Shots:
Genesys Spine has launched its Stasys-C 3DP Cervical Standalone System to simplify anterior cervical procedures
Stasys-C has a non-screw-based fixation method with quick, non-impacting anchor deployment via a direct anterior approach, plus it has Quick Turn Cam Lock, which allows visual anchor engagement & locking confirmation, while the SemaFour surface design maximizes wettability, surface…
Shots:
The US FDA has received application for 510(k) clearance of eyonis Lung Cancer Screening (LCS) to detect & diagnose lung cancer, with clearance expected in Q3'25
Submission is backed by 2 studies, REALITY & RELIVE, both of which met their 1EP; REALITY depicted an AUC of 0.904 (vs 0.80 threshold), accurately detecting early lung…
Shots:
Following FDA 510(k) clearance, Mentice has launched Ankyras 4.0 for pts-specific flow diverter planning to treat intracranial aneurysms in the US
Ankyras 4.0 introduces DICOM node integration, a redesigned user interface & broader accessibility via online platform & mobile apps, plus its integration with VIST simulation allows virtual case rehearsal to accelerate decision-making &…
Shots:
QIAGEN has entered into a definitive agreement to acquire Genoox, a provider of AI-driven software that allows clinical laboratories to scale & accelerate the analysis of complex genetic tests
As per the deal, Genoox will receive $70M in cash & up to $10M in additional milestone payments
Acquisition adds Franklin, Genoox’s cloud-based platform, to…
Shots:
The US FDA has approved Teal Wand to screen cervical cancer at-home for women (25-65yrs.); commercially available in California by Jun 2025, with further expansion worldwide
Approval was based on SELF-CERV study, which showed Teal Wand detected cervical precancer 96% of the time, with 94% participants preferring at-home screening test if it was as…
This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, Biosimilar & Animal Health. Check out our full report below:
Recursion Presents Preliminary P-Ib/II (TUPELO) Trial Data of REC-4881 for Familial Adenomatous Polyposis (FAP) at DDW 2025
Read More: Recursion
Chengdu Origen and Vanotech Report the First Patient Dosing in P-I (VAN-2401)…
Shots:
ALPCO has launched its Calprotectin Immunoturbidimetric Assay for the diagnosis of IBD, incl. Crohn's disease & ulcerative colitis in the EU
ALPCO has also enrolled 1st pts in its pivotal trial for FDA clearance of its automated chemiluminescent calprotectin assay on the KleeYa system, following completion of the FDA pre-submission in Mar 2025, with…
Shots:
Smith+Nephew has reported data from its trial assessing Cartiheal Agili-C implant vs SoC for the treatment of knee cartilage defects
Trial showed that the Cartiheal Agili-C significantly improved knee pain & quality of life over 4yrs., with an 87% reduced risk of total knee arthroplasty or osteotomy compared to SoC
Pts also reported improved…
Shots:
Roche has launched its Elecsys PRO-C3 test, developed with Nordic Bioscience to evaluate the severity of liver fibrosis in pts showing signs of metabolic dysfunction–associated steatotic liver disease
Elecsys PRO-C3 test requires a single assay & in combination with ADAPT formula (incl. PRO-C3 levels, platelet count, age, & diabetes status) provides clear assessment of…
Shots:
Endogenex has reported REGENT-1 Australian study data of ReCET System for the treatment of inflamed & dysfunctional tissue associated with type 2 diabetic (T2D) duodenopathy; REGENT-1 is also being conducted in the US
The study showed dose-responsive improvements in insulin sensitivity & beta cell function at 12wks., sustained through 48wks., with 100% procedural success…

