Medtech stories we missed this week: Nov. 17, 2017

From Skyline Medical’s joint venture to Lensar receiving FDA clearance and CE Mark, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Skyline Medical launches JV deal with Helomics Skyline Medical announced in a Nov. 15 press release that it has signed a joint venture agreement with Helomics.

How to select sterile barrier systems for reusable medical devices

Sterile barrier systems are key components in medical device sterilization, so selecting the right barrier is essential. Jason Pope, Nelson Labs Reusable medical devices, prior to use in healthcare facilities, must undergo validation testing to demonstrate the effectiveness of the cleaning instructions and the microbiocidal instructions that will be provided to the healthcare facility. Often, the

Brazilian regulators propose easier market pathway for low-risk medical devices and IVDs

By Stewart Eisenhart, Emergo Group Medical device and IVD regulators in Brazil plan to loosen market access for low-risk devices and IVDs by introducing a notification-only registration system for these products. 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

FDA approves first pill with sensor to track ingestion

The FDA today approved Abilify MyCite, the first drug in the U.S. to have an ingestible sensor embedded within the pill that can track if the medication was taken. The drug-device combination product is indicated for the treatment of schizophrenia, acute treatment of manic and mixed episodes linked with bipolar I disorder and as an […]

Trump nominates pharma insider Azar to lead HHS

The Trump administration today nominated Alex Azar, who spent nearly 10 years at Eli Lilly (NYSE:LLY) after working in the second Bush administration, as secretary of the U.S. Health & Human Services Dept. The former HHS head, Dr. Tom Price, resigned in September after days of fending off criticism over chartered flights he took on the public dime. […]

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

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 […]

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, […]

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

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

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