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Home » Topics » Medical Devices

Medical Devices
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NICE Lists Real-World Evidence Challenges for Devices

June 30, 2022
Real-world evidence (RWE) can be especially difficult to gather for medical devices, the UK’s National Institute for Health and Care Excellence (NICE) points out in a new “framework” document on the topic. Read More

Invictus Aura Storm Air Purifier Gets 510(k) Clearance

June 30, 2022
The FDA has granted 510(k) marketing clearance to Invictus Sterilization’s Aura Storm hospital-grade ultraviolet medical air purifier. The North Carolina-based company makes surface and air sterilization products that use ultraviolet C light. Read More

FDA Releases Guidance on ‘Fit-for-Purpose’ Clinical Outcome Assessments

June 30, 2022
The FDA emphasizes the need for high-quality approaches to developing and modifying clinical outcome assessments (COA) for clinical trials of medical devices, in a draft guidance released yesterday. Read More

Saneso’s 360-Degree Colonoscope Receives FDA Clearance

June 30, 2022
Endoscopists discovered more polyps with Saneso’s device versus traditional single-camera colonoscopes. Read More

AeroClean Granted FDA Clearance for Its Pūrgo Medical-Grade Air Hygiene Tech

June 30, 2022
The device delivers hospital-grade HEPA filtration and germicidal ultraviolet irradiation. Read More

Zavation’s eZspand Lateral Cage Cleared

June 30, 2022
The cage adjusts up to a 15-degree lordosis angle to allow for the inward curve of the lumbar spine. Read More

FDA Provides Update on GE Healthcare’s Recall of Its Carescape R860 Ventilators

June 30, 2022
If the ventilator is running on battery power only when the battery fails, ventilation could stop completely, preventing the patient from receiving oxygen and breathing support, the FDA says. Read More

MHRA Says Post-Brexit Device Regulations Will Improve Safety

June 29, 2022
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced that it is planning new device regulations aimed at improving patient safety and encouraging innovation. Read More

Philips Provides Update on Its CPAP, BiPAP and Ventilator Recall

June 29, 2022
Philips issued an update on the status of the June 14, 2021 recall of its Philips Respironics’ continuous positive airway pressure (CPAP), bi-level positive airway pressure (BiPAP) and ventilator devices, citing ozone cleaning as a possible contributor to the problem. Read More

CardieX Submits First Dual Blood Pressure and Arterial Health Monitor for FDA Clearance

June 29, 2022
Australia-based CardieX and its manufacturing partner Andon have filed a 510(k) premarket submission with the FDA for the CONNEQT Pulse, the world’s first dual blood pressure and arterial health monitor. Read More

FDA Pulls Emergency Use Authorizations for Two Quanterix COVID-19 Tests

June 29, 2022
In a June 27 notice, the agency said it had revoked emergency authorizations for both tests on May 10. Read More

Spindiag Gains CE-IVD Marks for Two Rapid PCR Tests

June 29, 2022
Spindiag also received a CE-IVD certification for its test for methicillin-resistant Staphylococcus aureus (MRSA), which causes hard-to-treat infections in humans. Read More
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