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The FTC and HHS have teamed up on a campaign about the privacy and security risks associated with online tracking technologies integrated into mobile health apps and websites with a letter to 130 hospital systems and telehealth providers. Read More
The Senate Health, Education, Labor and Pensions (HELP) Committee has advanced reauthorization of the 2006 Pandemic and All Hazards Preparedness Act (PAHPA), allowing the FDA to require that manufacturers notify the agency of potential product shortages when there’s no public health emergency (PHE). Read More
A regulatory affairs specialist for an eastern Pennsylvania medical device company has pled guilty to fabricating documents on FDA letterhead representing that two of his company’s products had received 510(k) clearances when, in fact, he had never made any submissions for the devices. Read More
Enabling more rapid Medicare coverage of medical technology innovations through support of CMS’s proposed Transitional Coverage for Emerging Technologies (TCET) was the goal of several devicemakers who spoke in support of the proposal at a recent House Energy and Commerce Health Subcommittee meeting. Read More
Medtronic’s recall of more than 348,000 implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) has been deemed class I by the FDA, the most serious type of recall as use of the device may cause injury or death. Read More
The Department of Justice (DOJ) and the FTC have issued draft guidelines the government will use to determine whether a merger may violate anti-trust laws by risking lessened competition now and in the future. Read More
CMS has proposed removing the national coverage determination for the positron emission tomography (PET) beta amyloid imaging needed to diagnose the onset of Alzheimer’s disease and prescribe the newly approved antiamyloid antibody drug Lequembi (lecanemab). Read More