Regulatory and Compliance

Operating Rooms Get a Dose of Augmented Reality

Mariner Endosurgery has received a nod from FDA for an augmented surgical navigation system.

Colorectal Cancer Screening Pill to Be in US Pilot Study

Check-Cap received CE mark for its C-Scan Capsule in January of this year, now the Isfiya, Israel-based company is setting its sights on the U.S. market.

Reprocessed Duodenoscopes Are Still Too Dirty

FDA said interim results from sampling studies indicate higher-than-expected contamination rates after reprocessing of duodenoscopes currently on the market.

Can Olympus Finally Put Its Scope Problems in the Past?

Olympus agreed to pay $85 million to settle a federal investigation of its that began in 2015. A former executive also pleaded guilty and faces up to a year in prison.

FDA Wants to Change the De Novo Pathway

FDA proposed a new rule that, if finalized, could motivate more companies to choose the de novo pathway for new devices that do not have a modern predicate.

What Can Medtech Expect with the New Congress?

Oversight of industry could change, just as it has in the past.

REACH FAQs for Medical Device Professionals

The EU regulation may have been around for more than a decade, but there is still a lot for medtech to learn.

Does It Make Sense to Retire Old Predicate Devices for FDA Clearance?

From 2015 through 2018, about 20% of 510(k) clearances were based on substantial equivalence to a predicate device that was more than a decade old. Should FDA continue to allow this practice, or should older devices be retired as predicates?

Oscar Recalls Pacing Leads Due to a Connection Cap Malfunction

A medical device supplier is recalling certain lots of its temporary bipolar pacing leads that are used in conjunction with a compatible external pulse generator for the temporary pacing and sensing of the heart.

Zimmer Biomet Recalls 1,300 Bone Growth and Spinal Fusion Stimulators

Zimmer Biomet initiated the recall due to the lack of adequate validation and controls to ensure that final products were clean and free from bacteria and chemical residue.

FDA Eyes Changes to 510(k) Program

FDA is taking what it calls "transformative new steps" to modernize the agency's 510(k) program to keep pace with the increasing complexity of rapidly evolving medical technology.

Investigative Report Casts a Troubling Light on the Medical Device Industry

AdvaMed has taken issue with the investigative report, arguing that it fails to look at both the challenges and the accomplishments of the medical device industry.

FDA Gets out in Front of Injection Pen Errors

The agency has issued a labeling change request to injection pen manufacturers.

Does More FDA Oversight Equal Better Compliance?

A new report explores FDA's increased oversight in the past decade.

Is Progress on MDR and IVDR Happening Fast Enough?

One year into the transition periods for the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), industry experts continue to express concern that more progress is needed to help companies prepare for the new regulations within the limited transition period.

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