Medical Device and Diagnostic Industry (MDDI)

Everything you need to know about 21 CFR compliance, including real-world examples of the five most common non-compliance violations and how they could have been avoided. Amanda Pedersen, Senior Editor, MD+DI, Informa Markets – Engineering The latest MD+DI webinar, sponsored by Limble and available now on demand, covers the importance of the 21 CFR (Code of Federal Regulations) for medical device manufacturers and the five most common non-compliance violations (and how to avoid them).

This three-day course, presented in three 60-minute sessions August 20, 21, and 22, will guide you through the challenges and requirements surrounding sterilization using vaporized hydrogen peroxide (VH2O2). The publication of ISO 22441:2022 and the US FDA’s recognition and 2024 reclassification of VH2O2 Established Category A process — now support wider use of this increasingly popular modality for single-use and other medical device applications.

Ajinomoto launches CELLiST AAV Production Supplement 1, boosting gene therapy viral vector productivity by 1.3-2x.

Omar Ford, Editor-in-Chief, MD+DI, Informa Markets – Engineering At a Glance CMS AI Playbook v4 mandates prompt safeguards and auditable data lineage for generative AI in hospitals. Non-compliance risks include payment denials, accreditation loss, and quality program penalties. Stricter AI oversight may slow short-term adoption but drive long-term innovation. Hospitals could be left scrambling to meet guidelines after the Centers for Medicare and Medicaid released Version 4 of its AI Playbook.

Intuitive's da Vinci SP system secures FDA clearance for hernia, gallbladder, appendix surgeries amid growing competition. Claire Wallace, Senior Writer, Informa Markets – Engineering Da Vinci 5 System Sunnyvale, CA-based Intuitive has secured extended FDA approvals for the da Vinci Single Port surgical system, which is currently used for urology, colorectal, thoracic and transoral procedures.

The news you need. In one minute or less. Amanda Pedersen, Senior Editor, MD+DI, Informa Markets – Engineering Teleflex Divests Businesses Teleflex has agreed to sell its Acute Care, Interventional Urology, and OEM businesses for a combined $2.03 billion. Intersurgical is expected to acquire Acute Care and Interventional Urology. Private equity firms Montagu and Kohlberg plan to acquire the OEM business.

Each year, the medical device industry has highs and lows. And each year, MD+DI editors take a hard look at the companies, market segments, and trends that stand out as the biggest winners and biggest losers for the industry. We previously published our list of Medtech's 10 Biggest Winners here. Now we're looking at the other side of the coin, the biggest losers.

Neuralink, Elon Musk’s neurotechnology company that has spent the last few years developing implantable brain–computer interfaces, has added FDA executive David McMullen to its team. McMullen will serve as Neuralink’s head of medical affairs, responsible for bridging clinical, research and regulatory efforts with real-world needs.

The lab at its St. Petersburg, FL, headquarters expands capabilities in minimally invasive medical device technology. Staff, Informa Markets Engineering The lab will support universities and major healthcare brands in advancing catheter development, said Jabil.

The technology paves the way for the use of the company's point-of-care electroencephalography system to address a long unmet need in delirium monitoring. Amanda Pedersen, Senior Editor, MD+DI, Informa Markets – Engineering The Ceribell System is a portable EEG platform. Ceribell said it has received FDA 510(k) clearance for its delirium monitoring solution, making it the first delirium screening and monitoring device cleared by the agency.