The BLA and MAA acceptances represent significant milestones in Polpharma Biologics' development program and underscore the company's commitment to advancing high-quality biosimilars and expanding global access to affordable biologic medicines
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Medical Devices and Biotechnology News
Fresenius Announces FDA and EMA Acceptance for Review of Vedolizumab Biosimilar Candidate
Acceptance reinforces Fresenius Kabi’s strategy to expand its autoimmune biosimilars portfolio and broaden patient access to biologic medicines
Effective August 1, 2026, the agreement allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier for BRIJ-SEAL™, joining BRIJ Medical's existing Premier Breakthrough Technology designations for Brijjit® BP-100 and Brijjit® BP-75 Force Modulating Tissue Bridges
Under the terms of the agreement, Olea Medical and Median Technologies will support the commercialization of eyonis® LCS across the United States and Europe, as well as in other geographies that may be mutually agreed upon over time
The marketing authorization is valid in all 27 European Union (“EU”) Member States, as well as Iceland, Liechtenstein and Norway. Pfizer and BioNTech have already initiated manufacturing of the monovalent XFG-adapted COVID-19 vaccine at risk to ensure supply readiness in anticipation of the respiratory disease season, when the demand for COVID-19 vaccination is expected to increase.
This collaboration is a strong strategic and financial fit for Vector," said William Jackson, CEO of Vector Science & Therapeutics Corp. and CEO of LyoGenesis Plus
Clinical Trials | Funding | Mergers & Acquisitions | Market Reports
1st Published Clinical Study Demonstrates Feasibility of Fluorescence Imaging in Orthopaedic Surgery
The Royal Orthopaedic Hospital NHS Foundation Trust researchers publish the first clinical evidence supporting the use of real-time fluorescence imaging during revision knee arthroplasty for periprosthetic joint infection
The combination empowers healthcare organizations to improve outcomes, increase efficiency, and bring back the joy of nursing
New investor Horizon 3 Healthcare led the round, which was supported by the European Innovation Council, Invest-NL, VI Partners, EQT Life Sciences, DaVita and other current shareholders
NLP in Healthcare & Life Sciences Market worth $30.06 billion by 2031 | Report by MarketsandMarkets
According to MarketsandMarkets™, the NLP in Healthcare & Life Sciences Market will grow from USD 8.14 billion in 2026 to USD 30.06 billion by 2031, at a CAGR of 29.9% during the forecast period.
Executives On the Move
Industry Expert Bylines
Dr Mohammad Dastjerdi brings deep expertise in the medical and surgical management of complex corneal and ocular surface disease, including corneal transplantation, dry eye disease, and corneal neovascularization. He joins as an associate professor and will treat patients through the NYU Langone Eye Center
CIRCA Scientific Appoints Jack Darby as Chief Executive Officer
Veteran cardiovascular medical device executive to lead Company's next phase of growth as CIRCA builds a differentiated cardiovascular access portfolio; Lee Geist transitions to Chief Operating Officer
Caristo Diagnostics Expands Executive Team With 2 Experienced Leaders
David Vort Chief has been appointed Commercial Officer and Chris Louk Chief Financial Officer
The ROADSAVER Stent System is a next-generation design featuring an innovative, dual-layer nitinol micromesh construction. The outer self-expanding nitinol scaffold provides strength and flexibility, while the inner micromesh layer serves as a continuous embolic barrier – helping to contain plaque against the vessel wall and minimize distal embolization during and after the procedure. Read what our expert has to say:
Medical devices have evolved to the point where they no longer operate as standalone products. As these products become more connected, materiovigilance, the process of monitoring and evaluating the safety and performance of medical devices after they reach the market, is becoming increasingly complex.
Hospitals
Imaging
Association News
BayCare Among First in Florida to Offer Next-Generation Breast Surgery Procedure
As BayCare continues to advance breast cancer care, robotic-assisted nipple-sparing mastectomy offers eligible patients another innovative option tailored to their medical and personal needs
Former First Baptist Medical Center Acquired By St Raphael Health – Dallas
The new ownership brings a renewed team, a more welcoming hospital experience, and stronger connections for Dallas patients, surgeons, physicians, families, and community partners
HOPPR's fifth foundation model brings its own chest CT capability to the AI Foundry portfolio, combining purpose-built models with secure infrastructure and flexible expert services that meet development teams wherever they are
Over the coming weeks, Topcon Healthcare will make GAIA commercially available in the EU with the launch of this product and a product showcase planned at the 44th European Society of Cataract and Refractive Surgery (ESCRS) from September 11-15, 2026, at the Excel, London, UK
ACC to Launch New Cardiogenic Shock Designation to Address Deadly Gap in Heart Attack Care
Additionally, a new grant will support rural hospitals in implementing designation
Hospitals that provide high-quality surgical care for older adults may now earn the Recognized Leader in Geriatric Surgery designation, a new program announced today by the American College of Surgeons (ACS) and The Leapfrog Group. The designation is awarded through a collaboration between the ACS, an organization dedicated to improving the care of surgical patients […]
