Medicare chief next at bat for healthcare overhaul. Centers for Medicare and Medicaid administrator Donald Berwick will make his first appearance before Congress next week. Though the GOP majority hasn’t yet desended on the hill after the party’s midterm victories, he’s likely to have lots of questions to answer about President Barack Obama’s healthcare reform legislation, Bloomberg reports.
Minnesota healthcare group signs Nuance for statewide program
Nuance Communications Inc. (NSDQ:NUAN) signed a deal with the nonprofit Institute for Clinical Systems Improvement for the company’s decision support system.
MassDevice On Call: Medicare’s universal coverage experiment failure
Life-saving care at great cost. How did our nation’s most ambitious experiment in universal healthcare — comprehensive Medicare coverage for every kidney failure patient — descend from a “supremely hopeful moment” nearly four decades ago to a $20-billion-a-year “hulking monster” that kills thousands of patients? ProPublica tries to answer those questions in its latest investigative series.
The MassDevice Weekly Checkup: November 9, 2010
Our Weekly Checkup takes the temperature of the medical device industry’s three largest U.S. clusters: Massachusetts, California and Minnesota.
The MassDevice Indices are weighted according to market capitalization, based on the number of shares outstanding for each company and each Friday’s closing share price.
The Massachusetts index for the week ended Nov. 5 closed at 5.77, up 4.9 percent compared with the prior week. Since Jan. 1, 2009, when we began tracking these companies, the index has risen 30.1 percent.
Intertek Offers New Training Course on the Safety and Risk Management Requirements of IEC 60601-1, 3rd Edition
Intertek, a leading global provider of quality and safety solutions, announces a new two-day seminar for medical device manufacturers. The seminar, titled “Safety and Risk Management Requirements of IEC 60601-1, 3rd Edition,” will be held on December 1st and 2nd in Boxborough, MA.
Compliance with the 3rd Edition of IEC 60601-1 will become mandatory for medical devices in 2012. New requirements for Risk Management necessitate manufactures to consider the development of their Risk Management File early in the product development cycle.
Intertek’s new training course will help manufacturers interpret the revised IEC 60601-1 3rd Edition standard – particularly the new Risk Management aspects of the regulations – and understand what actions need to taken to ensure compliance.
The MassDevice Weekly Checkup: November 2, 2010
Our Weekly Checkup takes the temperature of the medical device industry’s three largest U.S. clusters: Massachusetts, California and Minnesota.
The MassDevice Indices are weighted according to market capitalization, based on the number of shares outstanding for each company and each Friday’s closing share price.
The Massachusetts index for the week Oct. 29 closed at 5.49, down 3.3 percent compared with the prior week. Since Jan. 1, 2009, when we began tracking these companies, the index has risen 24.0 percent.
Bigger Isn’t Always Better For Notified Bodies
Industry Consolidation Puts Focus on Service
Recent mergers and acquisitions in Europe have many predicting the days are numbered for small Notified Bodies. If you add in the increased level of oversight and regulation being introduced by the Competent Authorities, this prediction is probably not too far off. But this era of transition also has its opportunities.
The MassDevice Weekly Checkup: October 26, 2010
Our Weekly Checkup takes the temperature of the medical device industry’s three largest U.S. clusters: Massachusetts, California and Minnesota.
The MassDevice Indices are weighted according to market capitalization, based on the number of shares outstanding for each company and each Friday’s closing share price.
The Massachusetts index for the week ended Oct. 22 closed at 5.57, up 2.5 percent compared with the prior week. Since Jan. 1, 2009, when we began tracking these companies, the index has risen 25.7 percent.
Is your MOA video DOA?
I’ve recently become a huge fan of the medical drama House. If you’ve never seen this long-running Fox show starring Hugh Laurie as Dr. Gregory House, turn it on — the reruns are everywhere. He’s a brilliant, curmudgeonly doctor who leads a team of diagnosticians. In one memorable episode, House is trying to save the life of a renowned physician who insists he’s got tuberculosis—and nothing else. But numerous treatments fail to work, and time is running out.
The MassDevice Weekly Checkup: October 19, 2010
Our Weekly Checkup takes the temperature of the medical device industry’s three largest U.S. clusters: Massachusetts, California and Minnesota.
The MassDevice Indices are weighted according to market capitalization, based on the number of shares outstanding for each company and each Friday’s closing share price.
The Massachusetts index for the week ended Oct. 15 closed at 5.57, up 2.5 percent compared with the prior week. Since Jan. 1, 2009, when we began tracking these companies, the index has risen 25.7 percent.
Asian Regulatory Experts to Attend the RAPS Annual Conference & Exhibition
BETHESDA, Md., October 20, 2010 – Pacific Bridge Medical will be attending the RAPS Annual Conference & Exhibition from October 24-27, 2010, at the San Jose McEnery Convention Center, San Jose, CA.
RAPS Annual Conference & Exhibition provides a forum for professionals working within regulatory and related areas of the pharmaceutical and medical device sector to expand their breadth of knowledge and networks. This event is designed to help the regulatory community succeed in the global regulatory landscape.