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Diagnostics & Healthcare News

MedicaSafe Announces Partnership with Amneal Pharmaceuticals to Create Locked Medication Cartridges

MedicaSafe, Inc. announced a partnership with Amneal Pharmaceuticals, Inc. to provide Amneal’s generic version of Suboxone® (buprenorphine and naloxone) as part of MedicaSafe’s data-generating medication system. This partnership provides a system aimed to deliver real-time information about the patient’s medication access pattern,...

October 8, 2019

Diagnostics & Healthcare News

Prototype Smartphone App can Help Parents Detect Early Signs of Eye Disorders in Children

A Baylor University researcher’s prototype smartphone app — designed to help parents detect early signs of various eye diseases in their children such as retinoblastoma, an aggressive pediatric eye cancer — has passed its first big test. The CRADLE app...

October 7, 2019

Diagnostics & Healthcare News

Biodesix Secures U.S. Patent for Proprietary Blood Specimen Collection Device 

Biodesix, Inc., announced it has been issued U.S. Patent Number 10,422,729, which covers the Biodesix Collection Device (BCD). The new device offers improved ease of use in blood sample collection for diagnostic testing, compared to current standard methods. “This device...

October 3, 2019

Diagnostics & Healthcare News

Cellular-connected Drones to Deliver Life-saving Emergency Defibrillators Following Ground-breaking Canadian Trial 

A ground-breaking trial using 4G LTE cellular connectivity to enable beyond-visual-line-of-sight (BVLOS) drones to deliver automated external defibrillators (AEDs) to the scene of a cardiac arrest has taken place in the County of Renfrew, Ontario, Canada. Working in partnership with technology providers, including...

October 2, 2019

Diagnostics & Healthcare News

FDA Continues to Take Steps to Fulfill its Commitment to Strengthen and Modernize the 510(k) Medical Device Program 

The U.S. Food and Drug Administration today announced that, as a first step toward implementation of the recently established Safety and Performance Based Pathway for medical devices, the agency is issuing draft guidances outlining the recommended premarket performance criteria and testing methodologies...

September 25, 2019

Diagnostics & Healthcare News

Minimally Invasive Biopsies Provide Maximum Pathology Data

Current pathology techniques for analyzing biopsy tissues are lacking in their ability to detect cancer in small samples. Being able to rapidly study the distribution of protein expression within cells, gathered from minuscule samples, could be an important tool for...

September 19, 2019

Diagnostics & Healthcare News

FDA Clarifies Refuse-to-Accept Policy for 510(k) Applications 

The FDA has updated its final guidance on its “refuse-to-accept” policy for 510(k) submissions. The guidance includes detailed checklists for devices that applicants want to be considered for traditional, abbreviated or special 510(k) clearance. The agency said it will respond to applications...

September 16, 2019

Diagnostics & Healthcare News

Ultrasound Sensor Aids Diagnosis of Middle-ear Infection

A new type of ultrasound transducer from Fraunhofer should soon be delivering a fast and reliable diagnosis of infection of the middle ear. A U.S. company and the Fraunhofer Institute for Photonic Microsystems IPMS are collaborating on the development and...

September 16, 2019

Diagnostics & Healthcare News

Cochlear and GN Hearing Become World’s First to Support Direct Android Streaming to Hearing Devices Using Bluetooth Low Energy 

Collaboration with Google on hearing aid specification now officially brings direct streaming of music, phone calls and other sound to people with hearing loss. For the first time, people can stream sound from their compatible Android devices to their hearing...

September 12, 2019