Shots:
Miach Orthopaedics has completed enrollment in the BEAR MOON study of BEAR Implant for the treatment of anterior cruciate ligament (ACL) tears
BEAR MOON trial, led by Cleveland Clinic, enrolled 150 pts (18–55yrs.) with complete ACL tears, randomized to receive either the BEAR Implant or autograft bone-patellar tendon-bone ACL reconstruction, with outcomes assessed at 6mos.,…
Shots:
The US FDA has approved label expansion of Farapulse PFA System to incl. treatment of drug-refractory, symptomatic persistent atrial fibrillation (AF)
Approval was backed by P-I data from the ADVANTAGE AF trial, which met safety & effectiveness endpoints in 260 pts intolerant to at least Class I/III anti-arrhythmic drug across 43 global sites; data…
Shots:
Seegene has launched the STAgora platform for infectious disease analysis, with a formal launch planned at ADLM 2025to seek business partnerships & highlight STAgora's integration with Cureca PCR system
STAgora, when integrated with Seegene’s syndromic quantitative PCR tech, provides advanced visibility into single & multi-pathogen infections to allow clinicians to make faster, more informed…
This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, and Biosimilar. Check out our full report below:
Neurocrine Reports Data From KINECT-HD Study Evaluating INGREZZA in Huntington’s Disease (HD)
Read More: Neurocrine
UCB Reports the P-III Data of Fenfluramine in CDKL5 Deficiency Disorder (CDD) Patients
Read More: UCB …
Shots:
MatOrtho has reported the European CE Mark approval of ReCerf for hip resurfacing arthroplasty, allowing wider availability in UK, EU & markets accepting CE mark approval
ReCerf was previously approved by Australia’s TGA in Nov 2024 & was used in over 1,600 pts since 2018, with highly positive patient-reported outcomes & a low 6yr. revision…
Shots:
The US FDA has granted 510(k) clearance to Felix NeuroAI Wristband for the treatment of essential tremor in the upper limbs of the adults; available in select US states in 2025, with nationwide availability anticipated in 2026
Clearance was supported by TRANQUIL study assessing Felix wristband vs sham device, which showed reduced tremors & improved…
This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilar, and Animal Health. Check out our full report below:
Teva Reports the Data from the P-IV (PEARL) Study of Ajovy (fremanezumab) for Chronic and Episodic Migraine Prevention
Read More: Teva
Merck Reports the Data from P-III (HYPERION)…
Shots:
Nitinotes has received the FDA’s IDE approval to begin a pivotal trial of its EndoZip System for endoscopic sleeve gastroplasty; enrollment is set to start by Q3’25
The trial will assess the safety & efficacy of the EndoZip System for obesity pts. (n=184) across up to 10 US and additional international sites. As a…
This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilar, Animal Health & DigiHealth. Check out our full report below:
Johnson & Johnson Reports P-II (RedirecTT-1) Trial Data on Talvey + Tecvayli for R/R Multiple Myeloma
Read More: J&J
Camurus Reports Topline P-IIb (POSITANO) Trial Data on CAM2029 for…
Shots:
J&J MedTech has launched Variable Angle Optimized Locking Technology (VOLT) Distal Radius (Wrist) & VOLT Proximal Humerus 3.5 Plating System in the US
VOLT Wrist, developed with the AO Technical Commission, features the VOLT Two-Column Distal Radius Rim Plate with a new shape that sits more distal to target fragments & is less prominent…

