Natera’s Solomon Moshkevich discussed the growing role of molecular residual disease testing to guide cancer treatment, a recent FDA approval and progress in early detection in an interview with MedTech Dive. https://lnkd.in/gQ8PVjcP
MedTech Dive
Online Media
Washington, District of Columbia 24,747 followers
Business journalism and in-depth insight into news and trends shaping medical technology
About us
MedTech Dive brings you in-depth journalism and insight into the news and trends shaping the business of medical technology. Subscribe for our free daily newsletter to learn about medical devices, diagnostics, M&A, digital health, FDA regulation/compliance, R&D, imaging and more. MedTech Dive is published by Industry Dive. Our business journalists spark ideas and shape agendas for 13+ million decision-makers.
- Website
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https://www.medtechdive.com/signup/
External link for MedTech Dive
- Industry
- Online Media
- Company size
- 201-500 employees
- Headquarters
- Washington, District of Columbia
- Founded
- 2018
- Specialties
- Medical Technology, medical devices, medical imaging, diabetes technology
Updates
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California’s attorney general filed a lawsuit against the genetic testing company formerly known as 23andMe following a 2023 data breach that affected nearly 7 million people. The complaint alleges 23andMe failed to implement reasonable security procedures and made misleading statements about its security and the data breach. If the case is successful, civil penalties imposed on the company could be in the “multiple millions,” California Attorney General Rob Bonta said in a press conference. https://lnkd.in/gfT3psuq
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Johnson & Johnson’s Abiomed has recalled seven Impella CP Sets with SmartAssist that do not meet design specifications, after an internal review. A spokesperson said J&J completed a number of retrospective audits as part of the integration of its Abiomed acquisition that led to recent field actions. https://lnkd.in/gVuPhCYW
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ŌURA plans to add a blood pressure feature following the launch of its latest smart ring. The blood pressure tool would be presented as a wellness feature, not a medical device, showing trends in overnight changes to blood pressure but not providing specific systolic and diastolic readings. Oura is working on a separate study of a feature to surface hypertension risk that would be regulated by the FDA. https://lnkd.in/gYk5G5fZ
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Siemens Healthineers has agreed to integrate its MRI scanners with AiM Medical Robotics' neurosurgery system. Elsewhere, PROCEPT BioRobotics finished enrolling patients in a study comparing its aquablation therapy to prostatectomy. https://lnkd.in/gFkmiXYD
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The FDA continues to receive more medical device submissions with #AI. As of the agency's latest update, the device center had authorized more than 1,400 AI-enabled devices since 1995. https://lnkd.in/gU6yhfx4
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Abbott has received Europe's CE mark for its first dual glucose-ketone sensor, called Libre Duo. The technology is intended to help people manage their diabetes and detect rising ketone levels, which can be an indication of a serious health condition called diabetic ketoacidosis. Abbott plans to launch the devices in some European countries later this year. https://lnkd.in/gqwXDipR
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Cornerstone Robotics said its Sentire surgical system received Europe’s CE mark to perform procedures in general surgery, gynecology, thoracic surgery and urology. https://lnkd.in/gbSiNmkm
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Johnson & Johnson’s orthopedics business said Tuesday it has struck a deal with French medtech firm MinMaxMedical to buy radiofrequency technology for real-time tracking during procedures. The J&J unit is buying the technology for an undisclosed amount, and will have selective rights to develop, manufacture and commercialize the technology. https://lnkd.in/g8QnrbCs
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Insulet Corporation is recalling 7 million patch pumps due to a manufacturing issue where devices may have a small tear in the tubing. The problem can cause insulin to leak, posing the risk of hyperglycemia and related complications. The correction applies to certain lots of Insulet’s Omnipod 5, Omnipod DASH and Omnipod Insulin Management System devices. Insulet said it expects to incur up to $50 million in costs this year related to the action. https://lnkd.in/gW7WumzS