The Latest
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Stryker’s manufacturing, shipping disrupted after cyberattack
The medtech company, which identified the attack on Wednesday, revealed in an update that its order processing, manufacturing and shipping have been disrupted.
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FDA to unify agency’s ‘fragmented’ safety surveillance system
Combining the disparate databases used to detect potential issues with drugs, vaccines and other products into a single dashboard will enhance their utility and cut costs, the agency said.
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Insulet reports 18 serious adverse events with recall of Omnipod 5 insulin pumps
The company is recalling certain lots of its insulin patch pumps after finding a small tear in the internal tubing may cause insulin to leak inside the pod.
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Genetic tests come under scrutiny in Trump administration’s fraud crackdown
As the Centers for Medicare and Medicaid Services calls for public feedback on how to stop lab test fraud, experts say a tailored regulatory strategy will be key to avoid stifling innovation.
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Stryker investigating cyberattack that caused widespread outage
The full scope of the impact, including operational and financial effects, is not yet known. Stryker does not have a timeline for full restoration of its systems.
Updated March 12, 2026 -
Advita Ortho receives warning letter related to shoulder system
Advita Ortho was formed after orthopedic implant maker Exactech sold its assets in bankruptcy.
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Insulet posts clinical data on fully closed-loop insulin delivery system
The company aims to start a pivotal trial this year, file for 510(k) clearance in 2027 and launch the device in 2028.
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Vitestro raises $70M to ready blood collection robot for US launch
The company is scaling up manufacturing and commercial activities as it prepares to enter the U.S. market via the Food and Drug Administration’s de novo pathway.