1. DePuy Synthes launches spinal implants
DePuy Synthes announced in an April 26 press release that it has launched its Proti 360º integrated titanium family of interbody devices that are designed to be used with patients who have degenerative disc disease in their neck and back. The Proti 360º is designed to maximize the potential for bone growth while offering the benefits of PEEK and titanium. Titanium creates a bioactive surface that promotes attachment and bone-forming cell growth.
2. PavMed to commercialize EsoCheck Barrett’s Esopagus biomarker test
PavMed has signed a letter of intent with Case Western Reserve University to commercialize its EsoCheck technology, according to an April 24 press release. EsoCheck is a non-invasive, cell-sampling device that features highly accurate DNA biomarkers that detect Barrett’s Esophagus. The device is offered as an office-based test that takes five minutes to complete. A patient swallows a vitamin pill-sized capsule that has a small inflatable balloon attached to a thin catheter. The balloon swabs the target area for cells as the catheter is removed. Then the sample can be tested for DNA biomarkers.
3. Cerus wins Health Canada nod for Intercept blood system
Cerus announced in an April 25 press release that it has won Health Canada approval to commercialize its Intercept Blood System for platelets. The system is designed for ex vivo treatment and storage of platelet components. It is used to inactivate a broad range of pathogens like viruses, bacteria and protozoan parasites to reduce the risk of transfusion-transmitted infections.
4. ReShape Lifesciences enters Bahrain
ReShape Lifesciences has received registration from the National Health Regulation Authority in Bahrain to market and distribute its ReShape Balloon, according to an April 24 press release. Yousuf Mahmood Husain, one of Bahrain’s largest healthcare companies, will be the distributor of the ReShape Balloon. The device involves a non-surgical weight loss procedure that uses balloon technology that takes up room in the stomach to help obese patients lose weight.
5. Sanquin, Abbott ink multi-year blood tech deal
Sanquin and Abbott announced in an April 23 press release that they have signed a multi-year contract for the supply of primary serological equipment and consumables like Abbott’s Alinity system for blood and plasma screening. The companies already have a relationship of more than 10 years.
6. Apollo Endosurgery wins regulatory nod in Saudi Arabia
Apollo Endosurgery has gained approval from the Saudi Food and Drug Authority in Saudi Arabia for its Orbera365 managed weight loss system, according to an April 23 press release. The SFDA also issued a Medical Device Marketing Authorization for the device which allows the company to market in Saudi Arabia with its distribution partner Al-Nozha Medical. Orbera365 doubles the indwell period of the intragastric balloon from 6 months to a 12 month treatment period. The extra six months allows for more time for better patient outcomes.
7. FDA clears Lumendi’s Dilumen C2
Lumendi announced in an April 23 press release that it has received FDA 510(k) clearance for its DiLumen C2 endoscopic accessory. The device is designed to ensure complete positioning of an endoscope in the large intestine while also assisting with optical visualization, diagnosis and endoscopic treatment. It uses two balloons to create a stabilizing therapeutic zone inside the colon during endolumenal interventions and uses two 6mm diameter tool channels to make room for two independent flexible articulating hand instruments.