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‘Refuse to Accept’ Decisions For Cyber Devices To Begin In October
The US FDA is giving sponsors a grace period of six months before it will issue “refuse to accept” decisions for premarket submissions for cyber devices that lack the information required under recent cyber amendments.
LSI 2023: Intuitive Alums On Dawning Of Robotic Surgery To Digital OR Future
Robotic surgery pioneer and co-founder of Intuitive Surgical Frederic Moll joined Daniel Hawkins, Intuitive’s first non-technical hire, for a discussion on the evolution of surgical robotics and outlook for the future.
FDA Issues Framework For Use Of Digital Health Technologies In Drug Development
The FDA’s new framework for the use of digital health technologies will engage stakeholders to provide more guidelines for the industry.
LSI 2023: What Ophthalmology Start-Ups Pitched To Investors At Emerging Medtech Summit
Leaders of burgeoning ophthalmology companies pitched innovations for treating glaucoma, macular degeneration and corneal blindness to potential investors and partners at the LSI Emerging Medtech Summit in Dana Point, CA. Here’s what Medtech Insight heard and learned in on-site interviews with chief executives.
News We’re Watching – US FDA Updates, Digital Therapeutics Legislation, AI Endoscopies, Monkeypox EUA, And New AdvaMed Chair
The US Food and Drug Administration recently issued updates regarding improvements to its online submissions portal, enhancements to its electronic medical device reporting system, pediatric X-ray guidance, expanded indications for a popular breathing device, and mammogram guidelines; and more news we’re watching.
Is Time Nearly Up For Pear? The PDT Company Could Be Bargain For Acquirer
Despite earlier efforts to restructure, the company is still struggling to meet its revenue targets, and issued a statement suggesting that further measures, including liquidation, may be necessary.
Huma Secures EU MDR Approval For Medtech Software That Can Be Used In Any Disease
Huma Therapeutics has secured the first ever EU regulatory approval for a “disease agnostic” class IIb medtech software platform. CEO Dan Vahdat tells Medtech Insight how the product can be configured to monitor patients with any condition.
Haleon’s Tess Player: Digital Self-Care Can Reduce Health Inequality And Raise Productivity
Haleon's partnership with Microsoft to include 1,500 of the former's products in the latter's Seeing AI application – which reads aloud information on packs for the visually impaired – is an example of how digitalization can help to make healthcare more inclusive, according to vice president and global head of healthcare professionals and health influencer marketing Tess Player.
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