Medtech & Devices

FDA grants De Novo clearance to smartphone-controlled acute migraine-relief device

Theranica, an Israel-based biomedical technology company focused on developing advanced electroceuticals for migraine and other prevalent diseases, announced on May 28 that the U.S. Food and Drug Administration (FDA) granted a De Novo request for its smartphone-controlled electroceutical, Nerivio Migra, utilising Remote Electrical Neuromodulation for the acute treatment of migraine.

[ Read More ]

70% of medical devices will be running unsupported Windows operating systems by January

The number of connected medical devices being used in hospitals and healthcare organizations continues to grow at a rapid pace, representing a vulnerable surface for cyberattacks.Raising the cyberrisks even further, 70% of devices in healthcare organizations will be running unsupported Windows operating systems by January 2020, according to a new cybersecurity report.Microsoft support for devices

[ Read More ]

Medical Claims Management Solutions Market and its Growth Prospect in the Near Future

A medical claim is a detailed invoice that a health care provider sends to the health insurer, exactly showing the services that have been rendered by the providers to the patient. Medical claims management involves multiple administrative and customer service layers that include review, investigation, adjustment, remittance or denial of a claim. Improved focus on

[ Read More ]

A machine learning device, meant for chronically ill, moves into homes

wearable device that uses machine learning to remotely track and analyze multiple vital signs has been cleared by the Food and Drug Administration, expanding the scope of home monitoring systems intended to keep chronically ill patients out of the hospital.Current Health, based in Edinburgh, Scotland, announced Wednesday it received clearance for an upper-arm wearable that

[ Read More ]

Tiered FDA medical device security guidance concerns industry

brThe U.S. Food and Drug Administration (FDA) recently released its draft guidance on managing cybersecurity in medical device premarket submissions. However, leading companies such as GE Healthcare and industry groups have voiced concerns over the tiered approach, saying this will result in confusion and potential discrepancies. They want the tiered system eliminated or amended. Industry

[ Read More ]

3 Ways to Manage the Cyber Risk Posed by Connected Medical Devices

Its not just computers or smartphones that can make your healthcare organization vulnerable to security breaches. Pacemakers, insulin pumps, wearable devices that track patient activity levels and pills containing ingestible sensors that track medication adherence are among the innovations that allow physicians to monitor patients remotely, promising more cost-effective care and improved outcomes.But connected medical

[ Read More ]