FDA Dataset Helps Firms Scrutinize Third-Party Chemistry Labs
Medical devices that contact the human body undergo biocompatibility safety assessments prior to market release, including tests for physiochemical properties. The Food and Drug Administration’s (FDA) Center for Devices and...
Johnson & Johnson to Acquire Shockwave Medical in $13.1B Deal
Johnson & Johnson (J&J) reported on April 5, 2024, that it has entered an agreement to acquire Shockwave Medical, a company in the cardiovascular medical device sector, in a deal...
Orthobond Received FDA De Novo Approval for Antibacterial Technology
Orthobond received on April 5th de novo approval for the company’s spinal fusion device with quaternary ammonium compound coating. Orthobond’s antibacterial treatment, Ostaguard™, covalently bonds its antimicrobial, polycationic molecules to...
3M Spins Off Healthcare Business Solventum
3M recently completed the spinoff of its healthcare technology business as the new standalone public company, Solventum Corporation. Solventum has an IP portfolio with over 7,300 patents globally. Solventum operates...
Titan Medical Merges with Conavi Medical
Titan Medical Inc. (“Titan”) announced on March 18, 2024, that it is merging with Conavi Medical Inc. (“Conavi”). Titan is a medical technology licensing company based in Toronto with an...
New Ethylene Oxide Regulations may Raise Cost of Sterilization
Last week, the Environmental Protection Agency (EPA) announced new regulations to reduce ethylene oxide emissions. According to the EPA’s press release, the new regulations are “the strongest measures in U.S....
DarioHealth Acquires Digital Health Company Twill for $22.4 Million
(February 22, 2024) Dario health announced on February 21, 2024 that it has acquired digital health company Twill. DarioHealth Corp. is a leading digital health company, shaping how people with...
Expect Future FDA Clarification on Machine Learning-Enabled Medical Devices
The inaugural AAMI/FDA neXus medical device standards conference was held February 20-23, 2024 in Washington DC. The conference was hosted by the Association for the Advancement of Medical Instrumentation (AAMI)....
FDA Issues Warning about Fraudulent and Unreliable Laboratory Data
The U.S. Food and Drug Administration (FDA) recently issued a Letter to Industry warning medical device manufacturers and device study sponsors (“device firms”) of a source of “fraudulent and unreliable...
FDA Approves Edwards EVOQUE® Tricuspid Valve Replacement System
The U.S. Food and Drug Administration (“FDA”) recently approved the Edwards EVOQUE® Tricuspid Valve Replacement System (the “EVOQUE® system”) for use in treating Tricuspid Regurgitation (“TR”). The EVOQUE® system is...
World Health Organization Releases Guidelines for Large Multi-Modal Models (LMMs)
The World Health Organization (WHO) recently released guidelines for the ethics and governance of large multi-modal models (LMMs). In the past year, LMMs like Chat GPT have come...
Deep Brain Simulation Devices Market Expected to Reach USD 3.5 Billion by 2033
A recent paper published by market.us projects that the Deep Brain Stimulation (DBS) devices market is expected to reach around $3.5 Billion by 2033, compared to the projected $1.5 Billion...
