Regulatory and Compliance

NCI Director to Take the Helm of FDA Until Permanent Replacement is Named

Norman Sharpless, director of the National Cancer Institute, will become “acting” commissioner of FDA after commissioner Scott Gottlieb abruptly announced he is leaving the position.

FDA to Take a Hard Look at Surgical Staple Risks

The agency released a letter to healthcare providers pointing out the risks and said it would hold a public advisory committee meeting.

FDA Slammed for 'Hiding' Device-Related Injury Reports

An investigative report claims FDA is hiding millions of adverse event reports from the public under the guise of an alternative summary reporting program.

Medical Device Recalls Spike Again - Updated

FDA recalls spiked again in July. Here's how the number of 2019 recalls (so far) compares with previous years.

FDA Commissioner Scott Gottlieb to Step Down

A successor has not yet been named and it is expected that Gottlieb will leave the position sometime next month.

Twitter Responds to 'Unbelievable News' of Gottlieb's Resignation

Many industry stakeholders took to Twitter on Tuesday to respond to the news that FDA Commissioner Scott Gottlieb is stepping down.

FDA Flirts with the Learning Curve

How many robotically assisted surgeries should surgeons perform in order to be good enough?

A New Task Force Promises to Cut Through Emergency Diagnostics Clutter

Product launches, study results, and approvals were signs of a pretty significant week in diagnostics, as FDA, CMS, and CDC formed a task force to make diagnostics rapidly available during public health emergencies.

FDA Cautions Against the Off Label Use of Surgical Robotics

FDA issued a safety notice to doctors and patients regarding the use of robotically-assisted surgical devices for mastectomy and other cancer-related procedures.

Thermography Is Not an Alternative for Mammography, FDA Warns

FDA has warned several facilities against illegally marketing and distributing unapproved thermography devices as a sole screening device for breast cancer and other diseases.

SyncThink Scores FDA Breakthrough Device Designation for Concussion Tech

The company's eye-tracking technology has the potential to solve an important unmet need for providing objective measurements to aid in the assessment of concussion.

A New Regulatory Strategy?

Is asking FDA for advice and then not following it a good plan?

Another Significant Milestone in the Diabetes Space

Tandem Diabetes Care has received a nod from FDA for the t:slim X2 insulin pump and the approval opens up a new device category – Alternate Controller Enabled Infusion Pumps.

GI Dynamics’ 2nd Chance at an EndoBarrier Pivotal Trial

The company has had significant struggles with the EndoBarrier in the past, but a nod from FDA and the IRB to begin a new pivotal trial might be step back in the right direction for the technology.

Cybersecurity: Is Medtech Cruisin' for a Bruisin'?

What should medical device companies be doing to mitigate cybersecurity risks? One expert shared his insight on the subject during MD&M West 2019.

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