Medical Design & Outsourcing’s parent company, WTWH Media, rebrands as Arrowfly

Medical Design & Outsourcing’s parent company, WTWH Media, today announced it has rebranded as Arrowfly.  The new name and identity reflect the company’s transformation from a specialized trade publisher into an omnichannel B2B media, events, and marketing company where hard-to-reach professional decision-makers gather for trusted journalism, industry intelligence, and high-impact experiences that move their markets forward. Arrowfly…

The post Medical Design & Outsourcing’s parent company, WTWH Media, rebrands as Arrowfly appeared first on Medical Design and Outsourcing.

Why Navigantis thinks it can win the stroke telesurgery race

Navigantis says it has what it takes to win the race to treat stroke patients remotely with its interventional robotic platform VASCO, which is already being used in a clinical trial for neurointerventional procedures. Stroke telesurgery is one of the biggest opportunities in medtech. Major OEMs and startups barely out of stealth mode are racing…

The post Why Navigantis thinks it can win the stroke telesurgery race appeared first on Medical Design and Outsourcing.

FDA releases draft MDUFA VI agreement outlining proposed legislation and program changes

A faster pre-submission track, earlier communication for de novo applicants and an “international harmonization” pilot program are among proposed improvements and changes featured in the FDA’s latest draft Medical Device User Fee Amendments (MDUFA) agreement. The agency recently released a draft commitment letter, detailing its proposed agreement with the medtech industry for MDUFA reauthorization. If…

The post FDA releases draft MDUFA VI agreement outlining proposed legislation and program changes appeared first on Medical Design and Outsourcing.

STAT+: Dementia study replicates promising outcomes following risk-reduction strategies

This is the web edition of STAT’s AAIC in 30 newsletter. Sign up to get it in your inbox here.

Hi there from Day 2 of AAIC. There may be 10,200 people here at the Alzheimer’s Association International Conference — up 1,700 from last year — from 115 countries, as the association’s Maria Carrillo announced at Monday’s plenary session. But by far my favorite person is the woman I saw taking a nap on a bench in a corridor, her sunhat pulled over her eyes. You are an inspiration.

One housekeeping note: Due to the vagaries of newsletter scheduling, we won’t have an edition tomorrow, but will be back in your inbox with a wrap-up edition on Wednesday. Keep your eyes on statnews.com tomorrow though and expect some conference news around 9:15 a.m. Eastern.

Latin American study praised as ‘landmark’ effort

For a disease that’s proven as intractable to treat as Alzheimer’s, it’s been known for quite some time what factors can heighten one’s risk for dementia. Poor nutrition, sleep, and cardiovascular health; a lack of physical activity and social engagement; and lower education levels all increase the likelihood that a person will develop Alzheimer’s.

A study reported at last year’s AAIC put interventions designed to reduce risk to the test. The U.S. Pointer study found that an intensive, structured program that encouraged improved diet and exercise, cardiovascular health monitoring, and other steps helped protect cognitive function among older adults at risk of dementia to a greater extent than a lower-intensity program that participants navigated on their own, even as both groups saw benefits. The study underscored that healthy habits contribute to a healthy brain.

Continue to STAT+ to read the full story…

<![CDATA[New primate data show IV tau-silencing gene therapy cuts brain tau up to 75% with liver-sparing safety, clearing path for 2026 trial.]]>
<![CDATA[A panel of expert psychiatrists define deprescribing as ongoing medication review, guiding safer, personalized psychopharmacology amid polypharmacy, misdiagnosis, and fragmented care.]]>

AI Agents Are Coming: 5-Stage Taxonomy of Language-Based AI Systems for Psychiatry, Psychotherapy, and Counseling

The rapid evolution of large language models has accelerated the development of agentic artificial intelligence (AI) systems capable of pursuing autonomous goals, creating an urgent need for structural frameworks in psychiatry and psychotherapy. While existing classifications often draw parallels to autonomous driving, this paper argues that the mental health domain requires a distinct, domain-specific theoretical foundation, as the 2 domains differ fundamentally in their semantic, ideographic, and epistemological demands. Furthermore, they differ in their end goals, for which we introduce terms such as agentic guidance capability. To guide clinicians and researchers through these developments, we propose a 5-stage taxonomy for language-based AI systems that differentiates technical functionality from clinical effectiveness. The taxonomy progresses from level 1 (knowledge level), in which systems perform static benchmark tasks, to level 2 (elementary level), characterized by dynamic engagement in specific therapeutic microskills. At level 3 (integration level), systems achieve consistency across and within modules, as well as basic case-level conceptualization suitable for blended therapy under human oversight. Level 4 (saturation level) describes therapist-in-the-loop systems capable of autonomous functioning with minimal supervision, whereas level 5 (mastery level) represents AI systems that are technically capable of performing autonomous therapy. By distinguishing technical functionality from clinical effectiveness, we conclude that level 4 or level 5 performance does not automatically translate into full treatment effectiveness, even if high treatment fidelity can be achieved. We conclude by emphasizing the need to shift benchmarking from static knowledge tests to dynamic evaluations of therapeutic capabilities in order to safely navigate the transition toward autonomous care.
<img src="https://jmir-production.s3.us-east-2.amazonaws.com/thumbs/24bd74c372b92b7db87be2834a55944b" />

STAT+: UnitedHealth’s questionable review, and more MA stars lawsuits

This is the online version of STAT’s weekly email newsletter Health Care Inc. Sign up here.

I first visited a Buc-ee’s a few years ago in Kentucky on a road trip. It’s a melting pot of American culture and consumerism (with a really good cherry limeade pop). It’s also apparently an aggressive trademark litigator over its beaver mascot. Take a pit stop and share your news and tips here: bob.herman@statnews.com.

[Tim Robinson voice] You sure about that?

UnitedHealth Group was happy to promote a new audit that said nearly all of the diagnoses recorded for its Medicare Advantage members during home visits (97%) were justified by medical records. But the results are not nearly as clean, or useful, as the company suggests.

Continue to STAT+ to read the full story…

Martha Lillard, last U.S. polio patient using iron lung, dies at 78 in Oklahoma

Martha Lillard had just turned 5 when she was diagnosed with polio and depended on an iron lung to live. She died June 26 in Oklahoma, the last U.S. polio patient who used the machine, her sister said. She was 78.

“They told her she wasn’t supposed to live past 20 years old,” Lillard’s younger sister, Cindy McVey, told The Associated Press on Friday. “She had the enthusiasm and the drive to continue living and make the best of her life.”

Read the rest…