Amber Implants Reports Trial Data of VCFix Spinal System for Treating Vertebral Compression Fractures

Shots: Amber Implants has reported 1yr. follow-up data from its trial assessing VCFix Spinal System in Germany for the treatment of vertebral compression fractures Trial showed immediate & sustained improvements in pain, with ≥8-point decrease in NPRS along with 84-point reduction in disability scores (per ODI) at 6mos., which were sustained through 1yr. in pts with…

ByRidhi RastogiJune 4, 2025

Weekly Snapshot

PharmaShots Weekly Snapshots (May 26, 2025 – May 30, 2025) 

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A & Biosimilar. Check out our full report below:  Gilead Reports Topline P-III (ASCENT-03) Trial Data of Trodelvy for Triple-Negative Breast Cancer (TNBC) Read More: Gilead Genentech Reports P-III (STARGLO) Trial Data on Columvi for R/R Diffuse Large B-Cell Lymphoma…

ByRidhi RastogiMay 30, 2025

News

CoreMap Reports the US FDA’s IDE Approval for CoreMap’s EP Map-Guided AF Ablation Study

Shots: CoreMap received the US FDA’s IDE approval of CoreMap EP (Endocardial Electrophysiology) to extend the 3-phase INvENI clinical study into the US in pts with Atrial Fibrillation (AF) and long-standing persistent AF The P-I study assessed acute safety of CoreMap EP in 14 pts while P-II study showed acute safety & effectiveness in 15 pts. The…

ByRidhi RastogiMay 30, 2025

News

Reflow Medical’s Spur Peripheral Retrievable Stent System Receives the US FDA’s De Novo Clearance for BTK-CLTI Treatment

Shots: FDA has granted De Novo clearance to the Spur Stent System for treating de novo or restenotic lesions post-predilatation in pts with infrapopliteal arterial disease In recently concluded DEEPER REVEAL trial (n=130), the system achieved 99.2% technical success rate & 97% freedom from MALE & POD at 30 days post-predilatation for below-the-knee (BTK) treatment…

ByRidhi RastogiMay 30, 2025

News

AnX Robotica’s MotiliCap and MotiliScan Receive the US FDA’s 510(k) Clearance for GI Motility Monitoring

Shots: The US FDA has granted 510(k) clearance to MotiliCap & MotiliScan for GI motility monitoring MotiliCap is a radiation & sedation-free motility capsule that evaluates gastrointestinal transit across stomach, small bowel, & colon, with detailed GI data exported directly to MotiliScan for analysis MotiliScan is a companion software that offers intuitive visualization, data analysis,…

ByRidhi RastogiMay 28, 2025

News

AI Medical Technology’s Dermalyser Receives European CE Mark Approval for Melanoma Detection

Shots: AI Medical Technology has reported the CE mark approval of Dermalyser for melanoma detection; commercialization to begin in 2025 Dermalyser was validated in AI-DSMM study across 36 Swedish centers, where it analyzed 253 suspicious lesions in 228 pts, identifying 21 melanomas (11 as thin invasive & 10 as in situ). It also achieved AUROC…

ByRidhi RastogiMay 27, 2025

Weekly Snapshot

PharmaShots Weekly Snapshots (May 19, 2025 – May 23, 2025)  

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilar, DigiHealth & Animal Health. Check out our full report below:   Apnimed Reports Topline P-III (SynAIRgy) Trial Data of AD109 for Obstructive Sleep Apnea (OSA) Read More: Apnimed Ionis Reveals Topline P-III (ESSENCE) Trial Data of Olezarsen for Moderate…

ByRidhi RastogiMay 23, 2025

TOP 20

Top 20 Medical Device Companies of 2025

Shots: Driven by continuous innovation, the MedTech sector is evolving rapidly to enhance preventive, diagnostic, and therapeutic capabilities in healthcare In 2023, the global MedTech market was valued at $668.2B and is projected to reach $989.1B by 2033, growing at a CAGR of approximately 4%. Medtronic led the industry with a revenue of $33.12B, followed…

ByPrince GiriMay 22, 2025

News

ReGelTec’s HYDRAFIL System Gains European CE Mark Approval for Chronic Low Back Pain

Shots: ReGelTec has received European MDR CE Mark approval for its Class III HYDRAFIL System, a disc augmentation therapy designed to reduce pain, improve daily function & eliminate the need for invasive surgeries Approval was based on a study of 75 pts showing over 80% improvement in Oswestry Disability Index (ODI) scores & >70% pain…

ByRidhi RastogiMay 22, 2025

News

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

Amber Implants Reports Trial Data of VCFix Spinal System for Treating Vertebral Compression Fractures

PharmaShots Weekly Snapshots (May 26, 2025 – May 30, 2025)

CoreMap Reports the US FDA’s IDE Approval for CoreMap’s EP Map-Guided AF Ablation Study

Reflow Medical’s Spur Peripheral Retrievable Stent System Receives the US FDA’s De Novo Clearance for BTK-CLTI Treatment

AnX Robotica’s MotiliCap and MotiliScan Receive the US FDA’s 510(k) Clearance for GI Motility Monitoring

AI Medical Technology’s Dermalyser Receives European CE Mark Approval for Melanoma Detection

PharmaShots Weekly Snapshots (May 19, 2025 – May 23, 2025)

Top 20 Medical Device Companies of 2025

ReGelTec’s HYDRAFIL System Gains European CE Mark Approval for Chronic Low Back Pain

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

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