Spark Biomedical announced today that the FDA granted breakthrough device designation to its transcutaneous electrical nerve stimulator designed to reduce signs and symptoms of neonatal opioid withdrawal syndrome (NOWS). NOWS results from exposure to prescription or non-prescription opioids such as methadone or heroin during pregnancy. Currently, no nationwide standard of care exists for managing NOWS, although […]
opioid crisis
Could Altair Medical’s wearable reduce opioid deaths?
Altair Medical announced that it won FDA breakthrough device designation for its Respmeter wearable biosensor device for opioid-induced respiratory depression (OIRD). Glasgow, Scotland–based Altair Medical’s Respmeter is a chest-worn wireless sensor designed to detect OIRD, a common side effect of using opioid drugs. The Respmeter monitors and analyzes respiratory patterns by using proprietary algorithms. Once […]
FDA clears generic Narcan nasal spray
The FDA announced today that it has approved the first generic naloxone hydrochloride nasal spray, a life-saving medication that is designed to stop or reverse opioid overdose effects. The FDA also said that it is planning new steps to prioritize the review of other generic drug applications that treat opioid overdose. Nearly 400,000 people have […]
How NeuroMetrix seeks to better relieve pain with AI
NeuroMetrix plans to add artificial intelligence to the latest iteration of its Quell transcutaneous electrical nerve stimulation (TENS) device. AI will allow Quell 2.0 to tailor treatment to each individual user, according to the Waltham, Mass.–based based company. Launched in September 2018 Quell 2.0 is 50% smaller and 20% more powerful than the original Quell, […]
Medtronic risk prediction tool could help prevent opioid deaths: Here’s how
Medtronic officials continue to hone their arguments for how the company’s capnography and oximetry systems could reduce potentially deadly opioid-induced respiratory compromise. The medical device giant on Feb. 17 announced preliminary results of its Prodigy study, in which the company’s Microstream and Nellcor monitoring technology provided continuous capnography and oximetry for 1,496 patients across 16 sites in the […]
5 top stories that mattered for medtech in 2018
The medical device industry faced some major challenges over the past year, from increased media scrutiny to regulatory uncertainty in both the U.S. and E.U. It’s worth noting, though, that many things have been going right for medtech. More than half of the roughly 100 largest medical device companies in the world saw their stock […]
The top 10 medical disruptors of 2019
The Cleveland Clinic for the past 16 years has predicted what the top 10 medical disruptors will be for the following year. The health provider seeks input from 150 to 200 of its physicians, hailing from each of its institutes. The result is 300 to 400 suggestions, which the clinic then narrows down to 150. […]
Medtech reporting would change under new opioid law
A section of the recently-passed bill to address the opioid crisis could have implications for medtech. The 250-page Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT for Patients and Communities Act) contains a provision that would require manufacturers of certain medical devices, drugs and biologics covered by Medicare, Medicaid, […]
FDA launches medical device innovation challenge to combat opioid crisis
The U.S. FDA today announced that it has launched an innovation challenge to encourage the development of medical devices to help reduce the country’s opioid abuse crisis. The hope is that the challenge will result in new medtech including digital health technologies and diagnostic tests to help detect, treat and prevent addiction, according to FDA. Go […]
How medtech could stop the drug overdose crisis in the U.S.
The opioid epidemic is one of the deadliest problems facing the U.S. today. Through the development of new pain management devices, medtech could be a leader in solving the crisis. The prescription opioid overdose crisis in America didn’t start until the late 1990s, when pharmaceutical companies touted prescription painkillers that weren’t supposed to be addictive. […]
7 medical devices combating the opioid crisis
Opioid-related deaths have become an epidemic in the U.S., garnering attention from the White House, the FDA and many other governmental bodies. From 2000 to 2014, nearly half a million Americans died from drug overdoses. In 2015, more than 50,000 people died from drug overdoses, and 33,000 were opioid-related. Prescription overdoses continue to cause more […]
