Medtronic Wins FDA Panel Backing to Allow Defibrillators for More Patients
Medtronic Inc. (MDT), the world’s biggest maker of heart-rhythm devices, won the backing of an advisory panel to expand the use of defibrillators that synchronize the right and left chambers of the heart. http://www.bloomberg.com/news/2011-12-07/medtronic-wins-fda-panel-backing-to-allow-defibrillators-for-more-patients.html
Draft Guidance – In Vitro Companion Diagnostic Devices
This guidance is intended to assist (1) sponsors who are planning to develop a therapeutic product1 that depends on the use of an in vitro companion diagnostic device (or test) for its safe and effective use and (2) sponsors planning to develop an in vitro companion diagnostic device that is intended to be used with a corresponding therapeutic product. http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm262292.htm
Former Synthes, Norian execs receive prison terms
New Stent Type Has Rare But Potentially Serious Problem, FDA Investigates
The FDA says it is working with drug-eluting stent makers to better understand what makes the devices shrink or become deformed on rare occasions. A drug-eluting stent is a scaffold placed into narrowed, diseased peripheral or coronary arteries; it releases a medication to block cell proliferation, which helps prevent eventual reclogging of the blood vessel. The DES (drug-eluting stent) is placed during an angioplasty procedure.
http://www.medicalnewstoday.com/articles/237999.php
National electronic health records network gets closer
NEW YORK (CNNMoney) — The ambitious goal of setting up a nationwide, interconnected, private and secure electronic health records system isn’t yet a reality — but we’re getting closer. http://money.cnn.com/2011/11/18/technology/electronic_health_records/index.htm?section=money_news_economy
Neurostimulator Okayed for Chronic Pain
The FDA has approved a Medtronic neurostimulation system for treating chronic back and leg pain that incorporates motion-sensor technology that adjusts the timing and level of stimulation according to patients’ body movements, the company said. http://www.medpagetoday.com/PainManagement/PainManagement/29800
Angel Investment In Small Business Is Up
Good news about small business financing is rare these days, but a new report on angel investing offers a bright spot in the clouds: Angel investment in small businesses is on the upswing, according to Q1 Q2 2011 Angel Market Trends. http://www.networksolutions.com/smallbusiness/2011/11/angel-investment-in-small-business-is-up/
SOP: Decision Authority for Additional or Changed Data Needs for Premarket Submissions
The purpose of this document is to define the appropriate decision level for making additions or changes in data requirements from what was requested for premarket submissions in previous communications. http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm279288.htm
Pilot Program for Early Feasibility
The Food and Drug Administration (FDA) is soliciting nominations from sponsors of innovative device technologies to participate in a pilot program for early feasibility study investigational device exemption (IDE) applications. http://www.gpo.gov/fdsys/pkg/FR-2011-11-10/pdf/2011-29116.pdf
Draft Guidance – FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations
FDA seeks to encourage medical device research and innovation to address important clinical needs and improve patient care. In many cases, device development and evaluation includes clinical investigation. This guidance document has been developed to promote the initiation of clinical investigations to evaluate medical devices under FDA’s Investigational Device Exemptions (IDE) regulations, Title 21 Code of Federal Regulations (CFR) Part 812. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm277669.htm
