MedTech Device News

Study Finds Sepsis Detection Tool Reduces Deaths

Bayesian Health, a machine learning startup has found in collaboration with Johns Hopkins University that a sepsis early detection tool has reduced sepsis associated deaths by approximately 18%. Sepsis is identified as a life-threatening reaction to an infection. It occurs…

Smiths Medical Recalls Infusion Pumps After Patient Death

The U.S. Food and Drug Administration has announced that Smiths Medical, a medical device manufacturer, has sent an Urgent Medical Device Correction letter to inform its customers about potential risks associated with their Syringe Infusion Pumps.The letter notified users that…

510(k) Clearance Granted To ResApp Sleep Apnea Detection App

The US Food and Drug Administration has granted clearance to ResApp Health’s 510(k) app. The SleepCheckRx app screens users for moderate to severe sleep apnea by listening to recordings of their breathing and snoring. The regulatory clearance will only apply…

Digital Health News

510(k) Clearance Granted To ResApp Sleep Apnea Detection App

The US Food and Drug Administration has granted clearance to ResApp Health’s 510(k) app. The SleepCheckRx app screens users for moderate to severe sleep apnea by listening to recordings of their breathing and snoring. The regulatory clearance will only apply…

New HHS Cybersecurity Guidelines to Protect PHI

The HHS has published new guidelines for healthcare organizations to improve the protection of the PHI they maintain. In these new guidelines, the HHS will help healthcare organizations to develop a more comprehensive cyber posture. This includes increasing the overall…

Technologies Supporting Telehealth are Placing Healthcare Data at Risk

A new Kaspersky report shows that the substantial growth in telehealth has put healthcare information in danger. Vulnerabilities were discovered in the systems that are used in telemedicine, a lot of which have yet to be resolved. Substantial Growth in…

Healthcare Vendor News

DHS Issues Cybersecurity Alert To Illumina

The Cybersecuirty and Infrastructure Agency, a component of the DHS, has issued a cybersecurity alert regarding Illumina software and its multiple vulnerabilities. The Local Run Manager program provides a complete solution for collecting samples for a run, selecting run parameters,…

Log4j Version Three to Solve High Severity DoS Vulnerability

The original vulnerability determined in Log4j (CVE-2021-44228) that stunned the world thanks to its seriousness, ease of exploitation, and the magnitude of its effect on the software programs and cloud solutions, is not the only vulnerability present in the Java-based…

Medtronic MiniMed Remote Controllers Recalled Due to Major Cybersecurity Issue

The Food and Drug Administration (FDA) has given a notification to end-users of Medtronic wireless insulin pumps concerning a critical security vulnerability impacting a number of remote controllers. MiniMed insulin pumps are employed to deliver insulin to help control diabetes.…

Healthcare Regulation News

510(k) Clearance Granted To ResApp Sleep Apnea Detection App

The US Food and Drug Administration has granted clearance to ResApp Health’s 510(k) app. The SleepCheckRx app screens users for moderate to severe sleep apnea by listening to recordings of their breathing and snoring. The regulatory clearance will only apply…

DHS Issues Cybersecurity Alert To Illumina

The Cybersecuirty and Infrastructure Agency, a component of the DHS, has issued a cybersecurity alert regarding Illumina software and its multiple vulnerabilities. The Local Run Manager program provides a complete solution for collecting samples for a run, selecting run parameters,…

Canada Strengthening Privacy Legislation with New Laws

The Canadian federal government is seeking to strengthen their privacy legislation with the introduction of new laws to the House of Commons. The developments to privacy law were introduced in the form of Bill C-27, a renovation of the previously…

Healthcare Cybersecurity News

CBHA Suffers Major Data Breach From Ransomware Attack

A major behavioral health alliance has recently announced a significant breach of data. The Carolina Behavioral Health Alliance (CBHA) operates in the city of Winston-Salem and is the administer of behavioral health benefits for Wake Forest University and Wake Forest…

Concerns Raised Over FDA Cybersecurity Draft Guidance

In April 2022, the FDA published a draft guidance concerning cybersecurity medical devices. The Agency sought to help medical device manufacturers with integrating cybersecurity practices into their products in the premarket period and to help ensure security risks were addressed…

Uncategorized

Northwestern University Develops Alternative To Drugs For Pain Relief

Northwestern University has recently published a study that details a new device which may present an alternative to opioids for pain relief. The study, reported June 30th, details a new device that is implanted near a patient’s nerves. The device…

FDA Approves Google’s Atrial Fibrillation Detection Device

The Food and Drug Administration has awarded 501k clearance to Verily and iRhythm Technologies for the new cardiac arrhythmia feature on their Zio Watch. The approval comes as wearables continue to become an integral part of healthcare treatment. Wearables can…

MedTronic Awarded FDA Approval For Spine Surgey Planning Platform

Medtronic has recently announced that their spine analyzing planning platform has received FDA 501k clearance. The healthcare technology global leader reported the news on July 14 2022. The UNiD Spine Analyzer v4.0 planning platform includes an artificial intelligence powered algorithm…