Category: Regulatory/ComplianceSyndicate content

Sensus Healthcare wins another indication for melanoma treatment

May 30, 2013 by Sony Salzman

The FDA says Sensus Healthcare's non-surgical skin cancer treatment can be used to treat keloid scars.

Sensus Healthcare wins another indication for melanoma treatment

The FDA granted another indication for Sensus Healthcare's topical skin cancer device, for treating keloid scars.

The Danbury, Conn.-based medical device company said its SRT-100 "superficial radiotherapy" product has already won 510(k) clearance from the federal watchdog for treating some skin cancers.

Investors shrug off FDA warning letter for Edwards

May 30, 2013 by Brad Perriello

Shares of Edwards Lifesciences tick up today despite news of an FDA warning letter for the implantable heart valve maker.

Investors shrug off FDA warning letter for Edwards

Investors seemed unfazed by news of a warning letter from the FDA for Edwards Lifesciences (NYSE:EW) over a Utah cardiac surgery systems plant.

FDA enforcement letter: Preview of U.S. mHealth regulations?

May 30, 2013 by MassDevice

The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.

Global Medicine

By Stewart Eisenhart, Emergo Group

The US Food and Drug Administration recently issued a letter to Biosense Technologies, developer of the uCheck Urine Analyzer mobile medical application, stating that the firm's product qualifies as a medical device and must have 510(k) clearance in order to be sold in the US.

Device makers object to FDA's proposed recall guidance | On Call

May 30, 2013 by Arezu Sarvestani

Medical device titan Boston Scientific and industry lobbying group AdvaMed respond to the FDA's latest draft guidance on medtech recalls, warning that the new language may cause more confusion than it clears.

MassDevice On Call

MASSDEVICE ON CALL — The FDA's recent attempt to clear up confusion about official recall requirements got some negative reactions from members of the medical device industry, among them lobbying group AdvaMed and medical device company Boston Scientific (NYSE:BSX).

EuroZone OKs Medtronic's CoreValve for valve-in-valve implants

May 29, 2013 by Brad Perriello

Medtronic wins CE Mark approval in the European Union for its CoreValve heart valve, for use in valve-in-valve procedures to replace failing surgically implanted replacement valves.

EuroZone OKs Medtronic's CoreValve for valve-in-valve implants

Medtronic (NYSE:MDT) said EuroZone regulators OK'd a pair of its CoreValve heart valves for use in valve-in-valve replacement procedures, touting the CE Mark approval as the 1st ever worldwide.

Parkinson's Disease: Boston Scientific's deep-brain stimulation imaging guide makes the cut in Europe

May 28, 2013 by Sony Salzman

Boston Scientific wins CE Mark approval in the European Union for its Guide imaging system, designed to aid in the placement of electrodes for deep-brain stimulation therapy to treat Parkinson's disease.


European regulators gave Boston Scientific (NYSE:BSX) the green light for its Guide 3D imaging system, touting it as the "world's first" deep-brain stimulation visualization system.

The Guide device is designed to create a simulated 3D map of the brain's electrical output, to help guide the placement of electrodes that deliver electrical pulses to the brain.

FDA considers more stringent oversight of blood lancet devices

May 28, 2013 by Sony Salzman

An FDA advisory panel will meet next month to consider more rigorous regulatory oversight of blood sampling devices.

FDA logo

The FDA is taking a closer look at blood sampling devices to determine whether the technology merits a higher level of regulatory oversight.

Currently classified as class I, blood lancets are only subject to general regulatory control. However, the FDA will host an advisory committee meeting on June 26 to determine whether blood lancets merit class II or class III regulatory status. The committee will offer its recommendation to the FDA based on the scientific data presented.