Medical Device Legislation
‘Substantial threat’: ASDS provides regulation status update of medical spas
The American Society for Dermatologic Surgery Association has called on legislators for medical spa regulation following the publication of its study which showed a continued lack of physician supervision.
Hooked on ID with Kelly Zabriskie, MLS, CIC, FAPIC
Science has always been a passion of mine. I worked in research and microbiology for years, and while at home, I would read science journals, try to identify diseases from case studies and watch all the science shows.
Philips Respironics agrees to finalized FDA consent decree
Philips Respironics and Philips Holding USA agreed to the FDA’s finalized consent decree against the company, according to a company press release.
Inspire Medical Systems receives expanded indication for sleep apnea therapy
The FDA has approved an expanded indication for a proprietary neurostimulation technology to treat those with severe obstructive sleep apnea.
FDA grants MRI conditional use for implantable sleep apnea therapy
The FDA has granted conditional use with MRI to an implantable transvenous phrenic nerve stimulation therapy for adults with moderate to severe central sleep apnea.
California legislation requires accessible epinephrine in schools
When a child has an anaphylactic reaction in school, prompt administration of epinephrine can be lifesaving. Yet autoinjectors often are kept under lock and key in the nurse’s office, and school personnel lack the training to use them.
FDA grants breakthrough device designation for at-home depression treatment
The FDA has granted breakthrough device designation to a Finnish medical company for its portable, patient-administered neuromodulation device to treat depression.
California governor vetoes optometric laser bill
California Gov. Gavin Newsom vetoed Assembly Bill 2236, which would have allowed optometrists in the state to use therapeutic lasers, remove eyelid lesions and perform corneal crosslinking.