The US agency’s new Office of Digital Transformation will aggregate a number of IT operations under one office to streamline the agency’s work, including its interactions with device sponsors.

The US Medicare agency has proposed to withdraw a rule that would give temporary automatic coverage to breakthrough devices, stating the rule doesn’t meet its evidence threshold and could put patients at risk.­­­­­­­

Gone are the days when notified bodies needed to promote themselves to gain business. Now industry is left struggling to find services ̶  and the EU regulatory outlook is becoming worrisome.

The authorization means that similar technology, known as interventional cardiovascular implant simulation software, can be cleared for market via the 510(k) pathway in the future. 

Nearly four months after the full application date of the EU’s Medical Device Regulation, the EU standards bodies have updated the most critical medtech standard to align it with the new EU medtech regulations.

The move is consistent with a 2007 guidance document, which said that devices that use human cells or tissue to create a therapeutic agent at the point of care should be regulated as biologics.

The US agency has warned health care providers that certain devices used to warm fluids for bodily circulation could leach dangerous levels of aluminum.

Now-defunct Canadian manufacturer Eco-Med Pharmaceutical Inc. initiated the recall of its gels and lotions – sold under an array of product names – because there’s a chance they could be contaminated with harmful bacteria.

Gone are the days when notified bodies needed to promote themselves to gain business. Now industry is left struggling to find services ̶  and the EU regulatory outlook is becoming worrisome.

In this week's podcast Medtech Insight’s Marion Webb gives a summary of this year’s American Academy Of Orthopedic Surgeons annual meeting, where she discusses new products from a range of companies, and interesting meetings with executives. UK-based reporter Barnaby Pickering sheds light on Owlstone Medical’s new diagnostic method, and managing editor Reed Miller highlights a story about the troubled Stereotaxis.

The company also named ZimVie’s management team, led by CEO Vafa Jamali.

Illumina selected seven start-ups to join the third funding cycle of its Accelerator in the US and UK.

A series C funding round will enable Flywheel.io to buy out Radiologics and continue development of its clinical trial data management products.

The move is supported by iRhythm investors and disappointed Dexcom’s shareholders.

The lawsuit says that Allergan repeatedly downplayed the cancer risk its textured breast implants posed as compared to those from other manufacturers.

Illumina selected seven start-ups to join the third funding cycle of its Accelerator in the US and UK.

The combination of Zoll Medical and Itamar Medical would help strengthen the collaboration between the worlds of cardiology and sleep medicine, Jon Rennert, Zoll’s CEO said.

Patients with obstructive sleep apnea treated with positive airway therapy experienced significantly better outcomes than those not receiving the treatment, according to a new European study. After a series of setbacks, the study is positive news for sleep apnea device makers.

At the live AAOS conference, exhibitors, including major orthopedics players, demoed digital innovations, software-enabled technologies, robotics and smart implants that are expected to create efficiencies in the surgical continuum and provide data to improve outcomes.

June, July and August brought a number of important new approvals and trial announcements from the major cardiac device companies. Here are some of the highlights you might have missed during the summer.

In this week’s podcast, Marion Webb discusses the future of robotic surgery and Barnaby Pickering breaks down the trauma fixation device market.