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Connected medical devices are transforming healthcare and clinical trials, driving advances in patient care and next-gen therapies shaping the future.
By Jennifer D. Newberger —
By Adrienne R. Lenz, Principal Medical Device Regulation Expert —
The Centers for Medicare & Medicaid Services and the Food and Drug Administration April 23 announced a new pathway to expedite access to certain FDA-designated Class II and...
The EU Commission published its 170-page proposal on revisions of the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) on D...
Key Takeaways: Faster Medicare Coverage. The Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) have announced the Regulatory Alig...
To evaluate novel sensorized ‘smart’ instruments that generate real-time imaging, localization, temperature, and pressure data directly at the instrument tip, enabling visualizatio...
David Ferrera is a medical device engineer, entrepreneur, and inventor with nearly 30 years of experience in neurovascular and interventional medicine. Read more: David Ferrera on...
WASHINGTON, April 14, 2026 /PRNewswire/ -- Today, Antonio Ortiz-Mena, CEO of AOM Advisors, and Christopher G. Sheeron, CEO of Action for Health, released "Critical Care: Protecting...
Wearable devices are products worn on the body that use sensors and software to collect and display health or lifestyle information such as activity, sleep, or recovery trends. Wh...
On April 23, 2026, the Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) jointly announced the Regulatory Alignment for Predictable and Imme...
Protaryx Medical, a Maryland-based company dedicated to “minimally invasive left-heart interventional therapies,” announced that its Transseptal Puncture Device received 510(k) cle...
FRIDAY, April 24, 2026 — A new proposal could make it easier for patients to access breakthrough medical devices through Medicare. On Thursday, federal regulators announced a plan...
KUALA LUMPUR, April 20 — The supply of medical devices in Malaysia remains stable and under control despite the gl...
On April 23, 2026, the Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) jointly announced the Regulatory Alignment for Predictable...
NEW ORLEANS — Use of a sensor-enabled smart device implanted at the time of total knee arthroplasty may detect periprosthetic joint infection before diagnosis, according to results...
The Food and Drug Administration has identified a nationwide recall. Arrow International is recommending dialysis catheter kits containing Merit Medical 16F Dual-Valved Splittable...
VElectrical safety class, EMC characterization, sensor architecture, and OEM compliance documentation are the variables that determine whether a medical device camera integration c...
- Presented key product lines spanning aesthetic, wound care, bone and spine, and surgical fields
Medtronic’s Adaptive Deep Brain Stimulation (aDBS) system uses BrainSense technology, approved by the US Food and Drug Administration
Brazil’s regulator Anvisa has suspended selected medical devices after identifying packaging defects that could compromise sterility and patient safety. The post Brazil regulator s...
The Food and Drug Administration has issued a Class I recall correction for certain Boston Scientific ACCOLADE pacemakers and cardiac resynchronization therapy pacemakers after ide...
MIT researchers have developed soft, stretchable transistor architectures that amplify weak biological signals while conforming to human tissue, paving the way for advanced wearabl...
What You Should Know ECRI, a nonprofit patient safety organization, submitted formal recommendations to the House Energy and Commerce Subcommittee on Health in April 2026. The orga...
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