Medical Devices & Biotechnology News

FDA Approves an Autoinjector Version of LEROCHOL® (lerodalcibep-liga) and Updated Indication

August 17, 2026

FDA also approved a positive update to the LEROCHOL indication statement reflecting the well-recognized reduction of risk for major adverse cardiovascular events achieved in adults via LDL-C lowering when treated with statins or with monoclonal antibody PCSK9 inhibitors used as an add-on to statin therapy

Claremedica Able to Detect 90% of Dementia Cases at the Earliest Stage After Adopting Creyos’ Digital Cognitive Testing

August 10, 2026

Digital cognitive assessment replaces decades-old paper screening across 35+ Florida senior care sites, cutting exam time in half and identifying impairment years sooner

BioVigil Surpasses 1 Billion Hand Hygiene Opportunities, Marking a Major Milestone in Patient Safety and Infection Prevention

August 10, 2026

This milestone reflects the ongoing commitment of healthcare workers at BioVigil partner hospitals across the United States to improving hand hygiene compliance and patient safety

Amend Surgical Advances NanoFUSE® Bioactive Plug Development Through Exclusive Licensing Agreement with MLM Biologics

August 10, 2026

Through an exclusive worldwide licensing agreement with MLM Biologics, Amend has expanded its regenerative dentistry platform with a proprietary collagen technology that serves as the foundation of NanoFUSE® Bioactive Plug

Caris Precision Oncology Alliance Welcomes the University of New Mexico Comprehensive Cancer Center

August 7, 2026

Partnership expands collaborative research network dedicated to advancing precision medicine and improving outcomes for cancer patients

European Commission Authorizes Pfizer and BioNTech XFG-adapted COVID-19 Vaccine in the European Union

July 29, 2026

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.

Clinical Trials | Funding | Mergers & Acquisitions | Market Reports

Acarix Receives Regulatory Approval for the CADScor® System in the UAE

August 10, 2026

Approval opens market access across the UAE through commercial partner UniTech Solutions, bringing rapid, non-invasive coronary artery disease rule-out to point of care

P&F Products & Features GmbH Announces Acquisition of AVVie GmbH

August 5, 2026

The acquisition strengthens P&F's structural heart portfolio with the addition of the AngelValve™ Augmentation System, a novel transcatheter solution for mitral regurgitation, further expanding the company's portfolio of next-generation transcatheter heart valve therapies and reinforcing its long-term commitment to structural heart innovation

Sethera Therapeutics’ Polymacrocyclic Peptide Platform Selected for CDMRP-Supported Mutant p53 Breast Cancer Program

August 10, 2026

The work, led by Roswell Park’s Katerina Gurova, PhD, and Sethera CEO Karsten Eastman, PhD, could open a path toward targeted options for patients with aggressive tumors that have limited treatment choices

Ventilators Market worth $3.10 billion by 2031

August 10, 2026

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Executives On the Move

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Versa Vascular Appoints Bill Shields as CEO

August 11, 2026

Aegis Sciences Names Joel Galanter Interim CEO

August 7, 2026

Lane Major Appointed President and CEO of Providence™ Medical Technology

August 6, 2026

2 New Executive Leaders Appointed at Royal Health

August 6, 2026

Governance That Scales | Building a Practical AI Governance Foundation in Regulated Industries

May 22, 2026

Timing Is Biology: Integrating Circadian Physiology into Nutritional Strategy By Katherine Klyushnichenko

May 11, 2026

Dr. Thomas Rhee’s Innovative Stem Cell Cream and the Future of Preventative Care

April 14, 2026

Finding Common Regulatory Ground in AIs Growing Role within Pharmacovigilance | By: Anuradha (Annie) Prabhakar, Associate Director, Product Management, Vigilance Detect, IQVIA

April 8, 2026

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Delray Medical Center Vascular Surgeon Dr. Joseph Ricotta is First in South Florida to use SEISMIQ™ Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Lesions In The Peripheral Vasculature

August 13, 2026

Delray Medical Center and vascular surgeon, Dr. Joseph Ricotta, are the first hospital and physician in South Florida to use the SEISMIQ™ Intravascular Lithotripsy (IVL)

Blue Shield of California and Cedars-Sinai Health System Extend Long-Term Partnership Into the Next Decade

August 11, 2026

New Agreement Ensures Continued Access to Cedars-Sinai's Nationally Recognized Care, While Advancing Shared Goals for Quality, Patient Experience and Affordability

Olympus Announces Global Distribution Agreement with Endocision for Respiratory Cryobiopsy System

August 13, 2026

Portable Device is Designed to Support a Variety of Clinical Needs

Exor and Philips Extend Long-term Relationship Agreement

August 11, 2026

John Elkann, CEO of Exor, said: "We support Philips’ long-term strategy defined by innovation, value creation and disciplined execution. The updated agreement reflects our continued commitment to Philips as its largest shareholder."

The American Foundation for Suicide Prevention (AFSP) Statement on Congressional Passage of the Youth Poisoning Protection Act

August 7, 2026

The American Foundation for Suicide Prevention (AFSP) applauds Congress for passing the bipartisan Youth Poisoning Protection Act, marking a significant milestone in a years-long effort to prevent suicide by reducing access to a highly lethal means

Debbie’s Dream Foundation Joins Milken Institute’s FasterCures TRAIN Network, Expanding Opportunities to Advance Stomach Cancer Research

August 7, 2026

Participation in the FasterCures TRAIN network strengthens DDF's ability to connect researchers with the resources and relationships that accelerate stomach cancer research.