What you need to know about Europe’s new medical device rules

New regulations are coming to the European Union, and it’s up to developers to implement changes that will help them thrive in the new environment. Vicki Anastasi, Icon The new European Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) represent one of the most wide-ranging and disruptive changes to recently

Siemens Healthineers launches Share360 clinical engineering support platform

Siemens (NYSE:SI) Healthineers said today it launched the Share360 in-house service portfolio designed to support clinical engineering departments with customizable levels of support. The newly launched Share360 portfolio is intended to support customer service strategies by letting users customize the level of collaboration with Siemens they need, as well as optimizing workforce utilization, the company said. “With the […]

Pros and cons of MDNR and MDMA medical device registration in Saudi Arabia

By Stewart Eisenhart, Emergo Group Now that Saudi Arabian medical device regulators have exempted some low-risk products from full registration requirements, qualifying manufacturers should consider whether standard or fast-track access to the Saudi market best suits their business needs. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog

FDA puts Second Sight Medical’s next-gen Orion ‘bionic eye’ on the fast track

Second Sight Medical (NSDQ:EYES) said today that the FDA put its Orion “bionic eye” on the fast track to approval. The Orion device is a cortical visual prosthesis that uses a camera and a brain implant to bypass the optic nerve in visually impaired patients. The federal safety watchdog put the device on its expedited […]

Intuitive Surgical opens Korean innovation, training center

Robotic surgical giant Intuitive Surgical (NSDQ:ISRG) opened the doors this week on a new $8.9 million surgical innovation training center on South Korea, according to a Korea Herald report. The new 39,008-square-foot center is located inside the Sangam DMC High-Tech Industry Center in Seoul and features five training stations with a total of seven da Vinci systems, […]

Sterigenics parent company is now Sotera Health

Sterigenics International said today that it has changed the name of its parent company to Sotera Health, with Nelson Labs, Nordion and Sterigenics as Sotera’s three operating companies. The new name drew its inspiration from the name of the Greek goddess of safety, Soteria, and is meant to reflect the company’s commitment to global health.

Chesapeake IRB, Schulman IRB merge to form Advarra

Chesapeake IRB and Schulman IRB have merged to form Advarra, a new provider of IRB, institutional biosafety committee (IBC) and research compliance services. “By coming together as Advarra, we are merging the highest quality review organizations in the industry,” Jeffrey Wendel, president and CEO of Chesapeake IRB said. “Through a customer-centric integration, we will be

Greenlight Guru adds Grow to quality management software platform

Greenlight Guru recently announced the introduction of its Grow software product to assist medical device companies with quality management after product launch. The Indianapolis-based company’s first product, Go, focused on helping medtech companies utilize design control, risk management and document management software to bring FDA and ISO-compliant medical devices to market in less time. Many

Report: Q3 medical device recalls down 39%

Medical device recalls have declined 39% for the third quarter, settling at 167, the lowest quarter the US has seen since the fourth quarter of 2011, according to a new Stericycle Expert Solutions report. Recalled units were up, however, rising 1% to 68 million which positioned it higher than 16 of the last 19 quarters, […]

Haemonetics to cut 11% of workforce

Haemonetics (NYSE:HAE) said today that it plans to cut roughly 11% of its global workforce as it looks to pare $80 million from its annual cash burn by the end of fiscal 2020. The Braintree, Mass.-based blood management company said it plans to eliminate 350 positions by the end of its fiscal year in April. The company reported […]

Avinger inks $15m share purchase deal

Avinger (NSDQ:AVGR) said today it inked a $15 million stock purchase agreement with Lincoln Park Capital Fund. Through the deal, the Redwood City, Calif.–based company said it will have the right and sole discretion to sell $15 million worth of shares over a 30-month period to Lincoln Park Capital, with proceeds slated to support working capital

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