Nyxoah Receives the US FDA Approval for Genio System to Treat Obstructive Sleep Apnea

Shots: The US FDA has approved Genio system for pts with mod. to sev. obstructive sleep apnea (15 ≤ Apnea-Hypopnea Index ≤ 65); US commercialization is officially initiated Approval was based on the DREAM trial, which met its 1 & 2EPs, showing a 63.5% AHI responder rate, 71.3% oxygen desaturation index responder rate, & 70.8% median AHI…

ByRidhi RastogiAugust 11, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Aug 04, 2025 – Aug 08, 2025) 

This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, Biotech, M&A and Biosimilars. Check out our full report below:  Roche Reports P-III (Portal) Trial Data on Susvimo for Neovascular Age-Related Macular Degeneration (nAMD) Read More: Roche Ethris Reports First Patient Dosing in P-IIa Trial of ETH47 for Asthma Read…

ByRidhi RastogiAugust 8, 2025

NEWS

Roche Receives the US FDA’s 510(k) Clearance for cobas Respiratory 4-flex for Comprehensive Respiratory Pathogen Detection

Shots: The US FDA has granted 510(k) clearance to cobas Respiratory 4-flex, which utilizes TAGS technology for simplification of respiratory testing & improving diagnostic speed as well as accuracy The cobas Respiratory 4-flex integrates seamlessly with cobas 5800, 6800 & 8800 systems to allow qualitative detection & differentiation of SARS-CoV-2, influenza A/B, as well as…

ByDipanshu DixitAugust 7, 2025

NEWS

AliveDx Receives the CE Mark Approval for MosaiQ AiPlex VAS Assay to Diagnose Autoimmune Vasculitis

Shots: AliveDx has received the European IVDR-CE mark approval for MosaiQ AiPlex Vasculitis (VAS) assay to improve & accelerate diagnosis of Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitides & Anti-GBM (Goodpasture's) disease VAS assay diagnoses autoimmune vasculitis using just 10μL of sample in a single test, with 3 key autoantibody markers: MPO, PR3, & GBM VAS assay allows accurate serological evaluation with…

ByRidhi RastogiAugust 5, 2025

NEWS

Materna Medical Reports Enrolment Completion in EASE Trial of Ellora System to Reduce Pelvic Injury from Vaginal Delivery

Shots: Materna Medical has completed enrolment in its EASE trial of Ellora Obstetrical System (formerly Materna Prep device) for first-time mothers Trial will evaluate safety & effectiveness of the Ellora System vs SoC in 420 first-time mothers for the reduction of pelvic muscle injury during vaginal delivery; EASE trial will support the upcoming US FDA’s…

ByRidhi RastogiAugust 4, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Jul 28, 2025 – Aug 01, 2025) 

This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, Animal Health and Biosimilars. Check out our full report below: Memo Therapeutics Reports P-II (SAFE KIDNEY II) Trial Data on Potravitug to Treat BKPyV Infection in Kidney Transplant Recipients Read More: Memo therapeutics Eli Lilly Reports Topline P-III (BRUIN…

ByRidhi RastogiAugust 1, 2025

NEWS

Bioventus’ TalisMann and StimTrial Secure the US FDA 510(k) Clearances for Chronic Pain Management

Shots: The US FDA has granted 510(k) to both TalisMann & StimTrial for the management of chronic pain; limited US launch is planned in Q3’25, with broader rollout expected in early 2026 TalisMann integrates patented electric field conduction with a pulse generator to target deeper, larger nerves, & deliver long-term relief from chronic nerve pain,…

ByRidhi RastogiAugust 1, 2025

NEWS

SetPoint Medical Receives the US FDA’s Approval for its SetPoint System to Treat Rheumatoid Arthritis

Shots: The US FDA has approved the SetPoint System to treat adults with mod. to sev. rheumatoid arthritis (RA) who are inadequately managed by or intolerant to existing advanced therapies, incl. biologics & targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs) Approval was based on RESET-RA study evaluating SetPoint System vs sham device in 242 pts, which…

ByRidhi RastogiJuly 31, 2025

NEWS

Cardiosense’s CardioTag Device Receives the US FDA’s 510(k) Clearance for Cardiac Function Assessment

Shots: The US FDA has granted 510(k) clearance to CardioTag device for assessing cardiac function Upon regulatory approval for the PCWP Analysis Software, the algorithm will be integrated with the CardioTag device for advanced heart failure management, following a multicenter study showing its PCWP value estimates matched implantable hemodynamic sensor accuracy in HFrEF pts; data was published…

ByRidhi RastogiJuly 31, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Jul 21, 2025 – Jul 25, 2025)  

This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, M&A, DigiHealth, Animal Health and Biosimilars. Check out our full report below: AstraZeneca Reports P-III (FLAURA2) Trial Findings on Tagrisso Regimen to Treat EGFRm NSCLC Read More: AstraZeneca Sun Pharma Reports Topline Data from P-III (INSPIRE-1 & INSPIRE-2) Trials of…

ByRidhi RastogiJuly 25, 2025

Nyxoah Receives the US FDA Approval for Genio System to Treat Obstructive Sleep Apnea

PharmaShots Weekly Snapshots (Aug 04, 2025 – Aug 08, 2025)

Roche Receives the US FDA’s 510(k) Clearance for cobas Respiratory 4-flex for Comprehensive Respiratory Pathogen Detection

AliveDx Receives the CE Mark Approval for MosaiQ AiPlex VAS Assay to Diagnose Autoimmune Vasculitis

Materna Medical Reports Enrolment Completion in EASE Trial of Ellora System to Reduce Pelvic Injury from Vaginal Delivery

PharmaShots Weekly Snapshots (Jul 28, 2025 – Aug 01, 2025)

Bioventus’ TalisMann and StimTrial Secure the US FDA 510(k) Clearances for Chronic Pain Management

SetPoint Medical Receives the US FDA’s Approval for its SetPoint System to Treat Rheumatoid Arthritis

Cardiosense’s CardioTag Device Receives the US FDA’s 510(k) Clearance for Cardiac Function Assessment

PharmaShots Weekly Snapshots (Jul 21, 2025 – Jul 25, 2025)

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