The Latest
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Note from the Editor-in-Chief
A change in ownership and what it means for our readers.
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FDA issues final guidance on postmarket updates to AI-enabled devices
By using pre-determined change control plans, manufacturers can update AI-enabled devices without filing an additional FDA submission.
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Q&A
How CMR Surgical is taking on robotics’ ‘800-pound gorilla’
“I don't think a monopoly market is healthy,” said CMR co-founder Mark Slack, discussing robotic surgery pioneer Intuitive Surgical’s continuing dominance in the market.
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Movano receives FDA nod for smart ring’s pulse oximeter feature
Movano Health plans to market the Evie Ring to organizations that run clinical trials and healthcare companies that are helping patients manage chronic diseases.
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GE Healthcare to buy radiopharmaceutical firm Nihon Medi-Physics
GE Healthcare has identified radiopharmaceuticals as a growth driver for the company and Japan as a key market.
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J&J appoints Shawn Millerick to lead vision care unit in the Americas
Millerick, who spent time at Abbott and Alcon, is responsible for defining strategy and driving growth at a J&J business that sells products including Acuvue contact lenses.
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Guardant awarded nearly $293M in false ad trial against Natera
Natera allegedly made “false and misleading statements” to convince people to use its Signatera cancer test rather than Guardant’s rival product Reveal.
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Advamed CEO stresses need for safety, efficacy after Trump picks Makary to lead FDA
Martin Makary, a Johns Hopkins surgeon and researcher, has been critical of the FDA. He could have the most influence over device policy among Trump’s nominees.
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Biden administration proposes Medicare, Medicaid coverage of pricey weight loss drugs
About 7.4 million Americans with obesity could have insurance coverage for drugs like Wegovy if the Trump administration allows the rule to go into effect — at the cost of $40 billion to federal and state governments.
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Medtronic wins VA contract to install AI-powered endoscopy units
The three-year contract expands Medtronic’s work with the VA to cover the installation of almost 100 more GI Genius endoscopy modules at U.S. centers.
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Embecta discontinues insulin patch pump development
CEO Dev Kurdikar said the decision may “come as a surprise” as Embecta just received FDA clearance for a patch pump, but the company “did not intend to do a full market launch of this product.”
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Zimmer wins FDA approval for cementless partial knee implant
The device is established in Europe, where the company said it has a 60% market share, but will be the first product of its type available in the U.S.
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Trump calls for 25% tariffs on imports from Canada and Mexico
The president-elect also called for additional 10% tariffs on imports from China as part of his day one White House plans.
Updated Nov. 26, 2024 -
Boston Scientific to buy Intera Oncology, maker of liver cancer treatment
Intera makes a pump and a chemotherapy drug to treat liver tumors. Boston Scientific sees the purchase as a way to provide more comprehensive cancer treatments.
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Johns Hopkins surgeon Makary is Trump’s pick to lead FDA
A prolific medical researcher and author, Martin Makary criticized the FDA and CDC for their decision-making during the pandemic, although he describes himself as pro-vaccine.
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Medtronic, Tempus testing AI to find potential TAVR patients
The randomized trial will use Tempus’ platform to find patients who are eligible for interventions such as TAVR but do not have a treatment plan in place.
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Medtronic buys surgical instrument developer Fortimedix
Fortimedix develops flexible surgical instruments that are responsive enough to navigate the body and enable endoscopic and minimally invasive procedures.
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FDA plan would alert public sooner on high-risk device recalls
The Center for Devices and Radiological Health’s pilot program is meant to cut the time between the FDA’s awareness of potentially high-risk recalls and when the public is notified.