The US FDA Approves MED-EL’s Sonnet 3 Audio Processor for Optimal Hearing

Shots: The US FDA has approved the Sonnet 3 audio processor for MED-EL cochlear implants; commercially available in early 2025. Also, Pts implanted with MED-EL as of Sep 1, 2024, can access one-time exchange for Sonnet 3 in the TechSwap Program Sonnet 3 is 2g lighter & ~18% shorter than Sonnet 2 with features…

ByRidhi RastogiFebruary 18, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (February 10th, 2025 – February 14th, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health & Biosimilars. Check out our full report below: Eli Lilly Reveals VIVID-2 Study Data of Omvoh to Treat Crohn's Disease Read More: Eli Lilly Regeneron Reveals Data from Extended P-III (PULSAR) Trial of Eylea HD for Wet Age-related Macular Degeneration Read…

BySenior EditorFebruary 14, 2025

NEWS

Johnson & Johnson MedTech Launches Cereglide 92 Catheter System in the US for Acute Ischemic Stroke

Shots: J&J MedTech has launched the Cereglide 92 Catheter System with the Innerglide 9 delivery aid in the US to ease insertion & guidance of interventional devices in the neurovascular system Cereglide 92 features a .092” inner diameter with Innerglide 9 delivery aid, Brite-line tech for complete catheter visibility, & TruCourse for flexibility to…

ByRidhi RastogiFebruary 13, 2025

NEWS

Ibex Medical Analytics Receives the US FDA’s 510(k) Clearance for Ibex Prostate Detect

Shots: The US FDA has granted 510(k) clearance to Ibex Prostate Detect, which generates heatmaps using AI to detect small & rare missed prostatic cancers In studies, the device showed 99.6% PPV for cancer heatmap accuracy & detected 13% rate of missed cancer in pts initially diagnosed as benign, where these false negatives were later confirmed…

ByRidhi RastogiFebruary 11, 2025

NEWS

AliveDx Seeks US FDA’s 510(k) Clearance for MosaiQ AiPlex Multiplex Microarray

Shots: The US FDA has received 510(k) Application for MosaiQ AiPlex Multiplex Microarray to improve & accelerate diagnosis of celiac disease MosaiQ simplifies serological evaluation with syndromic approach by combining IgA & IgG isotypes to detect IgA deficiency & measure anti-tTG as well as anti-DGP (AU/mL) using just 20 μL of sample in single…

ByRidhi RastogiFebruary 10, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (February 3, 2025 – February 7, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health & DigiHealth. Check out our full report below: Algiax Pharmaceuticals Reports Topline Data from P-IIa Trial of AP-325 for Neuropathic Pain Read More: Algiax Pharmaceuticals Pfizer Reveals Data from the P-III (BREAKWATER) trial of Braftovi Regimen in Patients with Metastatic…

BySenior EditorFebruary 7, 2025

NEWS

Senseonics Seeks the CE Mark Approval for Eversense 365 System

Shots: Senseonics has filed for the CE Mark Approval of its Eversense 365 CGM system. If approved, it will be distributed in the EU (Germany, Italy, Spain, Poland, Switzerland, Sweden, & Andorra) by Ascensia Diabetes Care (Senseonics' commercial partner) Eversense offers longevity (1yr. vs 10-14 days for traditional CGMs), features a removable smart transmitter…

ByRidhi RastogiFebruary 7, 2025

NEWS

Gyder Surgical Reports the US FDA’s 510(k) Clearance for Gyder Hip System

Shots: The US FDA has granted 510(k) clearance to the Gyder Hip System for positioning of the acetabular cup during anterior hip arthroplasty following approval from Australia’s TGA Gyder Hip System eliminates the use of metallic pins & pre-operative/intra-operative imaging for landmark registration, offering a less invasive approach than conventional hip navigation System features 1min…

ByRidhi RastogiFebruary 5, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (January 27, 2025 – January 31, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars, Animal Health & DigiHealth. Check out our full report below: Merck and Eisai Reveal Latest Data from P-III (LEAP-015) Trial of Keytruda (pembrolizumab) and Lenvima (lenvatinib) Regimen to Treat Gastroesophageal Adenocarcinoma Read More: Merck and Eisai Novo Nordisk Completes P-Ib/IIa Study…

BySenior EditorJanuary 31, 2025

NEWS

Life Spine Receives US FDA’s 510(k) Clearance for ProLift Pivot Expandable Spacer System

Shots: The US FDA has granted 510(k) clearance to Prolift Pivot expandable spacer system, expanding Life Spine’s Micro Invasive tech portfolio The system provides full articulation for precise spinal fusion, while reducing tissue disruption & nerve retraction, allowing surgeons to restore patient alignment with superior control & efficiency. It also features OSSEO-LOC surface tech that promotes osseointegration & long-term…

ByDipanshu DixitJanuary 30, 2025

The US FDA Approves MED-EL’s Sonnet 3 Audio Processor for Optimal Hearing

PharmaShots Weekly Snapshots (February 10th, 2025 – February 14th, 2025)

Johnson & Johnson MedTech Launches Cereglide 92 Catheter System in the US for Acute Ischemic Stroke

Ibex Medical Analytics Receives the US FDA’s 510(k) Clearance for Ibex Prostate Detect

AliveDx Seeks US FDA’s 510(k) Clearance for MosaiQ AiPlex Multiplex Microarray

PharmaShots Weekly Snapshots (February 3, 2025 – February 7, 2025)

Senseonics Seeks the CE Mark Approval for Eversense 365 System

Gyder Surgical Reports the US FDA’s 510(k) Clearance for Gyder Hip System

PharmaShots Weekly Snapshots (January 27, 2025 – January 31, 2025)

Life Spine Receives US FDA’s 510(k) Clearance for ProLift Pivot Expandable Spacer System

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