Hologic Inc. has gained approval from the U.S. FDA to add a diagnostic claim to its HIV type 1 viral load monitoring assay. This makes the Aptima HIV-1 Quant Dx assay the first dual-claim assay in the U.S., allowing both viral load monitoring and diagnosis. For laboratories that use the assay, the dual claim allows for consolidated testing on one automated platform, adding to efficiency.
The U.S. FDA cleared Alivecor Inc.'s Kardia AI V2 interpretive electrocardiogram (ECG) algorithm for use in its personal ECG app and devices. Currently, the Kardia line permits consumers to take a 30-second medical grade ECG at home and instantly see whether they are exhibiting symptoms of atrial fibrillation, bradycardia, tachycardia or have normal heart rhythm.
Two U.S. federal agencies at the Department of Health and Human Services (HHS) have finalized rules that affect how drug and device makers interact with the health care system, but under the Congressional Review Act, neither rule can go into effect until February 2021. This timeline comes up a couple of weeks after President-elect Joseph Biden is sworn in, thus raising the risk that the new administration at HHS will either modify or overturn these rules altogether.
When U.S. President Donald Trump and Health and Human Services (HHS) Secretary Alex Azar announced last week the Jan. 1 launch of a Medicare Part B most-favored nation (MFN) drug pricing model and a final rule to end Medicare’s safe harbor for the rebates that create a black box around the pricing of Part D drugs, they called the reforms “historic.”
Eargo Inc., a medical device company specializing in hearing aids, reported $18.2 million in third quarter revenue, driven by sales of the company’s Neo Hifi hearing aid system and a decrease in the sales return accrual rate. Revenue was up 135% over the third quarter of 2019.
Johnson & Johnson (J&J) said it will deliver its differentiated value propositions for patients Thursday as it provided details on its Ottava platform during its Virtual Medical Devices Update. Analysts appear to have left the meeting with a good impression. “We came away impressed with JNJ's digital surgery vision & holistic approach,” wrote Cowen’s Josh Jennings.
The U.S. FDA’s device center is re-examining its approach to public safety communication, but Mark Leahey of the Medical Device Manufacturers Association said on a recent webinar that the FDA sometimes goes silent after an initial consultation with device makers about a safety signal.
Hot on the heels of news that two vaccines for COVID-19 are nearing market readiness, two companies have broken away from the pack of assay manufacturers to offer quantitative antibody tests that can verify whether the vaccines provide effective, lasting protection. Siemens Healthineers and Imanis Life Sciences both claim to be first to develop scalable, quantitative neutralizing antibody tests.
Varian Medical Systems Inc. revealed that the first clinical trial of FLASH therapy has kicked off, with the initial treatment taking place at the Cincinnati Children's/UC Health Proton Therapy Center. The study, which saw the first patient treated this week, involves the investigational use of Varian's Probeam particle accelerator modified to enable radiation therapy delivery at ultra-high dose rates.
The casual observer may think that physician speaker programs sponsored by makers of drugs and medical devices have drawn less attention from U.S. federal attorneys, but reality has failed to meet that expectation. Mark Gardner, managing attorney of Gardner Law of Stillwater, Minn., said on a Nov. 19 webinar that “there’s a lot coming through right now in terms of settlements,” including a settlement with a drug maker that sent the company into bankruptcy.
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