The US FDA Grants 510(k) clearance to Stryker’s OptaBlate BVN System for Vertebrogenic Pain

Shots: The US FDA has granted 510(k) clearance to the OptaBlate BVN system for minimally invasive procedure designed to deliver long-lasting relief from vertebrogenic pain OptaBlate BVN achieves ≥1cm lesions in 7min. & features a steerable curved introducer, with microinfusion tech to minimize impedance & charring, plus 10-gauge access tools for precision OptaBlate BVN combines…

ByRidhi RastogiMay 20, 2025

Weekly Snapshot

PharmaShots Weekly Snapshots (May 12, 2025 – May 16, 2025) 

PharmaShots Weekly Snapshots (May 12, 2025 – May 16, 2025)  This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A & Animal Health. Check out our full report below:     Johnson & Johnson Reveals P-III (ICONIC-TOTAL) Trial Data of Icotrokinra for Plaque Psoriasis Read More: J&J AstraZeneca Reports…

ByRidhi RastogiMay 16, 2025

News

Genesys Spine Unveils Stasys-C 3DP Cervical Standalone System to Streamline Anterior Cervical Procedures

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…

ByRidhi RastogiMay 15, 2025

News

Median Technologies Seeks the US FDA’s 510(k) Clearance of eyonis LCS for Lung Cancer Detection

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…

ByRidhi RastogiMay 14, 2025

News

Mentice Reports US Launch of Ankyras 4.0 to Advance Patient-Specific Aneurysm Planning for Neuro Interventions

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 &…

ByRidhi RastogiMay 13, 2025

News

QIAGEN to Acquire Genoox for ~$80M

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…

ByRidhi RastogiMay 13, 2025

News

Teal Health Reports the US FDA’s Approval of Teal Wand for Cervical Cancer Screening

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…

ByRidhi RastogiMay 12, 2025

Weekly Snapshot

PharmaShots Weekly Snapshots (May 05, 2025 – May 09, 2025)

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)…

ByRidhi RastogiMay 9, 2025

News

ALPCO Launches its Calprotectin Immunoturbidimetric Assay for Irritable Bowel Disease Diagnosis in the EU

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…

ByRidhi RastogiMay 9, 2025

News

Smith+Nephew Reports Trial Data of Cartiheal Agili-C to Treat Knee Cartilage Defects

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…

ByRidhi RastogiMay 8, 2025

The US FDA Grants 510(k) clearance to Stryker’s OptaBlate BVN System for Vertebrogenic Pain

PharmaShots Weekly Snapshots (May 12, 2025 – May 16, 2025)

Genesys Spine Unveils Stasys-C 3DP Cervical Standalone System to Streamline Anterior Cervical Procedures

Median Technologies Seeks the US FDA’s 510(k) Clearance of eyonis LCS for Lung Cancer Detection

Mentice Reports US Launch of Ankyras 4.0 to Advance Patient-Specific Aneurysm Planning for Neuro Interventions

QIAGEN to Acquire Genoox for ~$80M

Teal Health Reports the US FDA’s Approval of Teal Wand for Cervical Cancer Screening

PharmaShots Weekly Snapshots (May 05, 2025 – May 09, 2025)

ALPCO Launches its Calprotectin Immunoturbidimetric Assay for Irritable Bowel Disease Diagnosis in the EU

Smith+Nephew Reports Trial Data of Cartiheal Agili-C to Treat Knee Cartilage Defects

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