Medtech Insight

CorTec said it received a second breakthrough device designation for its investigational Brain Interchange device for use to help people with non-progressive quadriplegia communicate. In April, the German BCI company received the same designation for use in stroke-related impairments.

A Delaware federal court has entered a $245.2m judgment in favor of TwinStrand Biosciences in a patent infringement case against Guardant Health, which plans to appeal on the grounds that covered products have since been discontinued or significantly upgraded. Guardant Health plans to appeal a $245.2m patent infringement judgment handed down by a Delaware federal court.

Sword Health plans to acquire digital mental health company Headspace in an all-cash deal valued up to $300m, according to a regulatory filing. Sword Health plans to acquire digital mental health company Headspace in an all-cash deal valued up to $300m, according to a regulatory filing. • Source: Shutterstock Sword Health plans to acquire digital mental health company Headspace for up to $300m in an all-cash deal, according to published reports.

Combining long reads with AI, pangenome references and diploid assembly could dramatically improve genetic disease diagnosis, researchers say. Alexander Hoischen with PacBio's long read sequencing machines (Eric Scholten) Key Takeaways Advances in long-read genomic sequencing are providing more insights into the human genome than ever, advancing the field closer to complete sequencing.

The FDA has selected Epitel's wearable EEG system and Prapela's infant cardiac device as the first participants in its READI-Home Innovation Challenge, which aims to cut hospital readmissions. Up to nine devices may be selected; submissions close Sept. 30.

A survey of 194 life sciences and medtech professionals showed that 63% expect AI investments to rise in 2027 with the highest investment in commissioning, qualification and validation (CQV), according to Axendia. But only half of surveyed respondents rate their company’s data quality as sufficient. A survey of 194 life sciences professionals and technology providers –35% of whom work in the medtech industry – found that respondents expect AI spending to rise in the coming year.

A Pew survey of 3,488 US adults finds 72% want to be told if AI is used in their care and 46% do not know if it has already happened — a transparency gap that may matter more to public trust in healthcare AI than adoption rates alone. The survey of 3,488 US adults, conducted June 22–28, found that 72% consider it extremely or very important that a doctor or other provider inform them when AI is used in their healthcare.

The FDA has issued another early alert involving Abiomed’s Automated Impella Controllers, citing a purge cassette recognition problem. Three deaths and 37 serious injuries have been linked to the alert, which follows a series of recent safety events involving the Impella system. (Shutterstock) The US Food and Drug Administration has issued another early alert concerning Automated Impella Controllers from Johnson & Johnson’s Abiomed.

Execs On The Move: August 17–21, 2026 An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.

Chirag Patel built BAiO around deliberate constraints — no diagnosis, no prediction, no autonomous decisions — and is frank that the category it sits in earned its skepticism long before BAiO arrived. The platform runs on nCyte, an engine built over 10 years with input from doctors, performance and data scientists, trainers, psychologists and coaches.