Food & Drug Administration (FDA)
FDA gives Invacare green light on limited manufacturing at Ohio plant
Sorin’s Smartview remote patient monitoring system wins FDA approval
Sorin Group (BIT:SRN) said it’s beginning an immediate launch for the Smartview remote patient monitoring system now that it has FDA approval in hand for the system.
The Italian cardiovascular device maker said the federal watchdog agency OK’d the Smartview system for use with its Paradym RF cardiac rhythm therapy devices.
Biolase gets FDA nod for new tissue laser
Biolase (NSDQ:BIOL) won 510(k) clearance from the FDA for its WaterLase iPlus, a laser used for soft-tissue orthopedic procedures.
The clearance opens up a $2.6 billion market opportunity for the WaterLase device, according to a company statement.
FDA proposes warnings on tanning beds
In the wake of new evidence that tanning beds increase melanoma risk in young people, the FDA proposed a new warning label for all tanning beds to dissuade use by minors.
The order would require all manufacturers to place a warning label on tanning beds and promotional material warning of danger to minors. This would be similar to the agency’s regulation of messaging on cigarette cartons, but it marks a new step to regulate sunlamps as a higher-risk device.
FDA data shows increase in warning letters to medical device firms since 2005
By Stewart Eisenhart, Emergo Group
US Food and Drug Administration medical device quality system inspectors have issued warning letters to manufacturers at an increasing rate since 2005, FDA inspection records show.
Updated: Class I recall for Cardinal Health’s filter and anesthesia kits
Updated May 9, 2013, at 2:30 p.m. with a comment from Cardinal Health.
FDA warns of stolen, unsterilized Covidien surgical staples
FDA regulators warned healthcare providers this week that thieves had gotten away with 1 lot of Covidien’s (NYSE:COV) Endo GIA Articulating 60-3.5 Surgical Stapler Reloads.
In addition to being stolen, the devices were labeled " ready for use" but were taken before the staples were actually sterilized, the FDA warned. . The agency’s Office of Criminal Investigation is looking into the theft.
Masimo lands FDA win for pediatric acoustic sensor
Honoring an FDA champion of safe treatments for children
By: Margaret A. Hamburg, M.D.
It has been 11 years since Congress passed the Best Pharmaceuticals for Children Act mandating the creation of the Office of Pediatric Therapeutics (OPT) at FDA. But it has been light years in terms of the progress we have made to ensure that children have access to innovative, safe and effective medical products.
FDA approves Biotronik’s “smaller, thinner” heart rhythm implants
German medical device maker Biotronik today touted FDA approval for its Ilesto 7 line of next-generation implantable cardioverter-defibrillators and cardiac resynchronization therapy defibrillators.
The devices are smaller, thinner and lighter and the new Ilesto DX allows physicians to monitor atrial information and possibly diagnose previously undetected instance of atrial fibrillation.