Value-based care: CMS’s new administrator wants more of it

Seven months into her tenure, CMS administrator Seema Verma is turning out to be highly supportive of value-based care models. In fact, she recently told an audience in Cleveland that she wants them implemented faster. The situation appears to dispel doubts that alternative payment models – such as Accountable Care Organizations or “comprehensive care” models for

FDA’s role in medical device cybersecurity

Dr. Suzanne Schwartz, FDA Virtually every aspect of our lives – including our health – has gone digital. Medical devices from insulin pumps to implantable cardiac pacemakers are becoming more interconnected and, like computers and the networks they operate in can be vulnerable to security breaches. A computer virus or hack resulting in the loss of

7 medtech stories we missed this week: Nov. 3, 2017

From Hologic’s new product launch to CapsoVision gettting CE Mark approval, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Hologic launches new MyoSure device Hologic announced in a Nov. 1 press release that it has launched its MyoSure Manual Device in the U.S. The device is designed

OCTANe: Southern California leads in medtech jobs and job creation

Southern California in recent years provided the highest level of employment to medtech, according to U.S. Dept. of Commerce data compiled by OCTANe. Bill Carpou, OCTANe’s president and CEO, presented the statistics during his welcome address at the Medical Technology Innovation Forum (MTIF) earlier this week. The area including Los Angeles, Orange County, and San Diego employed

FDA issues final guidance on medical device changes that need new 510(k) submissions

By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration have published final guidance explaining when changes to registered devices warrant filing new 510(k) premarket notifications to the agency. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only

Medtronic’s CEO thinks value-based care is really important: Here’s why

Value-based care is the future of healthcare, and according to CEO Omar Ishrak, it is the past, present and future of Medtronic. Ishrak spoke at OCTANe’s Medical Technology Innovation Forum (MTIF) this week about the opportunity and responsibility medical device companies have when it comes to adopting value-based care models.  In this future, Ishrak sees

The Mammography Quality Standards Act: A 25-year public health success story

By: Dr. Helen Barr Mammography has been widely used as a screening tool to detect early-stage breast cancer since the mid-1960s. As the use of the technology expanded it became clear that there were wide variations in the quality of the mammograms and the dose being delivered to patients. Following a series of hearings, Congress stepped

Nelson Labs parent Sterigenics buys Toxikon’s European lab business

Sterigentics International is seeking to turn its Nelson Labs business into a global extractables and leachables lab testing platform through its acquisition of Toxikon’s European division. The purchase of Toxikon Europe, announced yesterday, represents a capabilities expansion when it comes to serving the pharmaceutical and medical device industries. Sterigenics’s Nelson Labs business will now offer Toxikon

Philips unveils new image-guided therapies and diagnostic devices

Philips is showcasing some of its recently expanded image-guided therapies at the annual Transcatheter Cardiovascular Therapeutics (TCT) event in Denver this year. The company is touting its advanced interventional imaging systems, diagnostic and therapeutic devices, planning and navigation software and various services. It is also showcasing its latest cardiac care solutions for ultrasound and image-guided

Europe’s new plan to address orphaned medical device manufacturers

By Annette van Raamsdonk, Emergo Group European Member States are implementing a procedure for manufacturers that no longer have a Notified Body (NB) due to scope reduction or de-notification. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect

Validation and testing: What you need to know

James Woods, Jordi Labs In an increasingly competitive medical device industry, it’s still important that validation and testing is done right. Here are four things to keep in mind. Medical device industry leaders these days are driving results at an ever-increasing pace. Amid patent limitations, intense competition and acute regulatory scrutiny, there’s a rush to

FDA launches new market pathway for breakthrough medical devices

By Stewart Eisenhart, Emergo Group The US Food and Drug Administration plans to establish a new market authorization pathway for innovative and breakthrough medical devices that would replace current priority review programs including the Expedited Access Pathway (EAP) and the Priority Review Program. Get the full story here at the Emergo Group’s blog. The opinions

Why a global footprint is a medtech business imperative, not a buzzword

Oscar Ford, Preh IMA Automation A global manufacturing footprint can help medical device companies capture value for their businesses by accessing talent and reducing costs. Here’s how to successfully execute this strategy without falling into a reactionary offshore initiative. In the last two decades there was an undeniable shift in the U.S. toward offshoring manufacturing

Medtech stories we missed this week: Oct. 27, 2017

From RadiaDyne’s FDA expansion to NuVasive launching its new implants, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA expands indications for RadiaDyne’s OARtrac dose monitor RadiaDyne announced in an Oct. 24 press release that it has received additional FDA clearance for its upcoming OARtrac. The OARtrac allows

Integer posts street-beating Q3

Integer today posted third quarter earnings that beat expectations on Wall Street. The Frisco, Texas-based company posted profits of $13.7 million, of 43¢ per share, on sales of $363.3 million for the 3 months ended September 29, seeing bottom-line growth of 19.5% while sales grew 4.8% compared to the same period last year. Adjusted to