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U.S. FDA clears first stapler designed for single-port robotic surgeryU.S. FDA clears first stapler designed for single-port robotic surgery

U.S. FDA clears first stapler designed for single-port robotic surgery

Intuitive’s SureForm 45 stapler available for thoracic, colorectal, and urology procedures April 10, 2025 09:15 ET  | Source: Intuitive Surgical,…

6 days ago
DOSIsoft PLANET Onco Dose receives CE MDR Mark and new FDA 510(k) clearanceDOSIsoft PLANET Onco Dose receives CE MDR Mark and new FDA 510(k) clearance

DOSIsoft PLANET Onco Dose receives CE MDR Mark and new FDA 510(k) clearance

PARIS, April 7, 2025 /PRNewswire/ -- DOSIsoft, leading provider of patient-specific imaging and dosimetry software solutions for radiation oncology and nuclear…

1 week ago
FDA Watch: The Quiet Gold Rush in AI-Powered Medical DevicesFDA Watch: The Quiet Gold Rush in AI-Powered Medical Devices

FDA Watch: The Quiet Gold Rush in AI-Powered Medical Devices

Equity Insider News Commentary Issued on behalf of Avant Technologies Inc. VANCOUVER, BC, April 2, 2025 /PRNewswire/ -- Equity Insider News Commentary – Artificial…

2 weeks ago
FDA approves Novartis radioligand therapy Pluvicto for earlier use before chemotherapy in PSMA-positive metastatic castration-resistant prostate cancerFDA approves Novartis radioligand therapy Pluvicto for earlier use before chemotherapy in PSMA-positive metastatic castration-resistant prostate cancer

FDA approves Novartis radioligand therapy Pluvicto for earlier use before chemotherapy in PSMA-positive metastatic castration-resistant prostate cancer

Ad hoc announcement pursuant to Art. 53 LR New indication approximately triples eligible patient population, allowing Pluvicto® to be used…

3 weeks ago
Pleco Therapeutics Announces Positive Outcome of Pre-IND meeting with FDA for PTX-252 in Acute Myeloid LeukaemiaPleco Therapeutics Announces Positive Outcome of Pre-IND meeting with FDA for PTX-252 in Acute Myeloid Leukaemia

Pleco Therapeutics Announces Positive Outcome of Pre-IND meeting with FDA for PTX-252 in Acute Myeloid Leukaemia

NIJMEGEN, The Netherlands, March 26, 2025 (GLOBE NEWSWIRE) -- Pleco Therapeutics, a clinical-stage biopharmaceutical company developing novel therapies for difficult-to-treat…

3 weeks ago
FDA Issues Nyxoah an Approvable Letter for its Genio SystemFDA Issues Nyxoah an Approvable Letter for its Genio System

FDA Issues Nyxoah an Approvable Letter for its Genio System

INSIDE INFORMATIONREGULATED INFORMATION FDA Issues Nyxoah an Approvable Letter for its Genio® System Mont-Saint-Guibert, Belgium – March 26, 2025, 8:00am…

3 weeks ago
Press Release: Chlamydia vaccine candidate granted fast track designation by the US FDAPress Release: Chlamydia vaccine candidate granted fast track designation by the US FDA

Press Release: Chlamydia vaccine candidate granted fast track designation by the US FDA

Chlamydia vaccine candidate granted fast track designation by the US FDA Chlamydia infection can contribute to pelvic inflammatory diseases in…

3 weeks ago
Novartis receives third FDA approval for oral Fabhalta (iptacopan) the first and only treatment approved in C3 glomerulopathy (C3G)Novartis receives third FDA approval for oral Fabhalta (iptacopan) the first and only treatment approved in C3 glomerulopathy (C3G)

Novartis receives third FDA approval for oral Fabhalta (iptacopan) the first and only treatment approved in C3 glomerulopathy (C3G)

Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first and only treatment approved in C3 glomerulopathy (C3G)…

4 weeks ago
Bavarian Nordic Receives U.S. FDA Approval of Chikungunya Vaccine for Persons Aged 12 and OlderBavarian Nordic Receives U.S. FDA Approval of Chikungunya Vaccine for Persons Aged 12 and Older

Bavarian Nordic Receives U.S. FDA Approval of Chikungunya Vaccine for Persons Aged 12 and Older

First chikungunya vaccine approved for persons as young as 12 years old, addressing an unmet need for chikungunya prevention for…

2 months ago
UPDATE: SpringWorks Therapeutics Announces FDA Approval of GOMEKLI (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PNUPDATE: SpringWorks Therapeutics Announces FDA Approval of GOMEKLI (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN

UPDATE: SpringWorks Therapeutics Announces FDA Approval of GOMEKLI (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN

– GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN – – Approval based on…

2 months ago
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