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Neuspera Medical’s Integrated Sacral Neuromodulation System Secures the US FDA Approval for Urinary Urge Incontinence

Shots: The US FDA has approved integrated sacral neuromodulation (iSNM) system to treat urinary urge incontinence (UUI) iSNM device was evaluated in a P-II trial in 128 pts, which showed 84.2% pts achieved ≥50% reduction in urgent leaks, with 84% & 42% responders experiencing >75% & 100% reduction, respectively in UUI symptoms at 6mos.; 3.5x…
11 hours ago

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Brain Navi Biotechnology Reports the US FDA’s 510(k) Clearance of NaoTrac for Neurosurgical Procedures

Shots: Brain Navi Biotechnology has received the US FDA’s 510(k) clearance for NaoTrac neurosurgical robot NaoTrac is a stereotaxic guiding surgical device that uses SMART tech for rapid, non-contact, frameless registration by aligning the pts anatomy with preoperative imaging, & a robotic arm to guide instruments while keeping the surgeon in control NaoTrac integrates AI…
1 day ago

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Inquis Medical Reports the US FDA’s 510(k) Clearance of AVENTUS Thrombectomy System to Treat Pulmonary Embolism

Shots: The US FDA has granted 510(k) clearance to the AVENTUS Thrombectomy System for the treatment of pulmonary embolism (PE), expanding its prior clearance for use in the peripheral vasculature AVENTUS was evaluated in a completed pivotal IDE trial for aspiration thrombectomy with filtered blood reinfusion in intermediate-risk PE pts, which showed rapid improvement in…
2 days ago

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Weekly Snapshot

PharmaShots Weekly Snapshots (Jun 09, 2025 – Jun 13, 2025)  

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilar & Animal Health. Check out our full report below:   Apellis Pharmaceuticals and Sobi Report P-III (VALIANT) Trial Data of Empaveli for C3 Glomerulopathy (C3G) and Primary IC-MPGN  Read More: Apellis Pharmaceuticals and Sobi  Daiichi Sankyo Reports First Patient…
June 13, 2025

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NeurentMedical
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Neurent Medical Receives the US FDA’s 510(k) Clearance of NEUROMARK System for Chronic Rhinitis

Shots: The US FDA has granted 510(k) clearance to the next generation NEUROMARK system for pts with chronic rhinitis The new system optimizes posterior nasal nerve treatment by providing real-time feedback for accurate electrode placement & confirming treatment delivery, with a flexible shaft & atraumatic leaflets that conform to pts anatomy for maximizing treatment coverage…
June 12, 2025

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TYBR Health’s B3 GEL System Receives the US FDA’s 510(k) Clearance to Protect Healing Tissue and Preserve Function

Shots: The US FDA has granted 510(k) clearance to the B3 GEL System to protect healing tissue planes and preserve mobility; launch is anticipated at the end of 2025 Preclinical studies supporting clearance showed that B3 GEL reduced tissue binding and improved range of motion, with greater flexion and extension in treated models compared to controls…
June 10, 2025

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LEX Diagnostics
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LEX Diagnostics Seeks 510(k) Clearance and CLIA Waiver Status for its VELO system to Deliver Highly Sensitive PCR Results

Shots: The US FDA has received 510(k) clearance & CLIA waiver application of VELO system for highly sensitive PCR results for respiratory pathogens LEX Diagnostics has completed US trials of the VELO system & Influenza/COVID assay during the 2024/2025 season & expects 510(k) clearance by late 2025 or early 2026, pending FDA review VELO system…
June 9, 2025

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News

Tracer Biotechnologies Collaborates with QIAGEN to Co-Develop and Commercialize Tracer dPCR & Tracer WGS for Solid Tumors

Shots: Tracer has entered into a strategic collaboration with QIAGEN to co-develop & commercialize Tracer dPCR & Tracer WGS MRD assays for solid tumors on QIAGEN’s QIAcuity digital PCR platform Collaboration aims to provide highly sensitive, cost-effective, & decentralized MRD testing using QIAcuity’s PCR platform, allowing oncologists to monitor cancer recurrence & guide personalized treatment…
June 6, 2025

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Avicenna.AI Receives European CE Mark Approval for its CINA-VCF Quantix and CINA-CSpine

Shots: Avicenna.AI has received the European CE Mark approval for its AI-powered tools, CINA-VCF Quantix & CINA-CSpine to detect & assess unsuspected vertebral compression fractures (VCFs) & cervical spine fractures, respectively in pts undergoing CT scans CINA-VCF Quantix analyzes chest &/or abdomen CTs in pts (≥50yrs.), where it automatically labels vertebrae as well as calculates…
June 6, 2025

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TelaBio
News

TELA Bio Launches OviTex Inguinal for Robotic and Laparoscopic Inguinal Hernia Repair in the EU

Shots: TELA Bio has launched OviTex Inguinal in the EU for laparoscopic & robotic-assisted inguinal hernia repair; OviTex Inguinal to be showcased at EHS 2025 OviTex Inguinal is available in 2 trocar-compatible configurations, consisting of 3 or 4 layer anatomically shaped devices that provide surgeons with flexible options designed to meet pts, technique, or procedure-specific needs…
June 4, 2025

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