Topic:

Regulatory

Latest Headlines

Latest Headlines

Mobile medical app regulation will only get more challenging--and important

The FDA is trying to regulate mobile medical apps lightly, but will have a hard time doing so as they become more sophisticated. Consider a future of mobile blood pressure and blood glucose monitors.

St. Jude flexible cardiac catheter approved in EU, aims for FDA

St. Jude Medical is hoping to strengthen its franchise in ablation catheters--thin, flexible wires inserted non-surgically into the heart to treat cardiac arrhythmia. Its FlexAbility irrigated ablation catheter has garnered a CE Mark in Europe, where it has marketed the TactiCath contact-force sensing irrigated ablation catheter since 2012. The company hopes to get FDA approval by year end for both FlexAbility and TactiCath.

Avastin nabs second-in-a-row priority review, this time in ovarian cancer

Last week, it was priority review for cervical cancer. This week, it's the fast track for difficult-to-treat ovarian cancer.

FDA fast-tracks Roche's Avastin for tough-to-treat ovarian cancer

Last week, it was priority review for cervical cancer. This week, it's the fast track for difficult-to-treat ovarian cancer. That's the record for Roche's Avastin, which is now up for quick FDA approval of two new indications.

Do testosterone meds boost heart attack risks? FDA asks advisory panels to weigh the data

The FDA has zoomed in on testosterone products for the cardiovascular risks they might pose to consumers, even slapping a new warning on their official labels. Now, the agency has called a special advisory committee meeting to probe two trials that flagged an increased risk of heart attack in men using the meds.

Sage takes to the FDA fast track with its lead rare disease drug

Fresh off grossing $103.5 million in an overstuffed IPO, Cambridge, MA's Sage Therapeutics has secured the promise of a speedy FDA review for its top prospect, a treatment for a rare seizure disorder.

FDA again warns that Texas compounder's products may not be sterile

The FDA continues its battle with a Dallax, TX compounding pharmacy which it says is not meeting sterility standards.

FDA approves expandable implant for spinal fusion surgery

The FDA has cleared Expanding Orthopedics's FLXfit implant for spinal fusion surgery, the Israeli company announced July 21. 

FDA clears Varian soft tissue transponder to treat cancer

Varian Medical Systems scored FDA 510(k) clearance for its soft tissue transponder for radiotherapy and radiosurgery treatments.

Patient groups argue for faster med tech FDA approvals at industry meeting

The president of the Society for Cardiovascular Angiography and founder of the Children with Diabetes Foundation made their case for faster approvals at a July 17 AdvaMed hearing in Washington, DC.