitive agreement to be acquired by affiliates of American Industrial Partners in an all-cash transaction valued at ~$1.272B enterprise value As per the deal, Avanos Medical shareholders will receive $25/share in cash, reflecting a ~72.1% premium to the Company's closing stock price on Apr 13, 2026; closing is…

ByRidhi RastogiApril 14, 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…

ByRidhi RastogiApril 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…

ByPrince GiriApril 13, 2026

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Waters Expands Cervical Cancer Screening Access with at-Home HPV Test Approval

Shots: The US FDA has granted clearance to the Onclarity HPV Self-Collection Kit & approved the BD Onclarity HPV Assay for at-home use, expanding access to cervical cancer screening The kit is tested with the BD Onclarity HPV Assay, detecting all high-risk HPV genotypes with individual & pooled results, & processed on the automated BD…

ByRidhi RastogiApril 9, 2026

Motif Neurotech Receives FDA IDE Approval to Initiate RESONATE Trial of Motif XCS System in Treatment-Resistant Depression

FLEX Vascular Presents 12-month Real-World Data for FLEX Vessel Prep System at CX Symposium 2026

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

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

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

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

American Industrial Partners to Acquire Avanos Medical for ~$1.272B

Protaryx Medical Secures FDA Clearance for its Transseptal Access Device

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

Waters Expands Cervical Cancer Screening Access with at-Home HPV Test Approval

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