Artivion Inc. (formerly Cryolife Inc.) received U.S. FDA premarket application (PMA) approval of its Perclot absorbable hemostatic system and promptly sold the product line to Baxter International Inc., in keeping with the terms of an agreement announced in July 2021. Artivion will begin shipping Perclot product to Baxter following receipt of a milestone payment of $18.75 million in cash, of which $4.5 million will go to Artivion’s former partner Starch Medical Inc. Read More
Bringing both ventricles back into synchrony has long been the subject of cardiological hopes in patients with heart failure, but current approaches to maximizing the function of the left ventricle leave many patients in a desperate state of cardiac dyssynchrony. However, Ebr Systems Inc., has reported the results of a study that demonstrates that its WiSE device can pace the left ventricle in patients who are unresponsive to conventional pacing in an effort to restore optimal left ventricular function, a development Sunnyvale, Calif.-based Ebr says will allow the company to conclude a premarket filing with the U.S. FDA. Read More
Jewelry used to adorn the human ear is not the stuff of legend where medical technology is concerned, but a clip-type device, similar to an earring, that can be worn on the tragus of the ear might soon become daily wear for those who suffer from postural orthostatic tachycardia syndrome (POTS). Researchers at the University of Oklahoma say their self-administered clip can relieve POTS with just one hour’s use per day over a period of two months, a finding that might prove an inexpensive and convenient treatment for as many as one million Americans who currently have few treatment options. Read More
Results from a new study suggest that treatment with Magnus Medical Inc.'s Saint neuromodulation system causes abnormal brain signals to become normal by reversing the direction brain signals flow in severely depressed individuals. The researchers also identified a new biomarker that could help doctors diagnose and treat major depressive disorder (MDD). Read More
Although digital health technologies are being developed at breakneck speed, policies to reimburse these new technologies are lacking and are desperately needed if Australia is to be competitive in the digital health space, said speakers during the Andhealth Digital Health Summit in Adelaide on May 23. Read More
The French National Authority for Health, known in France as the Haute Autorité de la Santé (HAS), recently published a favorable opinion regarding reimbursement for the first diagnostic test to benefit under an innovation initiative. The test is the Metaglut1 test from Metafora Biosystems SAS, a non-invasive diagnostic test that identifies glucose transporter type 1 deficiency syndrome (Glut1DS). Read More
New hires and promotions in the med-tech industry, including: Cepheid, Harbinger Health, Impact Vitals, Perimeter Medical Imaging AI, Talis Biomedical. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Anuncia Medical, Cytovale, Moleculight; Moximed. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: AIVF, Alivecor, Cybeats, Doccla, Fresenius, Genea Biomedx, Guardant, Hardy Diagnostics, Starfish Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Artivion. Read More
