Medtech Insight - News And Expert Analysis For Medtech Decision Makers since 1975

The US FDA has updated its guidance document on small business eligibility determinations for medical device firms. Industry observers urge companies to ask for the status early to avoid any potential hold-ups.

Pending legislation seeks to address what the sponsors argue is a lack of transparency in medical billing. If enacted, the bill would provide patients with the costs of procedures and medications before receiving them. A data collection expert discusses what the bill could mean for patients.

The US FDA has announced its user fees for fiscal 2026, which are based on a figure of $455,000 for a PMA.

Germany’s CorTec has implanted its wireless brain-computer interface in a stroke patient, launching a trial to test safety and whether brain stimulation during physical therapy can help restore movement where traditional rehab has failed.

The US FDA has updated its guidance document on small business eligibility determinations for medical device firms. Industry observers urge companies to ask for the status early to avoid any potential hold-ups.

Notified bodies are calling for their key role, as the technical, regulatory and clinical ‘extended arm’ of regulatory authorities, to remain central to the EU medtech conformity assessment process.

A new MRI scanner developed by a team of scientists working with the National Institutes of Health marks a milestone in understanding the complexities of the human brain. Andrea Beckel-Mitchener with the NIH Brain Initiative discusses the significance of this potentially game-changing device.

NHS England's national chief clinical information officer issued a cease and desist on unapproved ambient voice technology and AI scribes. The move caused confusion among AVT vendors and went beyond joint MHRA/NHS guidance. IMed consultant Ben Austin shares his perspective.

The medtech M&A landscape is experiencing a resurgence fueled by significant capital from private equity and venture firms, says Alex Wakefield, CRO of AcuityMD. Building strong relationships with physicians remains crucial in medtech, and defining an exit strategy early is imperative.

The Cancer Research Horizons Innovation Awards took place on July 10. Medtech Insight spoke to nominees for the women’s entrepreneur of the year award: Mireia Crispin-Ortuzar, CEO of 52 North Health; Anita Grigoriadis, CEO of PharosAI; and Maria Giovanna Lizio, Founder of WILD-Imaging Technology.

The Milner Institute, the on-campus hub for start-up acceleration at Cambridge University, hosted its annual Pitch Day on July 1. Start-ups Panakeia, PathwayBio and Sentinal4D presented diagnostic technologies.

Dexcom’s CEO Kevin Sayer discusses this fall’s planned launch of the 15-day G7 CGM, downplays Abbott’s dual-sensor while focusing on development of multi-analyte G8, making OTC Stelo app more “consumerish” for Europeans, and more.