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Avicenna.AI has received the European CE Mark approval for its AI-powered tools, CINA-VCF Quantix & CINA-CSpine to detect & assess unsuspected vertebral compression fractures (VCFs) & cervical spine fractures, respectively in pts undergoing CT scans
CINA-VCF Quantix analyzes chest &/or abdomen CTs in pts (≥50yrs.), where it automatically labels vertebrae as well as calculates…
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TELA Bio has launched OviTex Inguinal in the EU for laparoscopic & robotic-assisted inguinal hernia repair; OviTex Inguinal to be showcased at EHS 2025
OviTex Inguinal is available in 2 trocar-compatible configurations, consisting of 3 or 4 layer anatomically shaped devices that provide surgeons with flexible options designed to meet pts, technique, or procedure-specific needs…
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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…

