Approvals
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
New UAE Regulator Calls On Drug and Device Companies To Help Shape Mandate
Facilitating and strengthening R&D, intellectual property rights protection and drug safety are among the goals of the soon-to-be-launched Emirates Drug Establishment. Despite the name, the entity is also responsible for device regulation.
News We’re Watching: FDA Approves Medtronic's Affera, Roche's CGM Moves Closer To Approval, And More
Medtech Insight's News We're Watching covers medtech industry and research news you may have missed. This week, the Advanced Technologies and Treatments for Diabetes (ATTD) conference in Florence, Italy, included new results from studies of Roche's continuous glucose monitor and Medtronic's 780G insulin pump, Medtronic moved closer to earning FDA approval for its Affera ablation mapping and ablation system, and Linus Health expanded its technology for finding signs of cognitive problems in speech data.
News We’re Watching: First OTC Blood Glucose Monitor, Recalls For Ventec and Medtronic, Guidance Docs Under White House Review
This week, the US FDA announced that it had cleared Dexcom’s Stelo Glucose Biosensor System, making it the first OTC device of its type available in the US. Additionally, the Office of Management and Budget took up guidance documents on cybersecurity and enforcement on diagnostics during emergencies, and recalls were announced by Medtronic, Ventec and Cardinal.
Dexcom CEO Talks Stelo Launch, Broader Plans, And GLP1 Misconceptions
Medtech Insight spoke to Dexcom CEO Kevin Sayer, ahead of this year’s Advanced Technologies & Treatments for Diabetes conference, to get an update on the company’s recent news, future strategy and where he feels his company’s market is headed.
New’s We’re Watching: J&J's Varipulse PFA Earns CE Mark; Labs Create Intravascular Robots; And More
Medtech Insight's News We're Watching highlights some recent business and R&D developments you may have missed. This week, Biosense Webster’s Varipulse PFA platform earned a CE mark; Biosense Webster also announced the start the pivotal IDE study of its Laminar left atrial appendage elimination system; the FDA approved Boston Scientific's Agent paclitaxel-coated balloon and cleared Medtronic's OsteoCool 2.0 bone ablation system; three papers in Science Robotics describe magnetically controlled vascular robots that could go places wires and catheters cannot.
Cardio Conversations: ‘Much More Than Just A Patch,’ iRhythm CEO Blackford Talks AI Arrhythmia Diagnostics
iRhythm CEO Quentin Blackford returned to Medtech Insight’s Cardio Conversations podcast to talk about the launch of his company’s new Zio monitor patch supported by a sophisticated neural network. He also addressed the company’s plans to improve its position in the mobile cardiac telemetry market, the impact of pulsed field ablation on the cardiac monitoring business, and more.
News We’re Watching: New Cybersecurity Standard; CMS Prodded On TCET; Olympus Scopes Recalled
This week, NIST published a new version of its international cybersecurity standard; SeaStar Medical’s kidney device got an HDE; and the FDA announced safety issues for DT MedTech LLC, operating room tables, and GE incubators.
'There Is Work To Do:' Sean Salmon Discusses Medtronic's Recent Hard-Won Cardio Breakthroughs
Medtech Insight caught up with Sean Salmon, the president of Medtronic's cardiovascular business, to talk about the long-awaited FDA approval of the Symplicity Spyral renal denervation system, recent approvals of the PulseSelect pulsed field ablation system and extravascular ICD, and the company's plans for transcatheter aortic valve replacement.
News We're Watching: Tricuspid Procedure Boom, Boston Scientific Borrows $2Bn, And More
Medtech Insight's News We're Watching highlights some recent business and R&D developments you may have missed. This week, GE Healthcare and Biofourmis announced a deal to collaborate on virtual care; Cleerly touts a new CPT code for its Ischemia cardiac diagnostic software; Boston Scientific announced how it plans to pay for Axonics; a Wells Fargo survey suggests the market for transcatheter tricuspid valve repair and replacement will grow faster than previously imagined; Virtual Incision earns FDA de novo authorization for its MIRA miniaturized surgical system for colectomy procedures; and MMI and Fabric announce major financing rounds.
News We’re Watching: Smart Watch Blood Glucose Warning, $100M For Women’s Health, Zimmer Surgical Robot Clearance
This week, the FDA reminded consumers that smart watches and rings are not blood glucose monitors; First Lady Jill Biden announced a $100M women’s health initiative; and the Zimmer ROSA Shoulder System got FDA clearance.
Masimo’s MightySat Receives First FDA Clearance For OTC Pulse Oximeter
The first clearance from the US Food and Drug Administration for an over-the-counter fingertip pulse oximeter has gone to Masimo's MightySat Medical, which is now available at the company's website.
News We're Watching: Accenture Expects 'More Human' Tech, Cardiac Genetic Tests In Walmart; And More
Medtech Insight's News We're Watching highlights a few noteworthy industry developments you might have missed: Accenture's new Vision Report addresses the future of "more human" tech in health care; Efemoral secures FDA's breakthrough status for its bioresorbable peripheral stent; Impulse Dynamics secures $135m to support its cardiac contractility modulation; PrecisionLife and Metrodora announced a partnership to address chronic diseases including long COVID; Cardio Diagnostics launches its cardiac epigenetic/genetic tests in a Walmart near Chicago.
News We’re Watching: CDRH’s Maisel Announces Retirement, Fresenius Clearance, Philips and Smiths Recalls
This week, a device center stalwart prepared to say goodbye; the FDA cleared Fresenius's 5008X Hemodialysis System; and class I recalls for Smiths Medical and Philips Imaging were announced.
FDA Clears AI Software Designed To Detect Early Signs Of Fatty Liver Disease
The US FDA has cleared an AI software diagnostic product from an Israeli firm designed to detect a type of fatty liver, which is often an early indication of serious liver disease.
FDA AdCom Will Scrutinize Placebo Benefit Of Abbott’s TriClip G4 TTVR
An FDA advisory panel will discuss Abbott’s PMA for the TriClip G4 transcatheter tricuspid valve repair device on 13 February. The group’s discussion will likely focus on the lack of a clear mortality or hospitalization benefit in the TRILUMINATE pivotal trial.
News We're Watching: AliveCor Suit Dismissed, IMDRF Comes To DC, Digital Health Caucus
This week, AliveCor's patent infringement lawsuit against Apple came to an end; industry stakeholders submitted comments to the FTC on the right to repair; Cardinal Health and Percussionaire announced recalls; and the IMDRF announced a March meeting in Washington, DC.
You must sign in to use this functionality
Authentication.SignIn.HeadSignInHeader
Email Article
All set! This article has been sent to my@email.address.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.