MiMedx cannot recoup $40.2 million from two former executives convicted in a scheme to defraud the company and its investors, a federal judge has ruled. “MiMedx is not a “victim” under federal law and is therefore not entitled to recover restitution from either man, Manhattan U.S. District Court Judge Jed Rakoff wrote in a ruling […]
Qardio inks EHR deal with Redox
Qardio said today that its remote patient monitoring tech, QardioMD, will work with any provider that uses Redox to exchange healthcare data. The partnership will enable remote care delivery and translate electronic health record (EHR) data into information for clinical decision-making, according to the companies. Get the full story on our sister site, Medical Design & Outsourcing.
ITC takes up AliveCore patent complaint against Apple
The U.S. International Trade Commission (ITC) has agreed to investigate if Apple has imported devices that infringe three patents held by AliveCor. AliveCor filed the ITC complaint in April, alleging that Apple violated U.S. tariff law by importing certain Apple watches that infringe patents for its ECG technology. Mountain View, Calif.-based AliveCor wants the trade commission […]
7 digital health startups you need to watch in 2021
Digital health has skyrocketed in recent years. The pandemic has only propelled its growth by keeping patients away from doctors’ offices in droves. Thanks to the continued adoption of smartphones, the growth of connected medical devices and changes in patients’ and providers’ preferences, digital health will only continue to expand through the 2020s and beyond, […]
Feds want more input on materials with ‘high-profile safety concerns’
The FDA today asked the public to submit comments on how devices that contain certain materials should be labeled. The materials are ones to which patients have long-term exposure — contact time exceeding 30 days — and that have presented “high-profile safety concerns,” according to the agency. They include female sterilization devices, metal-on-metal hips and […]
Emergo by UL, MedCrypt pair on cybersecurity
Emergo by UL and MedCrypt will jointly offer cybersecurity risk management and mitigation for connected medical devices and systems. Medtech and healthcare technology consulting group Emergo and healthcare cybersecurity developer MedCrypt said this week that they will refer prospective clients to one another and co-market their cybersecurity software solutions, consulting and risk management services to ensure clients understand […]
Medline, Sterigenics failed to report EtO emissions to EPA, report says
Two companies that use ethylene oxide (EtO) to sterilize medical devices failed to report emissions of the toxic gas to the U.S. Environmental Protection Agency, according to a report by the Chicago Tribune. Medline Industries and Sterigenics, both headquartered in Illinois, have also operated medtech sterilization operations in the state. Medline continues to do so, and Sterigenics decided in September 2019 not to […]
5 of the latest cardiac tech insights out of ACC.21
The American College of Cardiology’s 70th Annual Scientific Session has produced some positive news about some controversial cardiac tech. Drug-coated stents, which a 2018 study linked to late-stage death, were shown to be non-inferior to non-drug-coated stents in patients with peripheral arterial disease. And a new study of renal denervation that used a different methodology […]
CMS delays Medicare payments for breakthrough devices until December
Medicare coverage for FDA-designated breakthrough medical devices will have to wait several more months, despite broad support. The Centers for Medicare and Medicaid Services (CMS) issued a final rule on Medicare Coverage of Innovative Technology (MCIT) in January, granting coverage for breakthrough devices the same day as their FDA approvals, for up to four years. Immediately […]
This imaging device could be a breast cancer treatment breakthrough
OncoRes Medical’s system may detect cancer cells on a microscopic scale during a lumpectomy, potentially averting the need for a second breast cancer surgery. Having breast surgery to remove a cancerous lump is traumatic enough. Learning that you’ll need another operation to remove cancer cells that the surgeon couldn’t detect the first time only adds […]
Abbott recalls pacemakers that may short circuit
Abbott is recalling certain pacemakers that may short circuit because they can allow moisture inside, according to the FDA. The recall covers 61,973 Assurity and Endurity pacemakers manufactured by St. Jude Medical and distributed from April 2015 to February 2019. (Abbott acquired St. Jude in 2017). A small number of devices from that time frame […]