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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…
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…
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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…
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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…
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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,…
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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…
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…
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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…
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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…
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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…

