by RB | Feb 18, 2022 | Regulatory
It is important to note that the US FDA is undergoing a major change that will affect the entire US regulatory process. Called “Case for Quality” or CFQ. To understand CFQ, it is best to first understand the current process. The FDA “510K”...
by Alice Ferng | Feb 15, 2022 | Exclusive, OTC, Psychiatry
A quick way to soothe your nerves sounds too good to be true. There are many methods and techniques used for achieving this “calm” that include breath work, visualization, meditation, and other individualized activities. However, what intrigued us was that there is a...
by Alice Ferng | Feb 14, 2022 | Cardiology, Exclusive, kardia, OTC
A couple of weeks ago, AliveCor, a leading innovator in the FDA-cleared personal electrocardiogram (ECG) technology space, announced the launch of the KardiaMobile Card. The KardiaMobile Card is the slimmest and smallest self-contained, commercially available ECG that...
by RB | Jan 3, 2022 | Clinical Technology, QRS Prolongation
This is a recent post I wrote in the Dassault Systemes Medidata community over the holidays regarding a marketing plan focused on QRS prolongation: Note that most of the article links will not work as they are referencing items behind a VPN firewall…...
by RB | Dec 25, 2021 | Clinical Technology
Dr. Richard Crane created a disruptive technology when he created a patient monitoring data-sharing protocol that used UDP as a packet broadcast methodology to send data from a patient monitor out onto the network where it could be received by a central station. This...
by Conn Hastings | Dec 15, 2021 | Materials, Sports Medicine, ubc
Engineers at the University of British Columbia created a flexible waterproof battery that is durable enough to undergo multiple wash cycles. The battery is so pliant that it can still function when stretched to double its original length. It’s made of low-cost...
by RB | Oct 21, 2021 | AED, Clinical Technology
[From RFID Journal] BY CLAIRE SWEDBERG HeartHero’s mobile automated external defibrillator, which comes with NB-IoT, GPS and Bluetooth Low Energy, provides emergency responders with alerts and location information as soon as someone opens the device and places...
by Conn Hastings | Sep 10, 2021 | Dentistry, Materials
Researchers at the University of Pennsylvania created a dental implant that resists bacterial growth and generates electricity thanks to its piezoelectric properties. The generated electricity could power a light source for on-board phototherapy, a technique that...
by Conn Hastings | Sep 9, 2021 | Critical Care, Exclusive, Medicine, Surgery, Thoracic Surgery
Boston Scientific recently announced FDA clearance of the EXALT Model B single-use bronchoscope, intended for bedside procedures in intensive care units or in the operating room. As a single-use device that boasts high quality imaging and suction capabilities, the...
by Conn Hastings | Sep 2, 2021 | clevelandclinic, Prosthetics, Rehab
Researchers at the Cleveland Clinic have developed an advanced bionic arm that allows users with upper limb amputations to achieve a similar level of function as non-amputees. The system incorporates a sense of touch and movement and allows for intuitive motor...
