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Teleflex to close Minnesota facility, cut 101 employees
Teleflex is closing its Maple Grove, Minnesota manufacturing facility by March 2026, resulting in the loss of 101 jobs, as part of a restructuring effort following the company's announcement to split into two public entities.
Madeleine DeSpirito
Apr 131 min read
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Building a Design History File (DHF): Key Documentation for FDA Compliance
A Design History File (DHF) is a crucial component of medical device development.
Madeleine DeSpirito
Apr 132 min read
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Top Preclinical Tests Needed for Medical Device Approval: What to Know Before You Begin
Medical devices must undergo extensive testing before being developed and approved to guarantee patient safety and efficacy.
Madeleine DeSpirito
Apr 64 min read
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How to Write a Comprehensive Risk Management Plan for Medical Devices
This article will guide you through developing a risk management plan for medical devices, focusing on risk analysis.
Madeleine DeSpirito
Apr 64 min read
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CMR Surgical secures $200M for US robot rollout
Launching Versius in the U.S. is a top priority for CMR, which claims the system is the second most adopted soft tissue robot globally.
Madeleine DeSpirito
Apr 22 min read
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AdvaMed repeats call for tariff exemption as new levies threaten healthcare supply chain
Lobby groups like AdvaMed and the American Hospital Association have so far failed to get medical devices and critical supplies carved out.
Madeleine DeSpirito
Apr 23 min read
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Abbott gets FDA nod to begin IVL trial after rivals buy up competition
J&J acquired the IVL device maker Shockwave Medical last year for $13.1 billion, Boston Scientific agreed to buy Bolt Medical in January.
Madeleine DeSpirito
Mar 272 min read
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HHS to cut 10,000 employees in major restructuring under RFK Jr.
Health secretary Robert F. Kennedy Jr. plans to dramatically reshape the CDC department he leads.
Madeleine DeSpirito
Mar 274 min read
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Abbott snags early CE mark for Volt PFA device
With PFA becoming physicians’ preferred ablation method for treating AFib, Abbott is pushing to catch up with rival systems.
Madeleine DeSpirito
Mar 272 min read
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Dexcom rejects claims of unauthorized device changes in FDA warning letter
A company spokesperson said Dexcom plans to resolve the agency’s concerns but stated no design changes were made to its glucose sensors.
Madeleine DeSpirito
Mar 272 min read
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