News about Market

Amber Implants Secures FDA 510(k) Clearance for VCFix Spinal System

The VCFix Spinal System, a novel treatment for vertebral compression fractures, has received FDA clearance following one-year trial results that confirmed its safety, performance, and significant clinical benefits. A US commercial pilot launch is planned for early 2026, with broader physician availability expected by summer 2026.

Market | 19/09/2025 | By Dineshwori |  334

Singapore fast-tracks medtech innovation with first regulatory reliance pilot: GlobalData

The six-month pilot of the Medical Device Regulatory Reliance Programme, running from 1 September, 2025 to 28 February, 2026, aims to expedite market access for Class B, C and D medical devices by reducing duplicate regulatory reviews and leveraging each other's approvals.

Market | 18/09/2025 | By Dineshwori |  206

VarmX and CSL Sign Deal Worth up to USD 2.2 Billion

Under the agreement, CSL will fully fund clinical development of VMX-C001 and pay VarmX shareholders USD 117 million upfront for an exclusive option to acquire VarmX, in a transaction worth up to USD 2.2 billion

Market | 17/09/2025 | By Dineshwori |  265

ExSight Ventures Invests in RevOpsis Therapeutics to Develop Eye Disease Therapies

RevOpsis is developing a novel class of multi-specific antibody-based treatments designed to address significant unmet needs in ophthalmology, with an initial focus on wet Age-related Macular Degeneration (AMD) and diabetic eye disease.

Market | 17/09/2025 | By Dineshwori |  231

Sanguine Expands Oncology Biospecimen Access via Clinic Partnerships

Through these partnerships, Sanguine now offers researchers access to a growing inventory of oncology biospecimens, including blood, plasma, serum and peripheral blood mononuclear cells (PBMCs), collected using minimally invasive methods to reduce donor burden and accelerate study timelines.

Market | 17/09/2025 | By Dineshwori |  191

Ocugen and Kwangdong Finalise OCU400 Gene Therapy Deal for Retinitis Pigmentosa in Korea

Pursuant to the licence agreement, Ocugen will receive upfront license fees and near-term development milestones equaling up to USD 7.5 million. The company will be entitled to sales milestones of USD 1.5 million for every USD 15 million of sales in Korea, projected to reach USD 180 million or more in the first 10 years of commercialisation.

Market | 17/09/2025 | By Dineshwori |  651

Sagent Pharmaceuticals Enters Ophthalmic Market, Launches Travoprost Ophthalmic Solution

Travoprost is the first ophthalmic product offering in Sagent's portfolio, with plans to launch more products in the coming year.

Market | 16/09/2025 | By Dineshwori |  319

REFCOLD India 2025 to Showcase Cold-Chain Innovations in Delhi

REFCOLD India 2025 will feature specialised platforms such as the innovation zone, demo zone, product launch pad, celebrating the next generation of engineers through a global student poster competition and outdoor displays, spotlighting next-generation technologies across multiple refrigeration applications.

Market | 16/09/2025 | By Dineshwori |  537

B Braun Acquires True Digital Surgery

Before the acquisition, B Braun held a minority stake in TDS. The decision to fully acquire TDS allows B Braun's surgical division Aesculap to secure the valuable expertise of the TDS team, ensuring the continuous technological advancement of Aesculap AEOS.

Market | 13/09/2025 | By Dineshwori |  380

Pulnovo Wins Two IDE Approvals for PADN Trials with CMS Coverage

Following the FDA's BDD designation granted in 2021 for Group- I, II and IV, the newly-obtained IDE approvals for Pulnovo Medical’s PADN with CMS coverage will advance clinical studies targeting Groups-I and II into the IDE stage.

Market | 13/09/2025 | By Dineshwori |  284