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Medical Devices


Dexcom nets FDA clearance for 15-day CGM
Healthcare professionals reviewing protocols, reflecting the FDA's commitment to safety and collaboration in medical advancements.
Madeleine DeSpirito
Apr 13, 20251 min read


Intuitive wins FDA clearance for single-port robotic surgery stapler
A gloved hand holds a syringe filled with yellow liquid, injecting it into a red apple alongside two other syringes containing different...
Madeleine DeSpirito
Apr 13, 20251 min read


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 13, 20251 min read


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 13, 20252 min read


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 6, 20254 min read


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 6, 20254 min read


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 2, 20252 min read


Boston Scientific’s Farapulse matches Medtronic cryoablation in trial
Atrial tachyarrhythmia recurred in 39 patients treated with Boston Scientific’s Farapulse PFA device,.
Madeleine DeSpirito
Apr 2, 20252 min read


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 2, 20253 min read


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 27, 20252 min read


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 27, 20254 min read


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 27, 20252 min read
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