Tag Archives: device

FDA Ends Months-Long FOIA Battle Over Medical Device Failures, Says Putting Database Online ‘Satisfies’ KHN Request

The Food and Drug Administration responded Wednesday to a Freedom of Information Act request filed months ago, noting that the information sought by Kaiser Health News “is now posted online.” KHN had filed a series of FOIA requests, beginning in September 2018, seeking hidden reports of malfunctions or injuries tied to scores of medical devices.… Read More »

Marketing OK’d for Device to Help Reduce IBS Symptoms in Adolescents

News Consumer News Marketing OK’d for Device to Help Reduce IBS Symptoms in Adolescents TUESDAY, June 11, 2019 — The IB-Stim has received marketing approval from the U.S. Food and Drug Administration as the first medical device used to help alleviate functional abdominal pain in 11- to 18-year-old patients with irritable bowel syndrome (IBS), the… Read More »

SmartBottle Opioid Administration Device: Interview with Leila Smith of Ethimedix

Ethimedix, a Swiss medical device company, has developed the SmartBottle, a drug administration device for analgesics. The device is a programmable “lockbox” which allows for the controlled administration of single doses of opioid painkillers, reducing the potential for addiction and abuse. In view of the current opioid crisis, controlling access to prescription analgesics is important.… Read More »

Amazon launches connected medical device brand focused on diabetes, cardiovascular disease

Amazon’s latest move into the healthcare arena will be focused on helping consumers manage their diabetes or cardiovascular conditions, according to an announcement from Arcadia Group, a brand consultancy firm partnered with the online retail giant. The two companies have launched a new exclusive line of consumer-use medical devices, called the Choice brand, that has… Read More »

Osteoporosis and vertebral compression fractures: Advocacy groups and medical device maker spin misleading message

In case you ever wondered, October 20th is World Osteoporosis Day. In preparation, two advocacy groups — the National Osteoporosis Foundation and the National Bone Health Alliance — have joined forces with Medtronic, the world’s largest medical device maker, to raise awareness about what they consider to be an “under-diagnosed” problem: vertebral compression fractures (VCF) from… Read More »