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AI-Based Screening Tool For Musculoskeletal Issues Gets US FDA Warning Letter

 
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Exer Labs Inc.’s website marketed its AI-based Exer Scan app to “screen and treat Parkinson’s, TB, Cerebral Palsy and more.” But those claims went well beyond what was allowed under the product’s 510(k) clearance, US regulators say.

Wired Health: ‘Early Diagnosis Often Benefits Science But Not The Patient’

 

Early diagnosis can be “detrimental” to patients, Suzanne O'Sullivan, neurologist and author of “The Age of Diagnosis,” argued at the Wired Health conference on 18 March. "You save one life from screening 2,000 women for breast cancer, but you also treat 10 women unnecessarily," she said.

LSI 2025: Intuitive Surgical CEO Gary Guthart On da Vinci 5’s Force Feedback, Digital Coaching, ION Expansion, And Robotic Surgery’s Future

 
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Medtech Insight sat down with Intuitive Surgical CEO Gary Guthart at the recent LSI USA conference to discuss the full launch of the new da Vinci 5 robotic system and planned digital enhancements. Guthart also offered his views on health care interoperability, AI regulation, outpatient surgeries, autonomous robots, and how the company is harnessing technology to shape the future of robotic surgery.

US FDA Should Regulate ‘Dangerous’ Prescription Software Platform As A Medical Device, Says Patient Advocacy Group

The Doctor Patient Forum says the US FDA should regulate a scoring platform from Bamboo Health intended to help clinicians calculate risk for opioid abuse as a medical device to ensure patient safety.

23andMe Files For Bankruptcy, Raising Fresh Concerns Over Fate Of Genetic Data

23andMe has filed for Chapter 11 bankruptcy and announced the resignation of founder and CEO Anne Wojcicki. Privacy concerns surrounding the sale of its extensive genetic database remain after a 2023 data breach exposed data from some 7 million users. Experts warn that bankruptcy proceedings could lead to consumer data being sold, raising questions about legal protections and consumer rights.

European Medicine Agency’s CHMP Qualifies First AI Tool For Use In Clinical Trials

 

With the support of AIM-MASH AI Assist only one pathologist is needed to reliably make a histology assessment of inflammatory liver disease to decide whether patients should be included in MASH clinical trials.

Barcelona’s S2 Xpeed Accelerates Hardware-Based Medtech Start-Ups From Prototype To Market

 
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Barcelona-based accelerator S2 Xpeed is driving the rapid growth of medtech and hardware start-ups in Europe. Operating under a "sweat equity" model, the program helps early-stage companies move from prototype to manufacturing readiness in exchange for equity. This month, the accelerator will add a fourth cohort of 10 more start-ups, five of which are in the medtech space.

Wired Health: Women Of Wearables Shares Market Outlook

 

Medtech Insight sat down with Anja Streicher, chief marketing officer at Women of Wearables, a global community offering events and education resources to support the femtech industry, to discuss trends in the women's wearables tech market, challenges and innovators pushing the boundaries.