The FDA wants more money from Congress for the coming fiscal year — and more power, too. Out of its $6.5 billion total budget, the agency is asking $676.55 million for its medical device program. That includes $571 million for the Center for Devices & Radiological Health (CDRH) and $105.4 million for the Office of Regulatory […]
opioid crisis
Purdue Pharma boosts opioid lawsuits settlement offer to $4.28 billion
Purdue Pharma has proposed paying an additional approximately $500 million in cash to settle hundreds of thousands of opioid lawsuits filed against it. As part of a proposed bankruptcy settlement, the payments would be spaced out over the next decade. The Sackler family that owns the company has earlier agreed to pay an additional $4.2 […]
Spark Biomedical wins FDA breakthrough nod for newborn opioid withdrawal relief device
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 […]
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 […]
