Approvals

FDA Clears Perspectum Diagnostics Liver Scanning Device

The FDA granted marketing clearance to Perspectum Diagnostics’ LiverMultiScan a post-processing software device for magnetic resonance imaging of the liver, delivered through a cloud-based service.

The liver characterization procedure is non-invasive and does not require contrast agents. The clearance means the technology can now be used on a wider range of scanners, including compatible Siemens and Philips MR systems.

The device is CE marked in Europe.

Aidoc Gets CE Mark for Deep Learning Imaging Solution

Artificial intelligence startup Aidoc earned a CE Mark for its head and neck deep learning medical imaging solution.

The device is designed to improve radiologists’ workflows by detecting abnormalities in imaging to aid in more timely diagnoses. The technology allows radiologists to prioritize cases based on AI medical image analysis in conjunction with other clinically available data.

Cagent Vascular Receives CE Mark for Vessel Dilatation Device

Cagent Vascular earned a CE Mark for its Serranator PTA serration balloon catheter.

The product features four serrated metal strips that help improve arterial expansion.

The Serranator “capitalizes on the simplicity and familiarity of angioplasty while introducing a new and more effective method of vessel expansion,” said Cagent’s co-founder and chief medical officer, Peter Schneider.

Cagent received FDA Clearance for its first product, Serranator Alto, early this year.

Cerebrotech Wins CE Mark for Intracranial Fluids Monitor

California-based Cerebrotech Medical Systems has received CE Mark for its Intracranial Fluids Monitor powered by proprietary machine learning and artificial intelligence software.

The non-invasive bioimpedance spectroscopy device is designed for detecting changes in and the distribution of brain fluids to identify signals associated with stroke in less than one minute. The company has plans to also train the device’s software to detect a range of health-related complications, including traumatic brain injury and brain tumors.

South Africa Approves United Health Products’ HemoStyp Device

United Health Products received regulatory approval to market its patented hemostatic gauze in South Africa.

HemoStyp is indicated for treating wounds that have breached the skin’s dermis, including chronic extensive ulcerated wounds and severe burns, the company said.

Omega Diagnostics HIV Test Scores CE Mark

UK-based Omega Diagnostics Group earned a CE Mark for its VISITECT CD4 HIV test.

The disposable test is designed to determine immune status of patients diagnosed with the HIV infection with whole blood samples.

An optional reader is available for clinics and laboratories requiring full traceability, positive patient ID and storage of patient results.

The company said it will seek additional regulatory approval through the World Health Organization Prequalification Programme.

AliveCor Receives FDA Clearance for First Apple Watch Medical Device Accessory

The FDA cleared the first medical device accessory for the Apple Watch, manufactured by California-based developer of personal electrocardiogram (EKG) technology AliveCor.

KardiaBand can record an EKG in 30 seconds and detect normal sinus heart rhythms as well as atrial fibrillation, the most common heart arrhythmia.

The product requires a subscription from AliveCor for use with the Apple Watch. The app features the company’s SmartRhythm, which can continuously monitor the correlation between users’ heart and physical activity, to notify them when an EKG should be captured.

FDA Approves NGS-based IVD Test With Breakthrough Designation

The FDA approved the first next generation sequencing (NGS)-based in vitro diagnostic test with breakthrough designation, FoundationOne CDx (F1CDx).

The IVD test from Roche’s Foundation Medicine is the second to be approved under the FDA/CMS Parallel Review Program, in which the FDA collaborates with the Centers for Medicare and Medicaid Services to expedite the review process, so Medicare beneficiaries have earlier access to innovative medical technologies.

The F1CDx can detect mutations in 324 genes and two genomic signatures by sequencing DNA.