Medtech Insight

The FDA said Boston Scientific is removing its Imager II Angiographic Catheters because a manufacturing issue could cause the catheter tip to degrade and detach during use. The company has also decided to discontinue the device. Two serious injuries and no deaths are associated with the recall.

ARPA-H is funding four competing teams to solve the same problem — too few stroke specialists, too far from too many patients — and Philips' $33.7m award is the latest piece of a $175m bet on autonomous endovascular robotics. The funding comes through the agency's Autonomous Interventions and Robotics program, or AIR, and is intended to push forward AI-enabled robotic procedure automation for stroke care.

The UK regulator's review of cobalt-chrome dual-taper modular-neck hip systems from manufacturers like Stryker and Smith+Nephew found heightened wear, corrosion and tissue-reaction risks in about 750 patients. All affected implants had already been withdrawn from the market. The systems named by the MHRA have all been pulled from the market by 2019.

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.