In the latest salvo of the ongoing battle between Apple Inc. and Masimo Corp. over the use of a blood oxygen technology, a U.S. federal appeals court paused an International Trade Commission (ITC) ban on Apple’s watches. Apple reported on Dec. 19 that it would pull the Apple Watch Ultra 2 and Apple Watch Series 9 from its website on Dec. 21 and from its retail locations after Dec. 24, in response to an exclusion order issued by the ITC in October.
The Securities and Exchange Commission (SEC) charged Laura Tyler Perryman, the former CEO and co-founder of Stimwave Technologies Inc., with defrauding investors out of approximately $41 million by making false and misleading statements about one of the company’s products. According to the SEC’s complaint, the Stimwave device comprised several components, one of which was a fake, non-functional component that was implanted into patients’ bodies.
The U.S. FDA opted not to pursue one form of medical device harmonization via the Global Harmonization Working Party (GHWP), as it reported it will withdraw from the organization.
Philips Respironics Inc.’s nightmares with its Dreamstation continuous positive airway pressure (CPAP) line of products continued with a fresh warning from the U.S. FDA of reports involving thermal issues with a newer iteration of the machine, some of which cited patient injuries.
The time to diagnosis of sepsis infection to a patient in the hospital can be critical, with underdiagnosis resulting in rapid deterioration, risk of organ damage and need for readmission, and overdiagnosis leading to the avoidable and sometimes serious health consequences of overtreating patients with broad-spectrum antibiotics.
In a new report from the U.S. International Trade Commission (USITC), concerns about global inequities accessing diagnostics and medicines for COVID-19 reveal that there are varied and divergent opinions on whether the intellectual property (IP) protections that support the development of new medicines may also act as a barrier to access, particularly in developing countries. In December 2022, U.S. Trade Representative Katherine Tai asked the USITC to respond and identify significant data and information gaps.
The U.S. Congress passed a five-year reauthorization of the Medical Device User Fee Amendment (MDUFA) agreement, the fifth iteration of this user-fee agreement since the system's implementation in 2002, after many months of back and forth with the med-tech industry. The extension passed as part of a temporary spending bill needed to avoid a partial government shutdown ahead of Friday’s deadline. The spending bill passage gives lawmakers a reprieve until after the midterm elections when they'll need to figure out a longer-term funding plan for the fiscal year ending Sept. 30, 2023.
Keeping you up to date on recent developments in orthopedics, including: Skin and bones repaired by bioprinting during surgery; Researchers use AI to detect wrist fractures; Smart Score quantifies clinical outcomes for shoulder arthroplasty patients.
Keeping you up to date on recent developments in orthopedics, including: 3D biomaterial used as 'sponge' for stem cell therapy to reverse arthritis; New biomaterial regrows blood vessels and bone, RCSI research; Without major changes, gender parity in orthopedic surgery will take two centuries.
Keeping you up to date on recent developments in orthopedics, including: X-rays confirm promise of new luminescent markers; Pillar of support: Breakthrough discovery could speed up bone implant recovery; New biosealant can stabilize cartilage, promote healing after injury.
