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…
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…
Shots:
Minnesota Medical Technologies has reported the US FDA’s 510(k) clearance to StaySure for the management of fecal incontinence (FI)
A completed clinical trial demonstrated the device’s safety & efficacy, with a reduction in fecal incontinence frequency & improved QoL; full results are expected later in 2025
StaySure, marketed as Navina Insert in the EU, is…
Shots:
Roche has received the CE mark approval for its Elecsys pTau181 test to measure phosphorylated Tau 181 protein to help rule out Alzheimer’s-related amyloid pathology
Approval was backed by a global study of 787 pts (55–80yrs.) across the US, EU, & Australia, showing 93.8% negative predictive value (NPV) based on a 22.5% prevalence of…
Shots:
Medtronic has received CE mark to extend label of MiniMed 780G system to pts (≥2yrs.), pregnant women & T2D pts; application is under the FDA’s review for T2D, plus US trial for use in pts (2-6yrs.) is underway
Approval was backed by extensive clinical data incl. LENNY trial data in T1D pts (2–6 yrs), showing a…
This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, M&A, DigiHealth and Biosimilars. Check out our full report below:
Takeda Reports P-III (FirstLight & RadiantLight) Trials Data on Oveporexton for Narcolepsy Type 1 (NT1)
Read More: Takeda
AstraZeneca Reports P-III (BaxHTN) Trial Results of Baxdrostat for Uncontrolled or Treatment Resistant…
Shots:
Saluda Medical has reported full commercial launch of EVA in the US following its approval in Dec 2024
Saluda Medical will present new clinical data on EVA and the Evoke SmartLoop System at ASPN 2025, featuring 11 abstracts, one oral presentation, & over 37 total publications, incl. 36-month efficacy results from the EVOKE Study…
Shots:
Accuro 3S ultrasound system & SpineNav-AI received FDA clearance to provide anatomical guidance during needle or catheter placement; further regulatory filings for advanced features are planned, alongside ongoing clinical collaborations, limited release, & upcoming full market launch
Accuro 3S is a portable system featuring SpineNav-AI & a Dual-Array convex probe with 2 aligned transducer…
This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, M&A, and Biosimilars. Check out our full report below:
PulseSight Therapeutics Reports First Patient Dosing with PST-611 in P-I (PST-611-CT1) Trial for Dry AMD/Geographic Atrophy
Read More: PulseSight Therapeutics
BioAtla Presents Preliminary P-I Trial Data of BA3182 in Patients with…
Shots:
Dymicron received the US FDA’s IDE approval to initiate a pivotal trial of Triadyme-C, a cervical artificial disc, to treat symptomatic cervical disc disease (SCDD) across leading US spine centers starting Q4’25
The study will compare the safety and effectiveness of Triadyme-C vs. anterior cervical discectomy and fusion (ACDF). The 1EP of the study…

