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 Rastogi3 days ago

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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…

ByRidhi Rastogi3 days ago

NEWS

Endospan’s Nexus System Receives the US FDA Approval to Treat Aortic Arch Disease

Shots: The US FDA has approved the Nexus Aortic Arch Stent Graft for the treatment of aortic arch disease Approval was supported by the 1yr. results from the TRIOMPHE IDE trial assessing Nexus in aortic arch disease, incl. chronic aortic dissections, in pts at high risk for open surgical repair, which showed safe & effective treatment in…

ByRidhi Rastogi4 days ago

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Organogenesis Reports Trial Results on PuraPly AM for Wound Healing in Diabetic Foot Ulcers

Shots: Organogenesis has reported the trial completion of PuraPly AM, assessing it in combination with SoC vs SOC alone for the management of non-healing diabetic foot ulcers (DFUs) The 170-patient trial achieved its 1EP, showing significant wound closure at 12wks., with the company planning to publish the study results soon in a journal PuraPly AM…

ByRidhi Rastogi5 days ago

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Allevion Secures FDA Clearance for Vantage Spinal Decompression System

Shots: The US FDA has granted 510K Clearance to Vantage, a fully disposable, sterile system designed for minimally invasive lumbar decompression procedures Vantage features a structured “locate, dilate, decompress” workflow with integrated illumination for direct visualization, enabling precise, depth-controlled bone resection while improving procedural consistency & safety The single-use system eliminates the need for reusable…

ByRidhi RastogiApril 6, 2026

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restor3d Reports Full Commercial Launch of Aeros Modular Stem System for Total Ankle Replacement

Shots: restor3d has reported the full commercial availability of the Aeros Modular Stem System, a next-generation total ankle replacement platform designed to enhance implant stability, preserve bone, & improve surgical efficiency Launched with a limited market release, the system enables flexible implant configurations and introduces a modular stem tibial implant that can be placed via…

ByRidhi RastogiApril 3, 2026

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Zeto Receives US FDA 510(k) Clearance for Zeto New Wave to Advance Outpatient EEG

Shots: The US FDA has granted 510(k) clearance to Zeto New Wave to perform EEG efficiently in outpatient clinics & homes Zeto New Wave is an easy-to-use outpatient EEG system with 21 soft-tip electrodes (10–20 system), offering full head coverage & paired with a compact device capturing synchronized video/audio Designed for short-term recordings up to 2.5hrs., the…

ByRidhi RastogiApril 3, 2026

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JenaValve Launches Trilogy Transcatheter Heart Valve System in the US to Treat Symptomatic, Severe Aortic Regurgitation (ssAR)

Shots: JenaValve Technology has launched Trilogy THV System to treat ssAR in pts at high or greater surgical risk & reported successful first cases across the US The System uses radiopaque locators to attach directly to native aortic leaflets without calcification, allowing stable implantation, precise alignment, reduced paravalvular regurgitation, & preserving future coronary access with…

ByRidhi RastogiApril 2, 2026

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Elidah Reports US FDA Clearance of Elitone for Men to Treat Post-Prostatectomy Urinary Incontinence

Shots: The US FDA has granted clearance to Elitone for Men to help restore bladder control after prostate surgery, with US availability expected in Apr 2026 Elitone for Men is a non-invasive, at-home therapy that delivers neuromuscular stimulation to strengthen pelvic floor muscles, improving bladder control, with a simple 20min. daily use enabling consistent treatment…

ByRidhi RastogiApril 1, 2026

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Anumana Secures the US FDA 510(k) Clearance for its ECG-AI Algorithm to Detect Pulmonary Hypertension Early

Shots: The FDA has granted 510(k) clearance to an AI-enabled PH algorithm, a software-as-a-medical-device designed to detect early signs of PH, cleared for use with standard 12-lead ECGs The PH algorithm detects subtle early PH patterns in standard 12-lead ECGs & integrates with EHR & ECG management systems, plus it operates entirely within the health…

ByRidhi RastogiMarch 30, 2026

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

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

Endospan’s Nexus System Receives the US FDA Approval to Treat Aortic Arch Disease

Organogenesis Reports Trial Results on PuraPly AM for Wound Healing in Diabetic Foot Ulcers

Allevion Secures FDA Clearance for Vantage Spinal Decompression System

restor3d Reports Full Commercial Launch of Aeros Modular Stem System for Total Ankle Replacement

Zeto Receives US FDA 510(k) Clearance for Zeto New Wave to Advance Outpatient EEG

JenaValve Launches Trilogy Transcatheter Heart Valve System in the US to Treat Symptomatic, Severe Aortic Regurgitation (ssAR)

Elidah Reports US FDA Clearance of Elitone for Men to Treat Post-Prostatectomy Urinary Incontinence

Anumana Secures the US FDA 510(k) Clearance for its ECG-AI Algorithm to Detect Pulmonary Hypertension Early

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