This article was originally published in The Gray Sheet
Second-generation dual chamber pacemaker, the META DDDR 1254, receives FDA go-ahead to begin marketing. The device is smaller than the first generation META DDDR 1250H and has "several significant enhancements designed to improve function and ease of use," the company claims. Indications for use also are expanded to "patients with occasional atrial arrhythmias." A premarket approval application for the 1250H was approved in February 1992 ("The Gray Sheet" Feb. 10, 1992, p. 7).
You may also be interested in...
Orladeyo is the first oral prophylactic approved in the US for hereditary angioedema, with Japan and EU approvals expected to follow. Pricing of $485,000 a year undercuts segment leader.
Results of Study to Assess Statin Residual Risk with Epanova in High Cardiovascular Risk Patients with Hypertriglyceridemia “should prompt reconsideration of [OTC] mixed omega-3 fatty acid products for [atherosclerotic cardiovascular disease] prevention,” say cardiologists in an editorial published with JAMA study.
In a final guidance from the US agency, regulators say most combination product questions are best resolved through traditional pathways and noted that initiating a so-called combination product agreement meeting may be unproductive.