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To clear up any confusion about what the FDA considers delaying, denying, limiting, or refusing a drug or device inspection, the agency released a draft guidance on Thursday.
Patients who tested positive for peripheral artery disease (PAD) when screened using Selmer Scientific’s QuantaFlo in-home test showed significantly increased cardiac and adverse limb events in the follow-up period, according to a study reported in the peer-reviewed journal AJPM Focus. Read More
A federal court in California has dismissed all claims against RST-SANEXAS by Vanguard Clinic and several other plaintiffs about the company’s alleged misleading statements about insurance reimbursement for services for the company’s neoGen pain management devices.
The technology can enable surgeons to limit instrument movement based on a two-dimensional projection during surgery combined with pre-operative imaging.
Valo Health announced positive results of a five-year collaboration with the FDA to study the potential of cardiac contractility modulation (CCM) to treat heart failure patients using human engineered cardiac tissues to assess the device’s safety.