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Home » Topics » Medical Devices » Submissions and Approvals

Submissions and Approvals
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Transit Scientific Receives CE Mark for Microcatheter Platform

March 18, 2021
It is made of nontapered metal-alloy and polymer that helps it better handle tough calcium and plaque found in late-stage peripheral artery disease and critical limb ischemia patients. Read More

FDA Declining to Assess Some Emergency Use Authorization Requests

March 18, 2021
There are so many COVID-19 tests on the market that one of the conditions for granting an Emergency Use Authorization — that there are no such products available — no longer applies. Read More

Imbio Earns 510(k) Clearance for Ventricular Dilation Algorithm

March 17, 2021
The algorithm’s results are added to the patient’s imaging study in minutes. Read More

Pelican Diagnostics Receives CE Mark for COVID-19 Saliva Test

March 16, 2021
Pelican said that the test has high sensitivity in both symptomatic and asymptomatic patients and is able to detect known new viral variants as well. Read More
CE mark

Fujifilm Earns CE Mark for Rapid COVID-19 Test

March 16, 2021
The company said that the test can successfully detect presence of the virus even in patients who exhibit low viral load at disease onset. Read More
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Baxter Earns FDA Clearance for Hemodialysis System

March 15, 2021
The system features a customizable, app-like user interface that simplifies prescription management and treatment supervision. Read More
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SD Biosensor’s COVID-19 Antigen Rapid Test Gets Health Canada OK

March 15, 2021
The test kit was the first rapid antigen test approved for emergency use by the World Health Organization. Read More
CE mark

Shape Memory Obtains CE Mark for Embolization Plug System

March 12, 2021
The RapidFill system uses the company’s Shape Memory Polymer technology, a porous scaffold that is crimped for catheter delivery and expands upon contact with blood to rapidly clot it. Read More
FDA clears text

Zymo Research’s COVID-19 Sample Collection Device Cleared by FDA

March 12, 2021
The viral RNA placed in the device is stabilized at an ambient temperature for up to 28 days for evaluation by reverse transcription polymerase chain reaction (RT-PCR). Read More

Brain Scientific Gets 510(k) Clearance for New Generation of NeuroCap

March 11, 2021
The latest version features velcro strips for improved adhesion and a new extra small size. Read More

Datar Cancer Genetics Gains CE Mark for Cancer Diagnostic

March 11, 2021
The blood test can help individuals with suspicious growths in the lung, breast, prostate, brain or colon to avoid invasive biopsies. Read More
FDA clears text

Cuptimize’s Hip Surgery Software Cleared by FDA

March 11, 2021
It is designed to help hip surgeons understand when patients have a problem with pelvic tilt, determine cup placement to mitigate risk and clearly indicate when to use dual mobility implants, the company said. Read More
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